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Breaking Down Gender Disparities in Cardiovascular ...
Breaking Down Gender Disparities in Cardiovascular ...
Breaking Down Gender Disparities in Cardiovascular Clinical Trials Leadership
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But I'm very excited about this session now. It is something that I conceptualized about a year ago as a need that we have for the women in EP community, and I was very grateful that HRS leadership and HRS itself were very happy to sponsor this. So we got this put together today, and I do hope that we'll have some real action items coming out of this. So I'm going to start, and I just want to lay the framework for what we're dealing with as a community of women in electrophysiology by talking about gender representation in cardiology and EP. And we know that that is low, and I'm going to show you some interesting statistics. And that sort of drives why we all feel that there is a need for this kind of session. So if we look at women in medicine, I think it's pretty well known that the majority of medical students are now women. And some of the most recent data I have, I have a couple of references there, are that almost 55% of medical students are women. If you look at internal medicine residents, that drops to somewhat below half, about 45%, and then it just keeps dropping. So out of all internal medicine residents, they have that almost 50% representation. But if you look at cardiology fellows, it's 27.8%. So fewer women go into cardiology than either primary care or the other subspecialties of internal medicine. And then if you look at electrophysiology fellows and interventional cardiology fellows, among all cardiology fellows, you can see the numbers are pretty low and pretty close. 17.2% for EP fellows, 16.1% of interventional cardiology fellows. And I looked this up just because I had to know the answer, because neurosurgery is such a, you know, sort of this impression that it's very male-dominated. And they have more women in neurosurgery residencies than we have in fellowships in electrophysiology. So we are a minority, but I am glad to see everyone here to have this discussion. So a little few more statistics. If you look at cardiologists in practice, it's a little over 15%. And I think we know that many women who go into cardiology seem to favor non-invasive cardiology, and that's how we wind up with the distribution that I've shown you. Cardiologists in practice, it's just about 10%, so we still stay very, very low. Active female EPs, however that's defined, only represents about 6% of total electrophysiologists. And this is a quote from there. There was no statistically significant, it said changes, but change in the representation of women in electrophysiology over a prolonged period of time. So it's not like this is skyrocketing and that we're getting more and better representation. It's staying about the same. And if you look at the Medicare provider utilization and payment database from 2013 to 2019, 5% of EP operators were women. So even there, it's a pretty low number. It's another way of looking at this, and I have Kamalak Tamarisa, who is going to be one of our panelists, to thank for this slide. And it's looking at female representation in the cardiology pipeline at different career stages. So this is a figure that sort of illustrates the numbers that I just showed you, how you go from medical school graduate and then internal medicine, cardiology, et cetera, et cetera, down to EP, and you can just see how it gets very, very small. And the smaller the percentage that we have, the harder it is to be visible and recognized and given opportunities. So that's something that we do hope to change. There are ways that we can look at increasing the number of women in an EP and EP clinical research. I'm just throwing this out because there are a couple of very interesting articles that I've referenced there. Pam Douglas did one in 2018 in JAMA Cardiology, and it was a survey showing what are the barriers. Umos Rivaz is going to be talking about this in more detail, so I don't want to take anything away from what she's going to talk about. But there are issues of mentors and role models and the paucity of women in leadership positions, whether there's good training for research, perceived and reported barriers for career progression, and issues of work-life balance, and sometimes even sexual harassment and gender discrimination. So I'm sure we'll hear more about that as the afternoon goes on. So now to wrap up and get going with the symposium, the goals of the symposium are to examine the current state of women electrophysiologists' involvement in clinical research, to evaluate their access to opportunities, and then to identify actionable strategies to enhance their participation and leadership in clinical trials. So if we can get close to these by the end of the afternoon, I will be very pleased. So we've split this up into two sessions. The timing in the app, I think, is off. There will be a 20-minute break in the middle. It's very hard to have people sit for four hours straight, and I recognize that. So this is our first session where we're going to be talking about the current state. I've just given the overview of gender representation in cardiology and EP, and then we're going to follow that by looking at gender representation among patients and investigators. There was a survey that was done, and Jeannie Poole is going to talk about that. Barriers, as I said, to succeeding in clinical trials research, and then a panel discussion about the current state of participation and leadership in clinical trials, and we'll go through that as we go on. At 2.50, we'll take a 20-minute break and then come back for the second session that will start at 3.10, and you can see the topics here. The intention here is to work towards solutions. What can we do about what we see from the first session? Looking at ending gender inequality, we'll talk about the clinical trials research program that the American College of Cardiology does, a research network that HRS is developing anyway and how we can use that to our advantage to encourage participation by women in clinical research. And then finally, have a panel discussion about changing the current paradigm, and then wrap up and go to next steps. So we will end there, and then we'll move on to our first speaker. Great. So thank you all for joining, and thanks, Anne. That really sets the stage for what we're going to talk about today. The statistics are really interesting, and I guess we've not made as much progress as we thought. So to introduce our first speaker is Dr. Pamela Mason, who is from University of Virginia, and she is going to talk about gender of principal investigators and patients in cardiovascular clinical trials. All right. Thank you very much. It is a great pleasure to be here. I think we all know that this is an incredibly timely topic, and so thanks to Drs. Russo and Curtis for putting this together and for involving me. So I think I've been tasked to, I guess, set the stage, talk about where we are right now with the involvement of women in clinical research, both as patients, which is really important, as well as investigators. So I don't want to bore people to pieces with a history lesson, but I do think it's important to know how we've gotten to where we are right now. So this is a brief timeline of the involvement of women in clinical trials, and I highlighted a couple important dates. So one very important date is 1977. So I can't believe that's nearly 50 years ago, but it is. And in 1977, several very important things happened. One, the Belmont Report was released, which was the document that outlined the principles of ethical research. But another really important thing happened with regards to our purposes in 1977, and that was that the FDA issued guidance that women of childbearing age should not be included in early phase drug trials. And so this was really important guidance. It happened because of the thalidomide crisis, which I'll talk a little bit more about. And that guidance basically sat there until 1993. And we all know a lot of important cardiovascular research happened during that time. So in 1993, the NIH Revitalization Act was passed, which specified that women and minority groups should be included. And then also in 1993, the FDA specifically rescinded that guidance that said that women should not be included in those early phase trials. But obviously, change does not happen immediately. So for the younger people in the group, thalidomide was an anti-emetic, and it was an anti-emetic that was heavily marketed to pregnant women for morning sickness in the 1950s and the 1960s. So it was a very good anti-emetic, and it was also horribly teratogenic. And as a result, a number of women gave birth to children with very significant birth defects. It took them a long time to figure this out. It really hit the national consciousness, got a ton of press. And that is why the FDA in 1977 said, well, OK, one of the things we're going to do in response to this is not include women in these early phase clinical trials, particularly for drugs. And the idea was that this was protection by exclusion. We'll protect these women by not involving them in the trials. The men will be the ones investigated. But we all now recognize that the result was neglect by exclusion, because the women weren't being studied. And if you really want to put a fine point on it, we're essentially treating women as post-marketing guinea pigs for drugs and devices, right? Because if they're not being investigated after these products and drugs are being labeled for market, they're still going to get used in women. So for the people who thought this was a good idea, the reason they think this is a good idea is, and not to be too crass, they're essentially viewing women as small men with uteruses, right? And so the idea was, well, we'll study these drugs, these products in men. If they're safe in men, then they'll be safe for women. We protected the women by not including them in the research. We all know this isn't true, right? There's a lot of differences between women and men. Biologically, there's chromosomal differences. There's sexual hormones. Women have different body habituses. And then, of course, all of those intersects with the sociocultural factors and the socioeconomic factors. And so the bottom line is women are not just small men. Women are quite different. As a result of this and other factors, women essentially have been subjected to disparity as far as cardiovascular care. I would argue a lot of that starts with the underrepresentation of women in clinical and preclinical studies. This leads to lack of prevention and awareness. We have inaccurate risk models that are not appropriate for the different cohorts. And it's important to note that what information we do have from research about women is predominantly going to be in white women of middle or higher socioeconomic status. And so there is cardiovascular risk amplification in intersectional women, which is really important to understand. So this all started with protection by exclusion, but I think we all recognize that that's probably not the only reason that women have historically been excluded from research. The bottom line is it takes more effort to include women. There are issues about fertility, estrogen cycles. One interesting factoid is that for basic scientists who do work with mouse models, they oftentimes use only male mice for this reason. So I guess the sexism is not limited to human beings. Investigating men's health is historically prioritized. So the Physician's Health Study was a randomized controlled trial evaluating aspirin and other preventative measures in men. This is the trial where we got that information that aspirin was good for prevention. Going on at the same time was the Nurses' Health Study, which was the female equivalent. And that was just an observational registry trial, so the women don't get the expensive randomized controlled trial. And one interesting factoid, the first study that anyone ever did evaluating estrogen and cardiovascular disease was to use it as a therapy to treat men, which I think is particularly noteworthy. All right, so a review of 325 cardiovascular trials from 1997 to 2009 in three major journals showed that only a third of the trial participants were women. And when they accounted for disease prevalence by age and sex, the representation was even worse for women. So for example, something like pulmonary hypertension, where there are more women compared to men, there were more women included, but not proportionally to what you would have expected. In an analysis from 2010 to 2017, there's some improvement, but it's mostly in trials for conditions that affect women more. As a result of this, we have a huge gender knowledge gap. So women across the board are twice as likely as men to have drug side effects. And I don't think this is surprising, right, because women are smaller. They do have different body mass composition. Women are more likely to have bleeding complications from thrombolysis therapy. Women are more likely to have complications from PCI. If you look across all populations in the United States, African-American women likely have the worst cardiovascular outcomes of any single group. And specifically for EP, when we talk about ICDs or AFib, there's just a lot we don't know. So when it comes to atrial fibrillation, again, women are not the same as men. Women have lower prevalence compared to men, but women live longer. So if you look at the absolute number of patients with atrial fibrillation, there's actually probably more women than men. Women are more symptomatic. They have a higher risk of stroke. Their anatomy is different. They're more likely to be treated with rate control compared to men. They're less likely to be offered aggressive therapies. And when it comes to catheter ablation and left atrial appendage occlusion, they're probably likely, at least slightly, to have more complications. This starts to get really complicated, and this highlights why it's really important for us to study different groups of patients. Because now we have the intersection of gender and age. So this figure is essentially showing the prevalence of all cardiovascular diseases by gender and by age group. And you can see what happens is, as the patients get older, women are more likely to have cardiovascular disease compared to the men. And so when we talk about complications from different therapies, like AFib ablation, or not being offered aggressive therapies, how much of it is biased? How much of it is the patients are older and sicker? And again, we don't entirely have the answers to those questions. So if you look specifically at women in atrial fibrillation ablation, this was a registry study, but a very large amount of patients. And in this study, the women did not do quite as well as far as survival after their initial catheter ablation. The women were older. They also had more comorbidities. They had slightly more procedural complications. And then again, we have this paradox that the women were more likely to have atrial fibrillation hospitalizations after their ablation, but they were less likely to receive repeat ablation or cardioversion. This is a nice figure looking at women in ICD trials from doctors Han and Russo. And this highlights what we know about ICD therapy in women compared to men. So the women are older. They have more comorbidities, but they also have more severe heart failure at enrollment, which implies that they're being referred later than the men. Probably more complications from transvenous ICDs, less likely to be referred for an ICD if they meet guideline indications, fewer appropriate therapies, and they may have less mortality benefit. This is another figure also from that paper, and they did a nice job here of outlining all of the different ICD studies and then broke it down by male authors, female authors, and female participants. Not surprisingly, in the very early secondary prevention trials, there are no female investigators at all, and the female patient enrollment is quite low. With the primary prevention trials, we have some female investigators. The highest is in SCUDHEFT at 35%, but the female enrollees isn't a whole lot better, with the highest being 29% in amniovert. So none of these trials even got to a third of women participants. So I'm not going to, this is obviously a busy figure, but it highlights the complexity of getting more women into these trials. Of course, the piece we're talking about right now is the clinical trial infrastructure, particularly with the underrepresentation in study design and leadership. So this was a paper that was looking at women cardiovascular researchers looking at trials from 2014 to 2018. They were showing two different studies here. And you can see, if you look at all trial types, the best we could say, potentially, is 10% of first authors are women. If you start looking at procedural studies, it goes down. And if you look at very large studies with more than 500 participants, it also goes down. And then if you look at female physician representation on the leadership committees, it's extremely low. This is looking at women who are investigators in heart failure trials. And sort of the blue area is median total number of authors, which you can see is slowly going up between 2001 and 2016. But when you look at the medium number of women authors, not a whole lot of change. But the reason I wanted to include this is because of this figure. So this is looking at the proportion of women authors versus the proportion of women enrolled per trial. And what you can see is, when they controlled for all other factors, basically the only variable that correlated with enrollment of female participants was having female investigators. So this is another paper looking at temporal trends in women cardiovascular researchers. And again, this is from 2010 to 2019. And you can see not a whole lot of change in women PIs. But again, look at the second figure. If you look at the mean percent of women patients recruited, if you look at the male PIs, it's in the low 30% range. If you look at the women PIs, it's not quite to 50%, but it's a whole lot closer. And it was statistically significant. So from that paper, 18.4% of studies were led by women. We appreciate our industry sponsors today, but the reality of the matter is, in this trial, the NIH studies were twice as likely to have a female PI compared to the industry-sponsored trials. Arrhythmia-related trials had the lowest number of women leaders at 10.6%. Women were more likely to head nutrition and rehabilitation trials compared to drug or device trials. And this is from a very simple letter that was sent by Minow Walsh to one of the Jack journals several years ago. And what she did is she looked at one of the ACC scientific sessions. And she looked at the late-breaking clinical trials and featured clinical research sessions. So these are the big trials, right? These are the ones that are the lead trials that everybody is wanting to go to. And she basically said, what is the women's involvement in these trials? And so there were over 40 trials that were presented. There were 16 chairs. Of the chairs, six were women. So not terrible, especially when you consider the overall prevalence of women in cardiology. If you look at panelists better, but look at the presenters. So who are the presenters? The presenters are the lead on the trial. They are probably going to be the first author on the trial. Out of over 40 trials, only three of them were actually presented by a woman. And the three trials presented by women were arguably about female-centric topics. So one of them had to do with cardiovascular outcomes after breast cancer therapy. One had to do with workforce issues in the era of COVID. And so the implication of this is that women are really only being considered to lead these trials when they are about things that are viewed as being women's topics, forgetting, of course, that all of these other trials that are being presented almost certainly have a great deal of importance for women as well as men. And I would argue that this figure kind of sums up where we are as women electrophysiologists right now. We're here, and people seem to recognize that we're here. And they seem to recognize that we are contributors and that we are important. And they want our involvement. But this somehow isn't quite translating into us reaching the upper echelons of leadership, particularly when we talk about issues regarding research. And just as a reminder, this isn't just about us, our careers, or us getting ahead, although there's nothing wrong with that. Our careers do matter, and we have every right to get ahead. But this also does matter for our patients, because if we increase diversity in clinical trial leadership, then that leads to increased enrollment of diverse population, increased generalizability of our findings, answering all these questions that we don't really have the answers to right now. And then, of course, this does improve our careers. And this becomes a cycle that not just benefits us, but benefits all of our patients. And I will stop there. That was great. Thank you, Pam. That was terrific. We're going to move on now to Jeannie Poole from the University of Washington. And we had performed a pre-summit survey of women with their clinical trial experiences among women EPs. And Jeannie's here to give us the results of that survey. Thank you, Anne, and thank you for really making this happen. When Pam was showing her timeline slide, I started EP when that public health task force decision was made to enroll more women. So actually, I sort of have seen this from the very beginning. And a couple of things will come out. But to that point, I wanted to say that I was fortunate. I landed at a University of Washington hospital, which is where MediQuant started, with a fantastic, brilliant clinical trialist named Leon Green, which many people don't even know. But he was the co-PI of CAST, the PI of the AVID trials, the PI of the David trials. So thrown into this milieu of people who do clinical trial work. And then Gus Barty came, and Scott Hefton, and all that kind of stuff. But I think that kind of comes out in the survey and can also be potentially countered somewhat with what you'll hear from the panelists. So let me just click away here. All right, so this survey design was to evaluate women across academic and non-academic institutions, to evaluate their experience in clinical trials, to identify obstacles to participation and leadership, to identify a needs case for an action plan development. The survey was sent out through the HRS email platform, and the women in EP list serve. There were 2,100 potential individuals that could have answered the survey. And typical surveys, we have 80 good, solid responses. All right, how about if we click there? Click there, OK. So on this slide are kind of the demographics of the individuals that answered. So here are years in practice up on the left upper pie chart. And you can see that the majority were individuals who had been in practice for a while. So 60% greater than 10 years, 20% greater than five years, and only 25% of them were younger than that. Most that answered the survey were actually practicing in an academic hospital, 9% private practice, 9% non-academic, and then a small percentage that were retired or in the in-string. Pop up to the right corner, right corner, you can see that individuals outside of US made up 33.75% of the folks that answered this. And the top two countries were Spain and Japan. And of the United States, the majority of respondents were from the East Coast, Southeast, or Midwest. If you look at the bottom bar, type of practice, over 50% had a pure clinical practice, 35% had a mixed practice of research and clinical, and only 4% were research only, and 6% were other. Work effort, most were working full-time, 85%, some of them part-time, and a few were retired. Looking at the pie chart below, this was the institutional rank, if individuals were working at an academic institution, and you can see it covers the sort of usual spread of assistant professor, associate professor, full professor, semi-emeritus. But what I thought was particularly interesting was this 20% of individuals who worked at an academic hospital that does not have any promotional tracks available. I don't know what hospitals that would be, but maybe others do. Now here are some more questions about the institution. Does your institution participate in multi-center clinical trials? In the left upper corner, the bar graph there, yes, 90% of them do, and so the next question is, in what ways does your institution participate? And you can see that the green bar is that they participate, 55% of them participate in industry trials, 32% or so in nationally funded trials, about 70% have participated in both types, a small percentage, under 30%, actually have been a coordinating center, and 30% have a clinical trials unit. Does your institution provide protected research time? I mean, this is a biggie in this day and age with RVUs and everything. So 32%, no, investigator must fund their own research time. 30%, 20% had answered yes, but it depends upon the academic track. Some said both, some said none of the above. The none is discouraging, because that's about 25%, again, despite having institutions appearing as if they are involved in a lot of research. What type of research funding are the individuals familiar with? Well, they were familiar with everything, industry-sponsored trials, national-type trials, institutional trials, foundation funding, and a small percentage were not familiar very well with any kind of funding. Next question, how have you, as an individual, participated in clinical trials? Well, the largest numbers were these three blue bars that extend the further this, so this was being a study PI or co-PI for an investigator-initiated, industry-sponsored trial on the top blue bar, so over 40%. You drop down to the site PI, which is the next long blue bar, that was almost 47% or so had been a site PI. And then participate in patient recruitment was very high, that was the third long blue bar, almost 50% had participated, at least in recruiting of patients. And then you can see the fewer people participated in nationally-funded trials, it's the third bar down, and that's about 32%. So if you don't participate in clinical trials, the question said, what are the reasons? Well, the biggest reason there is lack of opportunity, so that's really important when we think about this. These were individuals that, by and large, work at academic institutions, yet there's lack of opportunity. Another is just personal decisions in the orange, institutional priority, it's not an institutional priority in the green, and a small percent are just not interested. We looked at a couple other indices of being involved in clinical trials in terms of being a participant on NIH study sections, so yes is the green, no is the blue, and that's not particularly surprising because it's only a small percent of people that actually, over time, can get into those study sections, but you'd like to see that higher. Or being on a DSMB for NIH or PCORI grants. It was more likely that individuals were on an industry advisory board. So the next question is, well, what kind of training have you participated in? So these are the options. Up here in the, I know my arrow doesn't work, but up there on the right, the master's program, you can see that there are some. So maybe about 13, 14% have taken a master's degree of some sort. Very few have availed themselves of what the ACC. So kind of going clockwise here, institutional workshops. The largest was the certificate programs, but another large chunk in the magenta is they haven't had any kind of training whatsoever, or had the opportunity to be trained. So what institutional barriers have impacted you? So lack of funding in the red is one of the major ones. That's over 50%. The other big red one is no protected time. And honestly, those are the two big challenges. It doesn't matter whether you're male or female to do clinical research in this day and age. But coming down the bars now, leaving the top red one and going down to the blue, it's not an institutional priority at 30%. It's the institution primarily focuses on clinical priorities, almost 40%. Opportunities are not advertised. That's a problem. That's something that could be remedied. Lack of clinical infrastructure at about 37%. And then dropping down to no mentorship right below the second red bar is about 32%. No mentorship at all, that's discouraging. But in green, 30% answered I feel overlooked for opportunities compared with my male colleagues. Okay, that's a lot. Only a small percentage at about 5% said I feel overlooked due to perceived racial or ethnic disparities. And a smaller yet percent said I have not faced barriers, which means that most people have faced significant barriers and multiples of what you see on this slide. So what personal barriers have impacted you was the next question. Not enough time, no knowledge, expertise, or experience. I do not know where to even start. That's discouraging. No mechanism to network or connect. And very few answered not interested or said they had no barriers. So what can we learn more about mentorship? So look at this. 60% have neither been a mentee or a mentor. Again, very discouraging. That's disturbing. If they had had any mentoring, they were asked, have you been a mentor or a mentee outside of your own institution? And 60% of them said yes. This question is on visibility. So the question was rate the visibility that you feel you have as a woman in your program with one being no visibility to five being great. So again, going clockwise around this pie chart, 7% said no visibility. 33%, only a little visibility. 28% said some. So the bulk of this pie chart is basically not a lot of visibility as a female in their program. And then 12% was good and a lot was five. So less than a third, certainly almost about a quarter felt like they had good visibility and the rest did not. And then finally we asked about aspirations. Would you want to be a site PI or co-PI? Or would you want to be a study PI or co-PI? So you can see that most answered yes, 60%. Yes, I would like to be a PI or a co-PI at my site or in a study. A small percentage, of course, had already had that opportunity. And only a small percentage said no, that I'm not really interested in doing that. So most would want to have that opportunity. So we also asked the participants to provide ideas for change. And there were a series of questions which I left off the slide because the answers didn't quite line up with what the questions were. But here are some of the comments that remain. Mentorship and support, emphasis on mentorship programs and networking opportunities. Second, institutional funding and opportunities, need for better funding and institutional support for women researchers. What about leadership and representation? Increasing the number of women in leadership roles such as principal investigators. And finally, cultural and perception shifts, recognizing women as equals in research and fostering an inclusive environment. So in summary, from this survey, most of the respondents worked in academic institutions. Common themes were lack of funding, lack of protected and funded time, not enough time. I mean, that's how we all feel. I mean, RVUs drive our lives, right? Epic Inbox drives our lives. It's not an institutional priority despite being an academic institution for a certain percentage of those that answered. And in terms of the personal questions, lack of mentoring, lack of visibility came out really loud and strong, and yet the individuals aspired to participate in clinical trials if given the opportunity, all the way up to the top as a PI or co-PI. So that's the end of the survey. And I think Uma Srivatsa is gonna follow me and sort of put together what I've talked about, synthesize it a little bit, and then you'll also have an opportunity during the panel discussion to hear about some of the initiatives going on at HRS that may address some of these issues. That was great, Jeannie. I think that really sets the stage, gives us some, I think some low-hanging fruit on next steps and things that we could do. I mean, opportunities, there are plenty of them out there, is how do we get them to women, and certainly there's definitely interest. So our next speaker is Dr. Uma Srivatsa, who is gonna talk about barriers to succeeding in clinical trials research. Thank you, and you can... Did you put them on? Hello, everyone. I want to thank Anne and Andrea and the rest of the team here for giving me an opportunity to speak on this topic of barriers to succeeding in clinical research. I'm gratefully borrowing some slides and some survey results from Jeannie Poole. And as she pointed out, one of the most important barrier among the clinical scientists is lack of opportunity. From the physician's side, that is a problem. And from the patient's side, fewer than 10% of the eligible patients are being enrolled in clinical trials. And in cancer, about 5% of the patients. And there are consistent barriers at every level and will go through them. And I've put together a 6C framework. First is clinical, related to patient volume, eligibility, expertise. Second is cost, direct and indirect expenses, connections, collaborations, mentorship gaps, center institutional bottlenecks and barriers, clock, time limitations and burnout, and crises, pandemic, geopolitical, and natural disasters. So looking at the clinical barriers, low patient volume or narrow eligibility criteria reduce the enrollment feasibility in any clinical trial. And if you consistently have that problem at an institution level, the institution may not encourage us to participate in clinical trials. And lack of specialized clinical expertise or infrastructure, like, for instance, gene therapy or advanced electrophysiology techniques or advanced statistical techniques may not be available. Patient distressed or provider distressed, referral distressed, can be a problem. And sometimes in rural center, there may be eligible patients, but there is no electrophysiologist to enroll patients in arrhythmia trials. So just looking back in history, some of which have already been addressed, there are many clinical trials have been terminated for various reasons. And majority of that is because of uncertainty of clinical result or unpredictability of clinical outcomes may be a deterrent to enrolling patients in clinical trials. So other enrollment challenges, there can be slow enrollment, as happened in AIM-HI trial. In reverse trial, there is skepticism, hesitation from referring physicians. VEST trial, because of discomfort and stigma from wearable device. Sprint mind trial, which was really a cognitive outcome in hypertension, the cognitive testing burden was huge. In ISOR-REACT-5 trial, the clinical complexity of the design was high that there was a high dropout rate. In rehab, HF limitations because of the patient population functional mobility was a problem. In my own experience, I got some funding for studying meditation in a ICD-CRTD patients only to realize the Medicare population who is eligible for it were not interested in meditating. So slow enrollment has also, Jeannie Poole can speak to this more about the SCUD-HEF trial. So there was initial slow enrollment because of strict criteria, and then they had to modify it. Similarly, cabana was a problem because patient preference was to have an ablation. Now the REACT-AF, the technology has been an issue because only Apple users can be enrolled in the trial. And there are quite a few people who are non-Apple users, and majority of them are Medicare population, and utilization of an app is a problem for them. And in my own clinical study from the OSHPD database from California, I mean, there was a problem of referral, actually. Patients or referring physicians didn't believe in ablation. Yes, it still happens. So the next moving on, cost constraints. So direct costs, regulatory submission, study coordinators, data collection, lab tests, and device implants are a major direct cost. Indirect costs, mainly the opportunity cost of reduced clinical productivity, besides other indirect costs that is related to high academic institutions. And then majority of the time, we want to initiate a study. We want to do a pilot trial. Who funds that? That's a problem. And then NIH R01 may not necessarily cover coordinator or a startup fees, and institutions may not cover that as well. And as such, academic physicians don't get paid much, and we have to cover the cost. And then next is the device cost. If it is an expensive device to implant, the insurance frequently potentially denies it as a experimental device. Moving on to connections, and Jeannie spoke a lot about it, a lack of opportunity. And majority of the investigators are in the junior, early, or middle career faculty members. And so the lack of interdisciplinary teams, like engineering or cardiology for device trials, or there may or may not be industry connections. And my experience with industry is that you have to have a lot of patient volume for them to want you to be a member of that clinical trial, number one. And second is they hate it when they have to deal with contract negotiations with an academic institutions. Sometimes it takes up to six months to nine months. And I was participating in a cryopivotal trial. Medtronic had a Medtronic versus UC Davis. We never won. So the other aspect of it is mentorship. Early career researchers may lack the mentorship or collaborators. Multi-center trials often need pre-established networks. So joining a consortia or institutional interest groups might be of benefit. There does exist AFIP consortium or VT club right now in our own society. However, only well-known centers are really participating in them. So smaller centers, intermediate centers where people are still enrolling patients are not yet participating in many of these important research collaborations. And institutional barriers can be, again, as I mentioned, about the contracts. Industry partners look for faster onboarding. And then IRBs may be slow or inconsistent, especially if we are participating in multi-center trials. The investigators can be pretty frustrated, and they may lose out an opportunity to be a part of the clinical trial. And then lack of research culture or protected time for faculty. I mean, there are many academic institutions, including mine. Many of them pay lip service for wanting to be academic centers and research centers. And also, limited access to core services, especially statistical management, biobanks, et cetera, can be a problem. And some of them also lack centralized infrastructure like CTSC, CRUs. And then time is the biggest problem for us. So we are caught between time required for getting training, compliance, patient consent, documentation, which are frequently not taken into account. And our procedures generally take a long time or unpredictable time. PFA has changed a lot. But still, if we take a VT case, you don't know when you're going to come out. So the clinical productivity metrics may disincentivize research. And faculty often have less than 10% protected time for research. And then burnout and administrative fatigue limits the willingness to pursue research as well. So besides all this, we are facing huge crisis now. So pandemic was a big deal. Over 1,200 clinical trials were paused or terminated due to COVID-related constraints. Staff were diverted to patient care. IRBs prioritized pandemic-related protocols. And then natural disasters, which are unforeseen, can happen frequently. In my part of the world, earthquakes, fires, floods, nuclear disasters, hurricanes in Southeast, wars. In Europe, we have published a water-related paper in Hot Rhythm O2 Global Voices section. And we always are looking for outside papers. But the problem for getting manuscripts from international research scientists is all these disasters that we are encountering. And then, of course, now we have the NIH crisis. The current administration has proposed substantial reductions to NIH budget, suggesting a cut from $48.5 billion to $27.3 billion. And it also plans to consolidate 27 NIH institutions into eight. And there is a freeze of NIH grant funding, which was implemented on January 27, halting consideration of new grant applications, delaying funding decisions for various research areas, including heart disease, cancer, and Alzheimer's. And NIH announced a cap of indirect cost payments at 15% of the grant value, down from a typical 30% to 70%. And in that, the indirect cost is also higher in academic institutions compared to private institutions, which has been a problem for academic institutions to start with. And then there are also termination of programs for HIV and LGBTQ-related research as well. So the politics and the policy ongoing political gridlock and funding delays have resulted in slowed grant reimbursement to our new studies, delayed peer review cycles. There are a lot of people who have been laid off from NIH, and forced many investigators to operate under budget constraints or temporary no-cost extensions. We have had to lay off graduate students, and postdoc admissions have been limited. And research faculty have been redirected to clinical work. And one of my colleagues who has 80% funding has been redirected to do 50% clinical work. So I just wanted to put it in a different perspective, because I love the business of medicine. So if you look at research as a business, the initial investment, which is the cap X in the business term, is equivalent to the study startup costs, equipment, and staffing. And the operation costs are equivalent to investigator payments and follow-up visits and the other costs related to indirect and direct costs. The project cash flows are the research milestones, publications, and IP gains. The project duration in the business is equivalent to enrollment, treatment, follow-up, and analysis. And the net present value, or the rate of return, is equivalent to the return of investment from funding, commercialization, and impact of clinical research for our patient care. And how is this delays affects all this? So NPV, the net present value, is reduced because of value of benefits and savings declines. And so the delays in clinical research not only affect the timeline, but also the strategic and financial outcomes. And the payback period, which also increases the investment recovery for the clinical research, takes longer. The total cost increases because of all the factors that I mentioned about. And then strategic return on investment is also lost because if you have a missed chance and we lose a competitive edge on a clinical research, somebody else comes up with a similar idea, all your years of hard work is gone. So planning ahead for budget implications, project prioritization must consider timeline risk. Implement scenario modeling trial budgets. What's the best case scenario? What's the worst case scenario? Or medium case scenario? Or consider sensitivity analysis. That means that if you change one aspect of the clinical, if you change enrollment problem, if you change outcome problem, if you change loss of faculty, how would you handle the clinical research? And then explore adaptive designs or centralized recruitment to mitigate risk of clinical trials. So budget with buffers, incorporating timeline risk premium to ROI calculations, evaluate ongoing trial delays, and decide on early, I mean, SCADHEF was very successful in that, early change in directions. Use centralized monitoring to proactively manage site performance as far as DSM is concerned. And all those can be very, very helpful. And then international barriers for both multi-central trials as well as for publications. As I mentioned before, now the tariffs and trade wars are a problem. International trials also face delays in participant recruitment. There can be export restrictions, visa complications for investigators, data sharing compliance problem. In Europe, we have the general data protection requirement, and US has different requirements. And the loss of individual countries can also be a problem for clinical research. So proposed solutions, we'll have small nonprofit organizations. We are doing pilot funding. And if they can increase pilot funding for early investigators, that would be helpful. Research mentorship, advancing research mentorship, both to early and mid-career personnel, shared resources among different institutions, and also protected time. Trust the faculty that they will actually produce and not worry about their wasted time. And research cannot be a hobby. It's actually a full-time job. So what's our institution going to do to remove the barriers? And how can we collectively make research not just possible, but actually prioritized? It's something we all need to take a look at. And I want to finish with my journey. When I joined UC Davis, we had only a 50% FTE. And we had only SVT ablation, spacemakers, and ICD implants. This was in 2005. So I had to triple the clinical volume in order to even consider enrolling patients or collecting data for research. And then when we hired EPs, they were only interested in clinical work. And then we founded an EP fellowship with the hope that we'll have EP fellows who are interested in clinical research, but they wanted to go into practice. So I started looking outside university. I started making connections with my own internal medicine department, data science, laboratory, translational departments, and started working on publications, which led to trainee grants, donor grants, industry grants, and now finally an NIH grant. But it's been a long journey. After 20 years, I'm able to land and speak here as an investigator. So lose no heart. There is hope. Thank you. OK. Well, thanks to our three speakers for setting the stage. Next, we are going to move on to a panel discussion. And so I think for the sense of having space, we can let the panel come up and relieve our speakers. Or if you want, if there's room to stay, you're welcome to. But feel free to sit in the audience instead. OK. Yeah. So what's that? I'll introduce you. Then you can introduce them. OK. So the panel discussion is about the current state of participation and leadership in NIH PCORI, industry-sponsored trials, and investigator-initiated trials. And our intention was to get a broad range of experience here to talk about the current state. Our moderator is Rachel Lampert from Yale University. Thank you, Anne. And thanks for the opportunity to speak and to have such an important symposium. I'd like to start by introducing our panelists a spectrum of types of practices, as Anne mentioned. So I'm going to introduce everyone. And then the format for the panel is I'll ask each of the panelists to talk for a few minutes about their own experiences. And we'll then open, guided by some questions, and we'll then open the floor to anyone from the audience who'd like to ask questions to the panel or the prior speakers. So our panelists today, we have Dr. Patty Tung, who is an assistant professor of medicine at Harvard at Beth Israel Deaconess. We have Dr. Kamala Tamarisa, who works at Texas Cardiac Arrhythmia Center. Dr. Ken Bilchick, who is a professor of cardiovascular medicine and the director of EP research at UVA and is also the chair of the HRS Research Committee. And Dr. Valentina Katifa, who is a professor of medicine and the vice chair of clinical research at the University of Rochester. So what I'd like to do is start with Patty, as I think our most junior member, maybe. Patty, tell us about what types of research you've been involved in and kind of how you got there. I don't think we're hearing you. Is this on? Is that better? No? Are they on? Is that better? Yeah. OK. So hello, everyone. Patty Tung, thank you for organizing this and sponsoring this panel. So my experience in organized clinical research has been as the site PI for a couple of drug and ablation trials, some of which were pre-approval and some of which were post-approval. So my first trial that I was the site PI for was the opportunity was offered to me by a senior member of the division. Industry had approached him, and he offered me the opportunity, which was very nice and very welcome. This was a drug trial pre-approval, and it was inhaled analog of a calcium channel blocker for SVT that some of you may be familiar with. And I think a lot of Uma's points that she made about things that set you up for success when you're sort of taking this on were very true in this case. So it was fairly easy to enroll for the study because it was permitted to enroll people even if you were planning to take them for ablation. So it was, you know, I think it was an analog of a medication that we were already familiar with and so it didn't feel so experimental. And so we were able to enroll a lot of patients. And that was helpful to me sort of to get my feet wet and also for the institution it turned out well for us. There were also a couple of kind of fits and starts as Uma mentioned as well. Things related to trials shutting down during COVID or just kind of not making it through our own institutional IRB process and regulatory process. And, you know, I think there's not that much you can do about that but just know that there will be other trials that do make it through the process. So I think more recently I was involved with first a post-approval study of the Tacticath catheter. So for those of you who are familiar, it's a radiofrequency catheter and the FDA mandates that industry conduct post-approval trials, right, of different products. And so we were one of the centers. And we actually ended up being the highest enrolling center in the trial which was very kind of gratifying and it turns out that, you know, having high enrollment and doing well in a trial kind of affords you some access to the publication committee and other meetings related to the trial. And I think based on that experience, we were then asked to be one of the sites for the pre-approval trial of this company's PFA catheter. And, you know, there were some challenges, again, that Uma touched on where there was kind of a race to the finish mentality and it's hard for academic centers to compete with the same timelines, I think, as more private-based partners where the IRB process is much shorter, there's less administrative requirements. And so there were some discussions with the sponsor saying, you know, you're making it very hard for academic centers to have equal footing. And I think they, excuse me, they heard that, but it's just something to be aware of. In the end, we were able to contribute, you know, a good number of patients, not as many as I think we would have hoped and we asked for things like an extension or creation of a registry to be able to keep contributing because the concern was that actually the timeline was moving so quickly that we would have put in all this effort with our clinical trials office and going to the IRB only to find that the day, you know, you're ready for site initiation is the day they close the trial. So it ended up working out, but it was definitely a learning experience for me on that side. Patty, let me ask you a question. So you're fairly early in your trajectory. You kind of moved from a post-market to a pre-market. Where would you like to go from here as far as clinical research and trials? So we talked about this a little bit before and Rachel asked me, I was saying that I would like to be part of either steering committees or kind of more of the planning process for some of these large multi-center trials and she said, do you know how to get there? It's not really clear to me, right, how to move from site PI to more of the regulatory. Yeah. I think that's a question that I'm hoping the second half is going to answer for all of us, but I think it's so important. So thank you. So Kamala, let's move on to you've had a chance as a private practitioner to get involved in a fair amount of trials. How have you, how has that worked for you? How have you gotten to where you want to be? So private practice, you know, there are advantages and disadvantages, but this was years ago. I finished my fellowship in Ann Arbor and then when I decided to go to private practice, literally five to six years of, you know, setting up the program, started the AFib ablation program, built the program from, literally from scratch. And then I realized it took me six or seven years to realize that, you know, I'm not part of any research. I'm not contributing now that, you know, I had time. Seven of the other colleagues were all males and they've been there, but AFib was not a priority at that time. So I built the AFib program and then I realized that most of the industry sponsored research was going to the male colleagues. Number one, they've been in that space for longer. Maybe they had more visibility, I think, to, you know, the previous talks. But I had more visibility and, you know, I was newer, younger, and the only woman. And so I kind of, I asked a few times, I said, I'm interested in being a site PI for any of the industry lead-related trials and it took another few more years and then I reached out to my male colleague and I said, you know, you've been doing the site PI for a lot of studies. Is it possible for me to take a lead on a few of the trials? And he was kind enough to let me in and I think one of the first one was that intranasal, it was already marketed, the calcium channel blocker one, where he was the PI and for our site I was a co-PI. Then I went to, you know, most of the lead trials, the DX lead for the biotronic and then the left ventricular pacing leads for, you know, Abbott that became from unipolar to, you know, multipolar leads. And so slowly did research in there, I mean, just enrolling patients and making sure we had good enrollment as a group. And there was another group in that same place, which was a big group too. So I included all of them as co-PIs and so our numbers of enrollment were high. At some point, Arthur Moss, the RAID trial, the Renexa, you know, I was the PI, site PI, but, you know, Renexa, the trial didn't end up having a positive outcome. Nevertheless, so it took a lot of effort and basically putting, asking again and again. So the one lesson I learned is ask, you know, maybe a few more years people will say no, but maybe the third year, you know, they see the potential. So once, I think it was a positive reinforcement for me that we were getting a lot more teams, many more EP physicians to be engaged despite being in the private practice that we can enroll patients. And when I moved to Texas, of course, I have the, you know, luck or whatever you call it, I have the luxury of having Jodi, Dr. Hurwitz, as our, you know, are in the same place. So I have a lot of talk about mentorship and support. I have a lot of support. So, you know, I think that's very important for women to find a space to go keep asking. So lately we have enrolled patients in Aim Higher, FACT-CRT, and I will give a shout out here for networking, how networking is so important to Valentina. We just met at Women in EP, and it was an email saying, hey, would you have interest in enrolling patients for FACT-CRT? And so we ended up being one of the top centers that we enrolled patients together. And the Integra-D is the CCMD, we've already finished our enrollment, you know, the assigned number of devices for our center. So, you know, it took a long time, so, you know, persistence and having those mentors and the reinforcement in both male and female mentors is so important. Kamala, I want to take you back to something, to two things that you said. You said you started, you had said, you know, you felt invisible at first, and then eventually you became visible. And you also said, I asked and I asked and I asked. So who was it that you asked? Did you ask the industry folks running the trials, did you ask your mentor? Who did you ask and how did you get from invisible to visible? So, I mean, to be honest, the industry folks weren't listening to me because I wasn't visible. I mean, I was too small, I wasn't a big name in the field. And so it was my male colleague who literally I reached out to him and I said, you have a lot of trials, you know, could you share them with me? And so, you know, it took, and then the second turning point is Women in EP, the, you know, the company sponsored events, literally meeting all of my mentors, you know, going to them and saying, I'm interested in something. If you're doing a research, it's a multi-centered study, know that, you know, we can do enrolled patients and that's how Valentina invited us. Okay, great. All right. Thank you. So I'm going to jump to you to kind of talk to us too about what kinds of research you've been involved with and how you got started with it. Thank you. It's remarkable to me how consistent these surveys are about the needs and the barriers to research. Sunita Ferns, who was on our research committee for some time, I'm not sure if she's here, she led a survey that we did among early career faculty and trainees about barriers to engagement in research after graduation from EP Fellowship and remarkably, you know, very consistent with the presentations here, the top three, number one was mentorship, number two was insufficient resources, and number three was time constraints and this article is available in Heart Rhythm from the February issue, you can look at some of those things. But I think these are consistent themes in my own career when I think about my involvement in research. When I was doing my EP Fellowship, at some point, I thought about how I wanted to engage in research after I would finish and what kind of position I would want and I knew I wanted to have an academic medical position and I thought about cardiac MR, I thought, you know, I really liked applications of cardiac MR to Rhythmi, as I know we share that interest as well, and so I got some people, among them was David Bloomke, right, who's prominent in the NIH world for CMR and he was at Hopkins at that time and I remember I did, we would, some of us who were interested, we just, I'd just read with him between cases between, you know, when I was a fellow in the EP Lab and then I was able to, Kathy Wu from, was also a mentor for me at Hopkins and she provided some access to some data and we were able to publish a paper and that sort of spurred things on. So I'd say that, you know, that's the first theme, mentorship. When I started my faculty position at University of Virginia, I ended up doing what is, I think, not uncommon now, it's a Master's in Clinical Research where you, it includes a comprehensive curriculum about study designs and some statistics and ethical considerations and other things like that and I had the protected time to do that, so that's the time constraint issue, one of the other barriers, and that really helped me. I had some protected time for that and then that facilitated getting the K23, which then provided me with resources, so there you have it, the three things, you know, mentorship and resources and time constraints. Right now, my research is focused on applications of cardiac imaging, particularly with MR and artificial intelligence to improve arrhythmia care in our patients, make electrophysiology procedures better, help with risk stratification for treatments like ICDs, try to figure out which of those non-ischemic cardiomyopathy patients are really going to benefit from ICDs, things like that. And I think, for me, it really is a motivating factor that, in my career, it gives me a lot of personal satisfaction to have the opportunity to engage in these research activities and it's something I look forward to. Of course, I look forward to taking care of patients and doing procedures and improving their arrhythmia conditions and fixing their arrhythmias and things like that, but I also, for me, it's important also to make contributions, scientific contributions, and that led me to do what I call a mid-career master's in statistics a few years ago, which accelerated my knowledge in artificial intelligence and machine learning, as I was already doing a lot of statistics anyway. So the last thing I would say is that when we think about fellowship training, I think there's an important message to fellows who are already, I see our own cardiology fellows and I know they're overwhelmed. How many board exams do our cardiology fellows have to take? You know what they are, right? And so a lot of them are just looking for a light at the end of the tunnel. They want to get a job, have a family, and things like that, but one thing I've told them is that try to also think about the future and think about what's going to be driving you, what's going to be making you, in addition to helping patients, but something else. Is there something else that's going to make you really excited about your career and it's going to give you that really positive attitude, you know, decades into your career? And I think an academic interest, an area of academic expertise, whatever it is, however you choose to do that, can be really important in that regard. Thank you, Ken. Valentina, let's move on to you. You're someone who has really had enormous success and impact. You've worked with NIH, you've worked with PCORI, tell us about how you got to a point where you were able to write an NIH grant, a PCORI grant, knew that's where you wanted to go. Yeah, well, you know, it's interesting, I think some of you already mentioned that one of the first steps of getting involved in clinical research and clinical trials is participating as an enrolling site. And so that's also how I started back in the day. I actually come from Hungary, I moved to the U.S. about 15 years ago. But back then, I was actually a sub-investigator, you know, not even a PI, in a made-it CRT from that site in Hungary. And just as I think, you know, I think Kamala, you mentioned, we've been the number one enroller site in the world. And so I, you know, had the chance to come and visit the University of Rochester as a reward of, you know, that accomplishment. And I've just been very fortunate to be exposed to that incredible research group and then, of course, you know, I ended up joining them. So it's really been, you know, sometimes the styles have to align as well. But just remember that I think getting involved in clinical research as an enrolling site is an amazing opportunity to have that initial visibility and, indeed, you know, if you're doing well, I think that's going to be recognized. And it may take, you know, some time, but I think it's very worthwhile, the effort. And then I think there was another thing that some of you mentioned, is there's one challenge I think women face very frequently, is that we often don't ask for opportunities. So I also really didn't ask, you know, I never really asked to be a PI on a large study. But I had just great mentors, as, you know, Ken mentioned, and so I've been given the opportunity to do that. I've been given the opportunity of leading one of the major studies that back in the day I was enrolling, you know, as an enrolling site in Hungary. So I think just look for opportunities and really also network, you know, as much as you can and identify female peers, female mentors, and also male peers and male mentors as well. I think it's, you know, sometimes I myself surprised, you know, how open people are to really help you in any way they can and not really looking at, you know, male, female, or any of those things. So just feel free to, you know, kind of break down that barrier for you and walk up to anyone and ask them to get involved. And then the last thing I'm going to say, you know, when you get there, when you get the opportunity to actually lead a large trial or lead, you know, an NIH grant or industry funded grant, just really remember where you come from and try to identify and help other women as well. I think that's something that I really wanted and, you know, Jeannie and I designed the BioLibra study and we were looking for female investigators and, you know, it was not easy at the beginning, but it's just something that we made kind of the mission as part of the study. And I've been consciously looking for similarly, you know, female investigators and DSMB members and adjudication committee members in all of my trials, because I have seen that the contributions that, you know, women can make to clinical research are just as valuable and sometimes even more valuable. So just wanted to say, keep that in mind as well. Thank you, Valentina. Let's open the floor to questions from the audience, either questions for our panelists, if maybe the prior speakers or people have questions for the prior speakers. We have some microphones up here too. This microphone is very tall. I don't have heels on, which is terrible. But thanks everybody. was actually when one of my male colleagues gave me his Pegasus TINI 54 trial, because I was an unknown. And I feel like I come to these sessions about women's leadership and women in clinical trials and women in education, and there are not enough male allies here. And we know many times men will listen to men and not to women, and that's just a fact of the matter. So how do we get more male allies on board, number one? And then number two, how do we move forward with industry? Because I feel like industry wants to do this, I think, because I've been on some meetings where they do want more women involved. But how do we get industry to sort of listen and know that we're here and we want to work with them? Any thoughts from the panel, or Andrea or Anne? Yeah, I'd like to, particularly with the response to the last question about industry and opportunities to get involved, sort of equalizing the playing field, so to speak, I'd like to highlight some of the things that HRS is doing from a research standpoint and highlight some things that are happening later on in this meeting that I think are particularly relevant to the subjects discussed. One thing is, under the leadership of Mina Chung, we proposed a HRS research network. We've been working on this since November of 2024, and there'll be two sessions on Saturday about this, one at 945, which will be a panel presentation that Mina and I are chairing, and then there'll be a panel discussion at 1245 in the exhibit area, where we'll have an opportunity to discuss it more. This evolved from the proposal for an EP collaboratory back in 2022, which was mandated by the FDA, or at least suggested by the FDA, in order to facilitate more efficient approval of industry products, so that, in other words, industry would do the studies in the right way, obtain the right data that the FDA would need to approve them in an efficient manner. And it was modeled after the Heart Failure Collaboratory and the Valve Collaboratory. At that time, the board, for good reasons, decided that it was not the right time. And then what's happened since then is that Stanford, under the leadership of Pete Weiss and Paul Wong, Stanford Biodesign and Medical Device Innovation Consortium, MDIC has started the second version of that EP Collaboratory for early feasibility studies. And these are studies of new technologies that have higher risks because they haven't been tested. Often, they're associated with small companies and startups. And the focus of that second version of the EP Collaboratory has been to get institutional champions for these. You may have received an email from HRS inviting you to be considered as an institutional champion, if that's what you wanted to do, along the lines of what Debbie Nair does. And so we've been working with that on these early feasibility studies, as well as Academic Research Consortium on AFib Ablation Endpoints with an associated document. The research network will really focus on several things that are building on this now, which include multi-center research studies, probably starting out with registries, but then also with the opportunity to facilitate clinical trials by connecting investigators and industry, if not necessarily funding the clinical trials. But I think there will be focus on registries and opportunities for connections. And then there are some proposals that we'll discuss on Saturday about a biorepository, about a research network to facilitate data sharing. And then spanning also, though, the full gamut from basic science to translational to clinical. And then we also hope to really help with diversity of leadership in these studies. I think by giving people the resources to do these studies, that we can achieve this goal of giving women and equal opportunities relative to men to lead these studies, proposed studies that would be considered by a steering committee. And then HRS would then provide some infrastructure to do these. And then also, we hope to help facilitate some early career research. So help our trainees and early career faculty also give them access to these resources, help level the playing field a bit, and have that as a way to get them involved. So Kenneth, so if I'm just starting out in EP, I'm planning a fair amount, but feeling pretty invisible. My partners are doing their own thing. How would I leverage what you're talking about to get involved? How would that work? Right, yeah. What we envision is an organization within HRS that will have an opportunity for you to communicate your interests to the leadership for the research network and to propose a project to connect with other investigators to request some support for the project, data sharing. These days, particularly with AI, data is power. Data is currency. And so I think by establishing these biorepositories, whether they're for ECGs or MRIs or bullet tests, this will really create some important data sets. And then even down the road, if there's a question you want to answer that could be addressed with this data set, then that would be another opportunity. Thank you. Thanks. Just in addition to the EP Collaboratory, just to follow up on Janet's question, it's certainly a work in progress for the research network within HRS. A few of us are involved in the EP Collaboratory. In addition, there's a registry being developed by HRS for ablation. So that might be another source for proposals and getting some projects through a prospective registry. In addition, a few of us have been involved with talking with industry. Because I agree, the industry involvement is key, and especially if there's less NIH funding. And that might even be more key than ever in getting women more involved at different stages. And part of this and support for some of this is obviously from industry. Thanks, let's go on to some questions. and many very real barriers have been talked about. But one thing that wasn't mentioned is the internal barriers that women have. And I'm basing this on the fact that there was a study, not for academic involvement, but for what jobs women will apply for. And what came out of it is that women Thank you. Okay. Comments from the panel? Yep. Does anyone? That's a—could I comment, Rachel? Yeah. Okay. No. You brought up a very important point, because we just talked about the research in almost like a singular track or a silos, but the sociocultural and just how we are, you know, you know that you quoted some of the papers. Women wait for a perfect CV before they apply for a job, and that is something we need to educate and mentor, saying don't wait for a perfect CV. You're okay just as is. Knowing that the answer might be no the first time or the second time, but keep applying, you know, but just at least you're on the visibility range. And then the second thing, you know, in private practice, I'll bring this, is the RVU models. You know, I think it's trickling into academia, too, but the productivity model, you know, this is—research is one place where they need to bring in the TVU, the time to value unit. Every unit of TVU, you know, has to be an hour of research done, and it's still valuable, but it's not seen by the institution, so, you know, there's no room for especially women, because we know from the data in cardiology space that women make lesser RVUs than men. We have data. But the women make lesser RVUs because they spend more time doing other things, including talking to the patients and, you know, doing other things, but research is one of those that we as a systems—I would like to hear leaders, but, you know, institutions to make a time to value unit for research, because it is patient care, but thank you for bringing that up. Thank you. Emily, did you have a question? Yeah, I do have a question, and ironically, Janet was the one who inspired me to always wear sneakers at conferences, and here I am on my tiptoes, but—so I have one— Secondly, for many people on the panel, we heard about the benefits of being a high-enrolling site and what that did for your own career and how it sort of opened doors. I think as an actionable item, for those of us who do feel the need to be perfect before we apply for something or don't feel ready to do something, like a toolkit, like how to be a good site PI, I mean, I don't know that anybody teaches us that. Can there be a workbook or a session or can we teach that to not just women, but to men also? How to be a good site PI. It seems like that's a win-win-win situation, so maybe if we could put that on the list of things to do. I would love that. session, I have a question for you. You know, we know across the globe that clinical practices vary. We know that approaches and adherence to guidelines. We know patient usage also changes. Clinical trials are becoming more global. And there are differences based on politics and based on economics and based on ethnicity and race and other things that operate elsewhere. So if we want to truly build a global, dimensional-wide, unified gender approach, what do any of you think about what we should be doing internationally to grow female participation in clinical trials there? And I realize that's a hard question that you may not have all the answers to, but I'm very curious about it because of the growth of international collaboration on trials. Get more women need to be visible as role models. And the more we've shown, I think Pam had really beautiful studies showing women as PIs mean more women are enrolled as clinical participants and all those. So we need more women in the leadership titles and more women as first authors on executive documents. And more we make room for women to be visible, then it's easier for us to emulate or just be, I want to be her, I want to be like her. So I know I simplified. Thank you. Other, Jeanne, do you have a comment? Maybe one thing we need is shorter mics. Yeah. So I think it's appropriate that Sabine talked about Europe, but we were sort of eyeballing each other because I think a lot of the principles that we've been talking about are exactly the same that need to be done in other places. And we actually have a history of one of the women in EP programs that was really conducted by electronic support of that program is called Epic Alliance. And that's how many of us met our European colleagues. And through that coming together, we were able to do surveys. We did some studies together. We got women on the program and sharing sessions. And I remember when Carl Hines showed up at one of our sessions and was surprised that we weren't talking about pregnancy and women. No, we were giving science. We were putting together real sessions with women who had done studies and women who happened to be chairing the session. And it wasn't called a women's session. But you could talk about maybe what's happened since then because I do think it had an impact. I think it's actually great what we managed to do. This is a long time ago. So Epic, I'm looking at Andrea and a lot of other people who were there from the very first days. And that's how we met. And I think I have to applaud all of you because you managed to be the president of HRS. And there's been a female, let's say, flow of powerful, I won't say power grabbing, but maybe power grabbing in a very positive way. In Europe, we have not been that good. We have not been as good in putting women as high up and as visible as, for example, the presidency of a big association. There is now Cecilia Linde, who's going to be the ESC president. And Cecilia was one of our Epic alliance people. And that's, I think, 15 years ago, probably, in my kind of memory. So I think it's a matter of just steady and slow and continuous pressure that will eventually get us there. And in some systems, it goes a bit faster. In some systems, it's a bit more sluggish. And again, in Europe, the different European countries are very different. I think you could, again, Valentina could tell her Hungarian experience. I can tell her German and UK experience. It's very different. There are lots of women in the workforce. There are lots of people who are doing the work but necessarily not get the recognition. But it's so multifactorial. And it's going to be difficult to find a universal answer to that, your question. But I think we need to just others, or super researchers, or whatever. We all are, we are so diverse, we need to be like that. Collaboration, networking, and learning from each other. You know, some of what we're, none of these things move very well. One of the things, it reminds me of the beginning of my career, and I was one of these people early on in EP, so I started the program at the University of Florida, so I was the only one there. But I, you know, one of the things that we haven't said specifically, we've talked about industry-sponsored studies, but one of the conduits can be the local reps. And getting to know the local reps, now they're sales reps, they don't do the clinical research, but they can get you to the right people. And when I started, in my position, the university, the health system there, predominantly used one company's pacemakers. And the rep was scared to death he was gonna lose that, because I was, you know, trained with a different company's group. So he knew I was very interested in clinical research, so he knew if he got me clinical research, I'd keep using his devices. And that's exactly what happened. So he got me some, actually some good, it was sort of investigator-initiated work, but we did it and got published, and I started getting known in that area. And, you know, and even though the statistics said something different, I don't know why, I did Cabbage Patch, I did AVID. I was in those early studies. And again, it was by, you know, you gotta be your own advocate. I opened up my mouth. Cabbage Patch, I wasn't at Columbia anymore, but I knew the guy who was the PI there. And I made sure, through guidance, it got back to him that I was interested in doing it, and he let me be a site investigator. I got to co-chair one of the committees that we talk about that you wanna get in. I got to know David Canham that way. And that was the first, you know, entry point into doing clinical trials leadership that then started to add as I went along. So, you know, don't, you know, minimize that. I mean, you've gotta get to know people. And again, you know, the sales reps are not, you know, are different from the others, but my district manager helped me in the area. And then after you get known, you don't need them anymore. You know, I mean, that's a good thing. I don't, I'm not, you know, disparaging them. But it then starts to take off on its own. Use every connection you've got to get involved in these things. You know, I'll just bring up something about asking for help as well, or asking to get involved. My research career has been a little bit different. I do a lot of research, not so much clinical trials, more investigator-initiated. But one of the things that really got me started, I do research around athletes with cardiovascular disease. And I went to a lecture that Brian Olshansky gave on this topic. And afterwards, I went up to him and I said, well, what about if they have ICDs? How are we gonna figure this out? And he and I then did a survey together, But so don't be afraid to ask. You know, I think that really is a big part of it. Go ahead. I was just gonna make a comment about, I think, another benefit if you're interested in being an enrolling site for industry-sponsored trials is that, you know, what your industry partner really wants is for a site to be successful in enrolling. Right, so if you can demonstrate that, in some ways, that's, I think, one of their top priorities, sort of more than any other. You know, whether or not they see themselves as allies or advocates, I think it carries a lot of weight if you show that you're able to enroll people and work with, you know, partner with them. Go ahead. I hesitated coming up here, but I heard industry a couple times, and so I felt the need to share some insights from industry. I lead the clinical research group at Cordis. And so sharing some insights, but also a question for the panelists. The insights I wanted to share was, one, how do women get selected as PIs, right? European regulators now have initiatives where they are actually demanding a percentage of our PIs and or investigators be females. So we're continuing to work with them. We're not there yet, but I think it's comforting to see that it's recognized from the regulator's side. So that's one. Second, in terms of global participation, many of our programs now are getting global, right? Getting through FDA's approval process versus European approval process. Obviously, one's faster, one's slower. So we're trying to maximize our research by global studies. And so when we do that, once again, I think there are so many opportunities there that we select a PI and a co-PI situation, and we make sure that there's a demographic balance between them. Now, the question I had, the thing that resonated, Dr. Poole, you mentioned quite a bit and others, in terms of mentorship, lack of mentorship. So if I were to take away anything from here, what does that look like? I heard the what, but is there tidbit that we can help bridge from industrial perspective in terms of mentorship? Programs, I mean, we do a lot of fellowship. We do a lot of, we invest a lot in fellows. We invest a lot in those educational programs. But what I'm hearing from you is lack of mentorship in women to conduct clinical trials. So is there a roadmap that I can take away? You know, I'd actually like to get back to your first point about the regulators requiring certain percentage of site PIs being women. I think you were talking about Europe, and I think in our country right this minute, we're probably not heading in that direction. So what can you as private companies do to set those expectations yourself? So I sort of put that back and say, it would be great if our government would do that, but right now, probably not. And so each company could perhaps say, we know as, I forget who said that, that things go better when there's a mixture of people on a board, on a whatever, a committee. We know that diverse groups get better outcomes. And so I would ask you as industry private companies to say, let's recognize that diversity improves outcomes and move forward with that, both because diversity in itself is good, but also because perhaps it will increase your bottom line. From the FDA's perspective, I think my personal experience most recently, what I would say is we have initiated those conversations with the agency. And as you may all know, when we develop our protocols, right, there's women of childbearing age as one of the exclusion criterias and certain standard ones, but then they also want diverse patient population. So using that as our catalyst, we've also lobbied for including women PIs. And I think they're getting there to your point. They're not there yet, but we're trying. Great. Just to follow up what Rachel asked, I guess, can you as industry, as a leader, just say we're gonna have, you know, Absolutely. 50%, you know, or whatever number that might be more than it is now. Yeah, FDA usually doesn't stipulate, to be clear, right? They just give you the number of sites that you need to enroll. And Dr. Tang, to your point, right, at the end of the day, fast enrollers, good patient population, we're looking for good data for faster approvals, bottom line. They don't stipulate men from women. So it's literally on us as leaders to select the right sites and independent of gender, really. Thank you. Thank you. Thank you for, also, thank you for sponsoring this symposium. Thank you, as well as for your comments. Rachel, can I comment on the program? So there's a program director's town hall. I imagine Pam's gonna be there, of course. And Jim Chung gave us permission to talk about an initiative that we have on the research committee to figure out this roadmap for mentorship during EP fellowship. I think in Sunita's paper, having research blocks during your EP fellowship was a predictor of if you would have the opportunities and the will to go on further. But it's challenging because now we have a two-year EP fellowship. There are a lot of procedures to learn, new procedures. But if you work in those research blocks, and you might think that that would attract mentorship during that time. So there'll be A.J. Rogers and Jose Huizar will be talking on our behalf, presenting some of our ideas for an initiative and a program director survey about how we could do it better. Again, here we go. You know, the comment that we didn't really discuss very much was about, there are very few men in this room. And it just doesn't seem to, you know, it's something that we feel passionate about, but we appreciate those who showed up. But there are not as many here. I don't really know what the answer to that one is. It's a really tough one. Because we've all had the experience, I mean, Rachel's been a leader with this too, of seeing major conferences where the representation of women faculty was either non-existent or so tiny, it was ridiculous. And when we bring this to the attention of the male organizers, most of the time they're shocked. They didn't even notice. They didn't even see it. And so it's that lack of recognition, you know, they're not even seeing it. And you can't fix something that you don't recognize in the first place. So whether it's that we have to just keep pushing that, I think some of these initiatives that industry's talking about, that the FDA is saying, we know that diverse groups do better. And by asking to have a better representation there, force people to find very well qualified women to do these things, right? I mean, it's about having the best qualified people, but having them be, you know, diverse representation is better. As particularly for all the reasons Pam said it very well about getting more female patients involved in clinical research so that we know those answers. So I think that's an ongoing issue. I don't know all the answers for it, but it's something that we definitely have to keep reminding the male colleagues who are not in this room today. You know, I think on the individual level, we all have had wonderful male mentors. I think each person mentioned a male mentor. I know, Anne, you mentioned David Canlam, who just was an enormous mentor and sponsor for me. And I think we could all point to men, but in our lives who have been so wonderfully doing mentorship. But I think it is the more systemic, systematic places where they just don't think about it, you know? And so how to make that happen is, you know, we've written some letters, which, you know, in individual situations sort of brings things to people's attention. But I think how to make that happen on a systematic basis is such an important question. Other comments from the audience? Or do you want to? So, you know, I think we've heard some wonderful success stories from people on the panel. We've also heard about barriers from both the speakers and the panelists. And I think our next session is about how to start to break down some of those barriers. So thank you. Thank you to Rachel and all the panelists and the audience participation. And we're going to take a break now. We will reconvene at 3.10 for the second half of the program. So we entitled the session two here, Working Towards Solutions. So I think you started hearing some of them in the beginning, but we are going to devote the second half of this program to that in depth. So our first speaker is a young woman So our first speaker is Tom Dearing, who's going to speak about ending gender inequality in cardiovascular clinical trials leadership. Tom is a past president of HRS. He's also at the Piedmont Heart Institute in Atlanta. So Tom, thank you for being here. And he's already warned us that he needs to go chair another session. So we're very grateful that he fit us into this afternoon. Thank you very much, Anne. It's an honor to be here and to be able to present at this particular meeting. And I do apologize for not being able to stay for the panel discussion. And in the app, as you will see, I am allocated 25 minutes. So I figured I would use 24 minutes and 52 seconds to do that. Just kidding, I kept it in the usual standard manner. There we go. So, again, it's an honor to be here and to be able to talk about this topic, and I want to move into the solution situation. And in doing this, I want to focus on five particular things that I think drive us to the solution. The first couple will be a little more theoretical, and the latter two, general and stakeholder solutions, will be very concrete. So some of this has been covered before, but I just want to address it. That is the rationale for coming to a particular solution on this. You know, Rachel mentioned before a quote, which I think one could contribute to Minow Walsh, which was, in business environment, diversity and inclusion are increasingly recognized as requirements for optimal organization performance. And Michelle Obama said the more diverse your team members are from one another, the better decisions they will make and be part of your company. Those are, you know, general terms. I brought it down specifically to the PIs, saying that having participating clinical trialists achieve more research opportunities, enhance their career development, obtain better faculty roles, and have an opportunity to influence regulatory and policy decisions is important. And that's important for career development and for excellence. Colin Powell said, excellence is not an exception, it is a prevailing attitude. So what we have to do to move forward with, you know, engendering and gender equality is actually look at this as exceptional, not excellence always. So the crux of the problem, and I know some of these things have probably been addressed, I wasn't at the whole session, because I had another session beforehand. And I wanted to look at a few things, and starting here. If you look at it, there are two specialties in cardiovascular medicine, electrophysiology and interventional cardiology, that have a smaller percentage of females. That's something we need to look at. If we can't get more females into the specialty, we're going to have a harder time having, you know, adequate representation as clinical trialists. And this is the pipeline, as you can see. It starts off with a little more than 50 percent of medical school students as females, but by the time you get to the fellowship level here, it's really become a trickle, as opposed to a, you know, robust flow. And then if you look also at career prospects, men tend to, compared to women, think that they can get better opportunities to effectively advance their career. So there's a situation here that we have to address on an attitudinal or a psychological level. And then if you look at the overall professional satisfaction, you can see men are, again, more satisfied with their career in cardiovascular medicine than women. So we have to address these underlying, you know, somewhat intangible situations so we won't get further. Now, if we look at program chairs, and there are several of them here in this room, you look at 69 percent will say that diversity drives excellence, but only 6 percent see it as a top priority. And I think during the last panel discussion, there was some topic or some conversation about, gee, people really just don't pay attention to it, as you mentioned, Dan. And that is something that needs to drive and needs to change. So let's look at the quality and the effectiveness. Now, many of you are familiar with Cochran Reviews. They're really well done, very detailed publications that look at the literature. And you can see almost 50 percent are led by women in cardiovascular medicine. However, when you get to the guideline documents, it falls by two-thirds to a half. And then when you get even further into editorial positions, and I know we have one of our editors or had one of our editors in this session earlier, you can see that it's slightly under 10 percent. So these change in career opportunities differ, not based on quality, not based on expertise, but probably based on other factors. If you look at this study that was published about four major journals for cardiovascular PI leadership, you can see that only about 41 percent had no female investigators, 9 percent had females as the first authors, 10 percent as the last authors. There were no female physicians on, you know, 55 percent of the leadership committees, and only 11 percent on the leadership committees in total. So again, those are changes that need to be overall looked at and overall addressed. How about other specialties? Are they doing better than us? Absolutely not. If you look at these things from orthopedics, critical care, and oncology, and I pulled a whole bunch of them. I just wanted to get them onto one slide. The difference is not an EP-specific situation. It's a general overall situation. Now one thing I thought was that, okay, well, OBGYN, maybe that would be something that would have a higher percentage because it is, you know, predominantly a female-led field in terms of clinical work, in terms of research, but again, it's only 50 percent. So again, there needs to be an intrinsic look into why those situations exist. Now my wife, as Andrea knows, is an academic, you know, clinical psychologist. And if you look at their annual meeting and you look at the changes over time in terms of the type of session or the type of role, they're running at about the 50-50 split. And they, like the medical school graduates, are about a 50-50 gender mix. They're doing something right about being able to do that. So maybe we can learn from colleagues in another specialty that is not ours. This American business executive, Mel Robbins, said, you have the power to change your life. Just start with changing your thoughts. So part of my initial thing is there are problems here, and we've got to get into our own individual mindsets and realize where we're making mistakes or we're not understanding the whole picture and change accordingly. So then I want to get into the two components of the solutions. The first is the general, and then I'll get into the specific solutions. A number of these things about, you know, what are some of the problems have been gone through before, and perception is reality. And these solutions are going to vary. They're going to vary across, you know, all of the different components. Why is it that women don't want to come into our field and then become clinical trialists within our field? So I list a couple of the ideas here, and I'm just going to run through them very quickly. First of all, there is interest in another specialty. Well, we've got to figure out why that is the case. We've got to engage people early on so they find this to be an exciting field, and then within that, there is the research opportunity that can manifest as their careers develop. There is a culture of an old boys club, and I am an old boy right now. I don't belong to any clubs in the world, country club or other club, but there is that culture there. We've got to really, you know, change that mindset into an all-person club. And there is sometimes discrimination or harassment, although I don't think that happens a lot. I may be missing it because I wouldn't be experiencing it directly, but we've got to make sure we minimize that completely. There is life-work imbalance and radiation concerns. The technology is addressing the latter effectively, and hopefully will continue to allow us to do that, not only for females, but for males as well. But life-work imbalance is a consideration. I have to say, in my career, my wife and I are both professionals, and she took much more time, you know, out of her career to help raise our single daughter. And I am immensely indebted to her for doing that. And what that did is it put her career a little on hold for a while, but she was able to get back on track. And I would like us not to put our career on hold, but to actually be able to continue to develop while that goes forward. And then there is also a lack of career advancement and a lack of female role models. Now, we need both of those, and that has been talked about previously. But I would also say we don't just need female role models. I wish I had female role models, and I did have many. I wish I had more female role models when I was in medical school and in training. And I also think we need to have gender, you know, distribution, so that we're all working together, and across not just gender, but across ethnicity and across other components. And then there are financial concerns, and it was brought up before about, you know, the payment needs to be equal for the type of work you're doing. And it also needs to be looked at in terms of what truly is value. That's not going to change today, tomorrow, or next week, but it is something we need to look at. Thomas Sowell, who is a professor at, you know, Stanford University, said, mistakes can be corrected by those who pay attention to facts. Dogmatism will not be corrected by those who are wedded to a vision. I hope that some of these errors, some of these problems are more a lack of vision than they are more like not paying attention to the facts than a fixed vision. I think that's the case, but I could be in error. So now I want to move on to the stakeholder solutions, getting very, very specific here. I had the great opportunity to be included on a paper which Fayez Zana, who is a clinical trialist in France, initiated this consideration, and it was titled Ending Gender Inequality in Cardiovascular Clinical Trial Leadership. So let's look at the subgroups that are within this. Now, many of us want to build a roadmap, and that's what we tried to do with this particular, you know, manuscript here. This is the Rand McNally, you know, roadmap. The first one was a railroad one, and then there were roadmaps. You probably can still buy them somewhere. I don't know that you can. Rand actually was born in the town where I was raised as a child for the first 18 years of my life, but now people tend to use web-based roadmaps. It doesn't matter whether it's paper-based or whether it's electronically derived. We need a roadmap to get to where we're going to be, and that's why in this section I'll discuss that. And these are the nine groups that I would like to look at, and I start early. I start with pre-graduate students, that is high school and college students. I mean, if you can get people at that age engaged in something that they think is helpful, and then you start getting them for part-time employment, doing clinical activities, and then some research activity, that will hopefully manifest in an arena. I have a niece who just finished her training as an ER physician. She has a father who's a cardiologist and an uncle. That's probably why she didn't go in that arena, but she got exposed to research early on, and she's doing great emergency room research. She started as a high school student doing that. So I think we need to start early. It needs to be broad-based, and we need to continue those connections that we start in high school through college, through graduate school, medical school, et cetera. The second group is the trainees and the early career investigators. Now we all know when we were starting early our careers, and some people knew exactly what they wanted to do and where they wanted to be, and some were stupid like me and were unsure, and that's changed over time. And if we can provide effective leadership, we will be able to hopefully open the doors for more participation. So I break it into two groups. There are the expertise competencies. We need to take these people who are interested at the female level and at the male level and train them on clinical trial design, on how to write a grant, how to operate clinical studies, how to look at what regulatory considerations you must take into account when you're evaluating and assessing a study, and how you manage data and analytics. Also on the personal side, we need to have involvement in networking. We need to expose them to that early on. The women seek mentorship, and we need to offer mentorship, and then there can be certification programs for training, et cetera, and there can be and should be leadership development programs and communication with skills and communication things. If you're going to be a leader and you're going to be driving a trial, you need to have all of those personal and those expertise levels. The second or the third group is the clinical trialists and scientists, most of which are at academic centers, but they're also at other institutions, and they're in industry. They're broad based. And what they need to do here, I put the three R's. They need to recruit, they need to reward, and they need to work to retain, and it needs to be broad based in both genders serving as mentors. The leadership training is a thing I mentioned earlier. Career development flexibility as one goes through one's career based on family issues that may manifest is important, and I think we need fair competency-driven opportunities for participation in clinical trials. That is key if we're going to do that, and leaders as clinical trialists need to be forward thinking and be putting this on the plate, not just giving it lip service. What about academic institutions? I think academic institutions, those same things that applied for the clinical trialists obviously apply. However, as strategic planning is put together for clinical trials, it needs to be considered how do we bring in more minorities and how do we bring in more females. It needs to be proactive for recruitment, retention, and for promotion. If you can't move up in the ladder of academics, you're going to get frustrated and want to move in a different direction. We need to develop diverse leadership teams, which will be better for the organization, and bias training is important. Now, is it explicit? In some cases, there is. Sometimes it's much more likely implicit and hides under the rug a little bit, which becomes more of a problem. Again, there needs to be fair distribution of research funding opportunities, and when there isn't equal numerical distribution, meet with the people who are in the minority group, the females, other minorities, and say, hey, do you want to go here? This is what we need to do to get you to get a funding the next time. The third group are catalyzer organizations. Now, those are a little bit different. Those are organizations or entities that are designed to facilitate and support persons and organizations without direct implementation for solutions. So they don't solve things, but they help to bring together and coordinate and collaborate, et cetera, so that goals overall can be reached. And here's a number of them as examples. The ACC has considerations. In addition to that, Fayez Zanad with CVCT has them as well. The European Society of Cardiology has these. We have, oh, there's women as one, and then we have our GLOW class at HRS. So there are a number of these catalyst organizations that we should be reaching out to and asking to join, participate, and help drive these initiatives. There are also professional societies, and this was talked about during the panel discussion recently. These are the four major arrhythmia societies, but there are smaller ones as well. The societies need to create awareness that there is a problem and then encourage solutions that try to address this issue. General education to increase research knowledge among trainees, whether you're female or male is important, and then we need to provide a resource of database to potential child leaders for underrepresented groups, to industry and to government funders and to other funders. And we need to assure diversity in societal leadership. So it's not always an all-boys club, but it's based on distribution across the board. Industry is also another consideration. That's my seventh one. Seventy-five percent of industry payments are made to male physicians from this particular study that was done looking at it. And if you look at what does industry need to do, we talked about it a little bit in the panel beforehand. I think industry should establish internship and sponsorship programs for women and for other underrepresented groups who express an interest in that arena. Get them involved early on. Encourage women in protocol development, in leadership trial committees, in DSMBs. Get them involved in all those activities. That will lead to the potential for future opportunities. And develop gender-agnostic networking programs, in my opinion. Collaborate with those catalyst organizations, I think is really key, because they can help facilitate some of those components, and close that gap on industry boards and leadership teams. So again, it's not all, you know, Y-chromosome sitting at the table. In terms of the funding agencies, whether they be governmental or whether they be industry or whether they be, you know, startup companies, I think it's important that they be broad-based. You know, the U.S. National Institutes of Health does recognize as part of its mission that it depends on scientists from a variety of diverse backgrounds. The same thing is true in Germany and the United Kingdom and in a variety of other geographies and institutions. So that's, I think, an important thing. I mentioned earlier a slide that editorial board members, 10 percent, less than 10 percent, you know, were women in nature. I think we need to have appropriate competency-based selection processes. It shouldn't be just all old boys network. For all of the editorial positions, from editor-in-chief down to the editorial board members. And I would argue for manuscript review, it's not done in many societies, but it should be blinded. So you're not worried about, oh, I know this guy, I know that guy. I'll vote for them. This is a great manuscript. I personally think they should be blinded. They're not always. Again, Bren Brown said, Breen Brown said, who is an American consultant said, there is no innovation and creativity without failure. We are not going to go forward and solve all this problem without having two steps forward and one step back. I hope it's always more steps forward than steps back, but we've got to make sure that we move in the right direction. And when we have failures, we've got to address why did we fail, how can we make it better, and how can we move forward in a better way? I'm going to finish up with my final thoughts. This is the summary diagram that we put together for that manuscript in which I was privileged and proud to be included as a member. And what I say is we need to, one, acknowledge that there is a problem. Number two, we need to commit to optimizing policies that will result in better outcomes. Three, we need to evaluate the progress over time. Are we getting where we need to be? Are we falling short? Are we doing better than we thought? We need to define the metrics and assess the progress, and we need to have the discussion about roadblocks. When we run into a roadblock, why did we hit a problem here, and how can we address it? If we don't do that, we won't be able to go forward, and we need to engage multiple stakeholders. This is not just a single gender issue. This is not just a single country issue. This involves multiple stakeholders in multiple arenas. And there has to be a willingness to speak up when you hear something or see something that is inappropriate, or you just have a suggestion about something that would work. Shyness does not work here. Ask questions. That's my last point. I think it's very important to ask questions. Albert Einstein, who I hear was a pretty reasonably intelligent guy, said, strive not to be a success but rather to be a value. Now, don't misinterpret me. I'm not saying that we don't want success. We do. But what we've got to really do is work together to create value. And my opinion is if you create value, you, by definition, are creating success. So I will stop there with this picture of our 40th Heart Rhythm Scientific Sessions. I see many close friends, colleagues, and people who I enjoy working with and have had the opportunity to be blessed to do that over the course of my career. I also see in the center there one of our former presidents who succeeded me immediately with her husband and with her son. This is not a gender issue in a sense. It is. But it's a human issue. We need to do better so that we can all achieve that which we need to do. Because not only will people have better career satisfaction, society will be better off. I thank you very much for your attention. And Anne and Andrea, thank you for allowing me to participate. So thank you so much, Tom. That was great. I don't know if there's anyone from the audience. or anyone from the panel would like to ask him. Well, it was very good. It was a great. No, it was a great next steps in what we need to do. Thank you so much. Let me go ahead and introduce our next speaker is Janice Chu from Mount Sinai and she is going to talk about ACC Clinical Trials Research Program. We'll hear more about maybe some next steps. Thank you. Thank you so much, Andrea, and thanks so much to both Anne and Andrea for this invitation to be part of this very important symposium. Let me go ahead and just pull up the slides here. This has been a fantastic afternoon. I feel that I learned so much from everyone, from the speaker and the panelists, hearing about people's different journey. Also earlier in the afternoon, we saw that very few people actually were aware of the ACC Clinical Trials Research Program. I'm delighted to say that I'm here joined by two additional alum, Valentina Kutifa and Pam Mason, who were both with me as part of the inaugural class and tribute to Dr. Curtis's leadership in this program over the different years. So today I'll spend a few minutes talking about both my thoughts and reflection on a robust and evolving ACC CTR program, as well as some of the details and programmatic information shared with me by the ACC team. I hope these will be helpful to the group here. I will finish with highlighting a few questions for us to further ponder during the upcoming panel discussions. So first, as we saw, the ACC has a clinical trials program that when it first inaugurated was really named Upping Your Game. This is really aimed to amplify the know-hows and the know-who for people interested in clinical trials. In the very beginning, this was marked and directed at all the ACC members as part of ACC's commitment to diversity in clinical trials leadership. For the ACC, this is part of the culture of inclusion. And I think this actually resonates with a lot of the talks and slides that we've seen this afternoon. Specifically, I want to point out a lot of the considerations really in thinking about the entire pipeline. As Tom has just suggested to us earlier, he's thinking very, very far upstream, including high school students, the pre-graduate students, going to the graduate student, going through all the different career stages, and into the different stages of clinical trials leadership, then backing out big picture-wise to the societies and to the entire organizational level that influence the entire picture. From the ACC side, part of the recognition is thinking about leveraging and engaging the talent to develop a deep pipeline. And this includes recruiting the talented individual, retaining the individuals, and bringing them to leadership. And guess what? The recruitment and retention are also words that we use in clinical trials. So we do see, as Uma suggested earlier, a lot of the way that we're thinking about clinical trials leadership also apply to clinical trials participation, and the two really go hand in hand. Similar to what Tom has shown us from a broader societal level, there are also data benchmarking, thinking about accountable execution, and eventually realizing the value of diversity, which in our mind is also maximizing generalizability. The goal of the ACC Clinical Trial Research Program was to stress the problems and to implement solutions in clinical trials research, very much resonating with this afternoon's symposium. The problem that was identified was that too few women and underrepresented cardiologists were present in clinical trial research leadership. This had implication in terms of lack of diversity of thought, lack of diversity in participation, and lack of diversity in leadership. This further limited the access to a talent for research enterprise. From the ACC standpoint, this was looking at the entire cardiovascular landscape. This also had implication that it lacked opportunity for women and underrepresented cardiologists to be part of the investigator pipeline. I think furthermore, we will also argue that these have implication on the perspective in study design, study outreach, recruitment, execution, and generalizability. An article I think that would be of great interest to this group that we didn't include today actually came from one of my heart failure collaborators, Carol Lum, who did a beautiful job in capitalizing why it's important to incorporate women in clinical trial and clinical trial leadership, whereby, for example, in the study design, you would think about some of the dose-finding issue, the PKPD, when it comes to pharmacology. In terms of outreach and recruitment, you would think about recruiting women in places where women tend to spend their time. You will also think about recruitment and enrollment in a more flexible schedule to help balance childcare responsibility. There are also additional thoughts in terms of the study execution, generalizability that I think would be quite applicable to many of our arrhythmia trials. Therefore, from the ACC standpoint, the solution proposed include, increase the diversity of clinical trials researcher to improve science and enhance innovation. To add underrepresented women and racial ethnic scientists to increase a talent pool. And with the attention to diversity across clinical research leadership, design and execution, and empowering women underrepresented clinical trialists to improve the evidence base and enhance patient outcomes. From this, this is a version that I've adopted from the ACC. And when I saw it, instead of three different discrete item, I really actually saw it more as a cohort and a curriculum merging together as a beautiful marriage of two sides that very much resonate what Tom had alluded to in terms of different kinds of expertise and personal competency. What the ACC did was the ACC realized that on one side, you need to identify a cohort. On the other, you need to deliver a curriculum that enhance the cohort. And altogether, this develops a network. So by this for the cohort, they wanted to identify through the clinical trials program, a highly competitive applicant pool seeking to advance clinical research training supported by their institution. This had twofold, they're actually quite important. One, it's a personal motivation that's in there. It has to be someone who is actually generally interested in pursuing this path. And the institutional support, at least demonstrated to the program, was a starting ground that's quite important as well. Then for the cohort, there was also the careful consideration in terms of thinking about the diverse group of learners, including those many of whom may lack local access to specialized research training and mentorship. From the career clearance standpoint, that the ACC wanted to be sure to deliver a curriculum aligned with prospectively determined clinical trials competency. So this highlights a lot of what Tom alluded to in terms of the expertise, the competencies related to expertise needed for clinical trials. This includes professional development topics and exercises tailored to career advancement and clinical trial leadership, interactive and instructional design, optimized adult learner, and an altogether nurture a network of program alum. I'm excited to report that this is the breakdown of the CTR cohort over the years that it started. In 2019, when it was first inaugurated, this was actually focused on women. The entire first class was to promote women in clinical trials and women to advance in clinical trials leadership. The organization recruited 45 women that they had selected for an applicant pool. And this had a diverse racial breakdown as well. Pivoting onward to the subsequent years, the organization decided to be more gender neutral and focus more of the effort on really bringing it up some of the other racial diversity that were not as represented in the first cohort. So you see over the subsequent years, the gender balance became more 50-50, and also that there were additional racial minorities that were further enhanced. In the most recent cohort, there was an interesting exercise that the organization took on, which is specifically including a subspecialty cohort. This was the structural heart disease cohort at that because of funding and a partnership with industry was able to take off and to specifically enroll fellows and early career investigators who are in the structural heart disease hemisphere to train them to become clinical trial investigator. A major focus of that was to heavily involve members who are from underrepresented minority groups, whereby the thought process and validated thought process is to have a pipeline of people who are in these communities who really further consider the needs and the intricacy of the community and develop them as leaders and clinical trial leaders so to better engage those participants and retain those participants as well. Here's a quick summary of how the program has also evolved. In addition to the evolution of the cohort, the program itself has evolved. The initial cohort in 2019 had an excellent two-day program at the ACC Hearthouse, which I think most of us felt were quite impactful, being their in-person networking, speaking with the ACC leaders. This subsequently became even further enriched to include virtual component. I will point out that, of course, here we know was the hit of the pandemic. With the pandemic for the subsequent years, immediately after that, the entire program were completely virtual. Subsequent to that, a couple years later, both the in-person and the virtual components are now in place. So the most recent class actually had the in-person meeting in addition to a series of virtual webinars that will continue throughout the year, and now with an addition of a capstone project and subsequently also the development of a research award pipeline to help with pilot awards. So there are a lot of different evolution that we can start seeing bits and pieces of this, it really adding to this very rich repertoire. Alongside these, from the networking standpoint, there's been a listserv that's been kept for the alumni, and there's an annual alumni network reception at the ACC scientific session to allow for in-person meeting and more networking opportunities. The curriculum was developed based on the learner's need and the consensus competency. Some of these include the scientific concept and research design, ethics of human subject research, investigational drug and drug regulation, clinical research operations, good clinical practices, studying and site management, data management and informatics, clinical research leadership and professionalism, communication and teamwork, and I hope that you will see many of these do touch on the competency that Tom highlighted earlier. Some of the specific sample session I want to give you a taste of include anatomy and organizing a clinical trials research, FDA drug, drug device development, a regulatory competency consideration pertinent to many of our discussions today about industry collaborations and then disclosure, in fact, delivered by Dr. Curtis when I look back at the agenda back in 2019. How to excel in clinical trial roles, being a site PI, this was Emily's question from earlier, being a national PI, part of the steering executive committee and best practices, and again, you would imagine that even for the learners, for all of us going through this, their career evolutions that those who learn about becoming a site PI would later still want to take a course about becoming a national PI, as Patty was saying earlier, so I think there are many ways that we can continue to build on this. Lessons on trial design, data sources, data analysis, finding funding to match your proposed research, components of a fundable grant or industry research proposal, how to access clinical trial leadership roles, I think this is still of interest and can probably be further developed, and creating a personal action plan for a clinical trials career. What I think the ACC clinical trial has done very well is thinking about developing a curriculum which I will encapsulate as the know-how. What you know, what you know matters. You do need to have the competency of the knowledge, but also who you know, the network, the know-who. I think both of these were taught as part of the ACC TTR program, have been continued to be nurtured through the alumni network, and probably could also have more advanced version of these that can either be supported by HRS or additional programs going forward. I will also offer, similar to, I think it was Uma who did a beautiful C, she had six Cs which I thought were perfect and I took a picture of that, so I'll have to give her my appreciation subsequently. These were my five S that I came up with after being part of the program. And I think that hopefully you will find that these resonate with you and these resonate with why we are all sitting in this room today. The five S for me coming up the Clinical Trial Research Program were, the first S is for a sense of purpose. And this was actually hit home in the workshop for us. I'm thinking about the mission, our own mission and vision as a clinical trial investigator. But I think part of it is also the motivation for why you want to do it. The second S is sweat. I think one thing that we heard from many of our successful mentors over the years was that there's a certain element of grit and persistence. And I think Kamala said it very well earlier, I think maybe if you ask the first time you didn't get hurt, you still have to keep asking that persistence actually does matter. The third S is for support. And this is also highlighted very well today thinking about mentorship, resources, sponsorship, they're all part of support. The fourth S is synergy. It has to make sense, it has to match in some way with the rest of your existence. Be it your clinical practice, the rest of your work-life balance or anything else that you need synergy with in your life. And the last part, the fifth S is serendipity. I do think that a lot of the opportunities that come about rather opportunistically. Serendipity, you may get to know someone, an opportunity may open up and it may not always be what you initially thought of or asked for, but can become learning opportunities that can take you to the next step. In my concluding slide, I want to sum these up together for us. I think the ACC Clinical Trial Research Program has been a very robust program in terms of the different elements that are partly important with the know-how, the know-who and the five S's. For us to further consider, I want to leave you with these questions that we may want to further discuss during our panel discussion. What components are still missing after we thought through the Clinical Trial Research Program? What components need to be further emphasized? What new and evolving issues in clinical trials and the overall research landscape must the solution also address? What lessons can we collectively learn from other solutions or other pathway in clinical trials leadership? I will end here and I look forward to hearing from the others during the discussion. Thank you. Thank you, Janice. That was excellent. And as you said, since I've been involved in that program from the beginning, we can discuss that more during the discussion. Our next speaker is Taya Glotzer from Hackensack Meridian School of Medicine in New Jersey. And we've asked her to talk about development of a research network or database of women electrophysiologists. Taya. Thank you very much to Anne and Andrea for inviting me. And I just want to say that, while my slides are coming up, that mentorship is so, so, so important. And even if it's a mentor that you never even met, and I actually had to look it up, but I remember when I was a medicine resident looking at Cindy Grimes' name on papers. And I was like, wow, there's a woman doing cardiac cath, and she is in it, and she is successful. And that meant a lot to me. And then Anne was the next person who I saw. I remember she showed a picture of herself and her children, and she was the head of HRS. And I was like, I can do this. I can definitely do this. So I didn't even know Anne, and I certainly have never even met Cindy Grimes, but they were huge mentors for me, just because they were present in the distance. So I was asked to talk about development of a research network or database. And I will start here by saying women represent 20% of cardiologists globally, 5% to 15% of electrophysiologists, and they hold less than 10% of leaderships in the field. So our mission is urgent. And despite their vital role, women in cardiology face systemic challenges, salary gaps, limited mentorship, workplace discrimination, leading to high rates of attrition, and decreased leadership positions. And increasing the representation of women in cardiology has demonstrated the potential to enhance outcome in cardiovascular disease. So women cardiologists are critical to serving diverse communities, yet they face an uphill battle. There's a burnout crisis. 57% of female cardiologists report burnout. There's a pay gap. They earn $2 million less than men over a 40-year career. There's sexual discrimination. 75% of female doctors face sexual discrimination in their first year. And there are higher rates of attrition. So a dedicated database could tackle these issues by tracking career progression to identify systemic bottlenecks. It could highlight salary disparities through anonymized compensation data. And it could do mentorship matching, connecting early career women with senior electrophysiologists for guidance on navigating training, work-life balance, and leadership opportunities. So supporting research and advocacy, we can do sex-specific data aggregation, centralizing studies on gender disparities in arrhythmias, device therapies, and response to different drugs to inform guidelines. We could do clinical tracking to monitor the enrollment of women in trials and promote gender-balanced research designs. And a research database could be a resource hub for radiation safety, flexible scheduling models, and strategies to combat workplace discrimination. So this is a site that already exists, Women as One. I took some of these slides from them. And their mission is to promote talent in women. And it was started by Roxana Mehran, who is an interventional cardiologist in New York. It was founded in 2019 by Roxana and this Marie-Claude Maurice, two internationally recognized leaders in cardiovascular care. And their goal was to create an organization focused exclusively on improving working environment for women in medicine. And their mission is to promote talent in medicine by offering women cardiologists unique professional opportunities. And by doing this, they aim to build a more inclusive, diverse workforce in medicine. And Women as One, which I'm going to give you the QR code, so get your phones out, offers five key solutions to empower and support women in cardiology, funding, training, professional advancement opportunities, a global support network, and mentorship and sponsorship. And they have a database already, which we can join. This is their talent breakdown. And you can see that they really only have 7% electrophysiologists. But you can also see that they are all over the world. And in terms of the women that are registered who do research, 793 conduct clinical research at their site. 542 are interested in clinical trial leadership. And some almost 300 have clinical trial leadership experience. And these are the types of research they do, the types of academic research. And then this is the type of clinical research they do. And this is what they say. We must invest in women. We can't afford not to. So if anybody wants to join, I actually signed up after I was told I was giving this talk. I was like, oh my god, what am I going to do? So I contacted Roxanna, who I know. And she shared these slides with me. And this is their women as one talent directory. So this is one women database. But we have a women in EP database, which can do dynamic networking beyond traditional models, career stage specific support, shadowing opportunities for early career members, and senior electrophysiologists can share strategies for success in research. And the database can match research opportunities with others who have similar interest. And it can also use it to find expertise on speaking topics. And this is the database. And we have to thank Chris Patton, who really should be giving this talk. I have no idea why I'm giving it, who started this. And I highlighted my own name there. And I'm going to show you the fields. And I'm going to give you a QR code. So for those of you who are not on it that want to join, this is a fantastic resource. And these are the fields in our database. The ones on the left are just your contact information, basically. But the ones on the right, you put in your research collaboration areas of interest in areas you're interested in speaking about. Are you interested in any opportunity? Are you interested in peer review statements or guidelines? Are you interested in guideline or consensus document writing groups? And do you have relationships with industry? And I think we have used this. Leaders in the room have used this database to look when you need a speaker to talk about cardiac sarcoid, you can quickly go to this thing and find a woman speaker to speak. And this is the QR code. If anybody is not part of it, if you take this picture, you can get to the data sheet and enter your own information. And then Chris not only created this sheet, but she has an email listserv that she sends every time they need somebody to write a guideline document or something. And so if you want to get on this email list, you have to email her because she won't know that you entered your information on the Google sheet. So that's her email address. And then when they need somebody on a guideline document about sudden cardiac death, she will send out an email to all the women on this thing and say, is anyone interested? Forward your name. Forward your colleague's name. Suggest people. And I think it's been an amazing database that we have all used to promote each other as women electrophysiologists. So the future of this kind of database, we can increase female-led studies in electrophysiology and publications by female authors. We can retain women in electrophysiology because we become friends and we love to meet with each other. We can increase leadership roles, conference speaking, and committee positions. And the data will provide actionable insights for recruitment and retention. And then the final slides I have are just, this is another WhatsApp group that those of you who are not in it can join to work together, collaborate, and promote each other. And finally, Twitter. Hashtag Women in EP, which is, I think, what our buttons say. Hashtag Women in EP is the Twitter handle. And then two meetings I just share with you, last two slides. This is RISE. This is a meeting that's going to be held during ESC in August about, you know, it's held by Roxanna and Leal Zucchi, and the theme of this year's event is Leadership on the Global Stage, featuring attendees from 40 countries. And the agenda will be roundtable, discussions, executive coaching, speed mentoring, and morale. And then this was already mentioned, but these are the details of the HRS Research Network Initiative that's going to happen on Saturday morning at this meeting. So these are the details. And the room location. And I thank you for your attention. Thank you. Okay, great. That was wonderful. So now we have our discussion time, and this is going to be led by our moderator, Dr. Ricky Green. The whole topic that we're going to talk about is changing the current paradigm. What do we need to do next? What do we take home from this meeting? So please come on up. And then we have panelists, Sana Al-Khatib, who is one of the incoming soon-to-be, in the leadership track, soon-to-be president of HRS, and Dr. Sabine Ernst, who will also be a panel member. I think everyone could fit, so, yeah, I don't think anyone has to move. All right. Well, I'm happy to take this away a little bit here, and, I mean, these have been fantastic discussions, and I've enjoyed listening to everyone's excellent thoughts on how we can do better. I'm just going to—we have a lot of people up here on the panel. I feel like I would like to go start from one and then work our way to the other, and I want to hear one thing from each of you that you would like to see happen in the next five years, the most important thing, starting all the way down there with Sana. And you can expand a little bit more, because you and I are on the kind of last panel here. You get more than two minutes. Thank you so much. So you mean in terms of the, in relation to leadership of clinical trials and women. I would love to, this is pretty simple and straightforward. I would love to see more women leading clinical trials. I mean, so this has been an interesting discussion. I'm sorry, I had to miss a lot of it because I was busy with other aspects of the meeting as program chair. But it's wonderful that we're having this conversation at this meeting. And I just see this as the beginning of hopefully a long journey for us to work on this because I think it's gonna take a lot of work. I know we have an intention to put like a white paper together to kind of summarize all of these great points that have been made during this session. But you know, our work extends beyond that. I think we really have to leverage some experiences. As Janice said, she shared her experience with ACC. But I really truly feel that we should do a great job looking at all the existing platforms that we can leverage to enable us to be successful. Because ultimately that's the vision is to have more women leading clinical trials, leading research. And it's really, it makes me very sad to see like this landscape is very much dominated by our male colleagues who are doing a great job. I'm not taking anything away from them. But I think there's so much value in also women leading or co-leading because there are so many aspects of research that we can really do a good job at, especially enriching enrollment of women in clinical trials. Things that we can think about, that we can relate to and identify with that perhaps some of our male colleagues may not. So that's the vision for the future. I know there are so many steps to take, but I'm very encouraged by this first step. Thank you. Tanya? I'm so glad I had a minute or two to think before I had to talk. I mean, I think the main thing is that number. You know, 10% of electrophysiologists are women. So I would say in the next five to 10 years, I'd like to see that number double or triple. And then I think if there are more women around, they'll be more likely to be part of, it'll just balloon. And I think I said to someone, I don't know who I was sitting next to, you know, I mean, women do a really good job. They work hard. And I think if we're here in bigger numbers, we'll be recognized and noticed and we'll become the leaders naturally. Sabine, you say something a little bit more from the non-US perspective. I would love to hear that, being that you are from Germany and work in England. Yeah, so, well, that puts me off a track that I had in my head. So which is fine, which is fine, it's fine, it's fine. No worries. So I have a number of kind of comments that can kind of popped up into my head. What is the key is, I think, and that what we have seen over the last, again, 15 plus, 18 years probably, since we all met once at EPIC. I think it's a long time ago, but I think we have managed to move up and the fact that we are now at 15, 20% is already testament to that, that we actually, funny enough, all of these women who were in those initial group tended to kind of grow up together. And in a way, I've tried very much, and I think you've all emphasized that, is to continue to do this for the next generation. I feel now I'm in the kind of more senior role now. I was very junior when I joined that group. So I thought, okay, how can I continue on this? And part of that is being in the program committees, putting the work in, and it's hard. And if you have a young family, I don't know where you take the time from to do all of these things. And so I think you need to adjust to the situation of colleagues who are having kind of a double commitment of not only trying to do research on a high level, but also trying to run their family and to do their clinical work. So we need to balance that in a way. But on the other hand, and I think the databases that you have shown, all of that works together. And the last thought that I had actually was, that was the main point that I tried to do, is this visibility. Now, I don't know what you see on your LinkedIn feed. I'm not on Twitter, but on my LinkedIn feed, I see all of these fantastic women who are showing up and say, I did this lecture, or they complain about, in the WhatsApp group, all male panel, again, from company X, Y, Z. And we are kind of supporting each other and we're demanding now. And I think this is the real, what I think we need to do in the next five years to not only wait until serendipity kind of helps us along the way, but we need to go forward and actually demand and lean in far more than we have done so far. So we talk about lean in when we met first, but I think we need to lean much further forward. So we need to be a bit more courageous, I think that's the bottom line. And not be embarrassed that maybe our colleagues might be embarrassed or whatever. So just go. And Janice, I loved your points about the ACC. Is there something there that you, you raised a number of questions, which one would you like to kind of take forward? Thank you, Ricky, always great questions for you. I think for the current discussion, actually, I think bringing in some of the ACC thought, but also actually heavily reflecting on comments made by my CTR alumni earlier, Valentina and Pam made two excellent comments that actually really made me think. I think I would love to see our group more mainstream, more mainstream, more main stage. I think that the discussion that, in this morning's opening session, when Pam brought out that, I think was one of the earlier ACC clinical trial late breaker presentation that the only ones that had women PI up there presenting the main data as a lead PI were the ones that were female centric. And I think that women investigator can be mainstream. We don't necessarily need to just be female centric. I think we can lead and lead in ways that encompass the entire society. So I think that's a direction that we'll really love to help nurture all of the clinical trial direction into it and very much hope that our group will be able to help accomplish that. I think the other aspect of ACC that was interesting was that it really emphasized the thought in terms of vision and mission. And I think related to that, what Sabine said actually really resonated. I think for lack of better way of categorizing things in my head, I once heard of the three Vs. I guess many of you are probably quite familiar with this, which are vision, voice and visibility. So I think that perhaps that applies very much here in terms of clinical trial training and clinical trial leadership for women in EP that I think it would be important to have the vision, which is why we're all here, to give ourselves the voice to be able to lead together. But I think also a main challenge here is indeed the visibility. And that includes being able to rally the support of the entire society, both women and men. Sabine. Yeah, just because you raised the topic, and again, it triggered some of my thoughts. This research network initiatives, no matter in which kind of area it is, I would love to have this, not only like a US kind of focused one, but we need to do something like this in Europe as well. And Europe is so diverse. If you apply for a German fund, national funding, it's completely different from the UK one or the French one or the EU funding that is available to various countries. Sometimes you have exceptions where people can't join. But that is such an open thing. And I love all these initiatives. But in a way, it should not only be for the participants who are selected few, I don't know, 40, 50, 60 people who are getting a fellowship or kind of a specific grant for a time even set aside for that. But the information of that should be open access. And I think that's what we really need to do so that people who don't have the time to attend these classes, at least can in their own time, watch the online YouTube, whatever resource to it, or download the slides or so, so that they can work through it when they have the time to do so. So I think that kind of open access is very important for women who are not necessarily have the time to do it in a specific timing. Selma. So I wanted to actually highlight a couple of points in relation to the times that we're living in now, especially for those of us who are in the US. We are very worried about the future of research here. And so many of us have put together so many grants that were targeting the NIH and PCORI and all these government funded agencies. And we used to think that it was near impossible to get funding. Try again now in this type of situation that we're finding ourselves in. So I think it's incredibly important for us to intensify our efforts if we want to make a progress in terms of becoming leaders of clinical trials, because what's gonna happen is that a lot of our colleagues are going to be targeting industry for research funding more so than ever before, which means that I think it is important for us as women to support each other, to think of each other. If you know of someone who has a certain area of expertise and the company is looking for that area of expertise, I think we really need to be supporting each other more than ever before. I also feel that you need to prove to these industry partners the value added from having women in leadership of clinical trials. And I think the angle of increasing enrollment of women as well as underrepresented minorities in clinical trials is I think an important one. And we know of many examples where when women actually let clinical trials, enrollment of women improved and increased. So I think, and we have to all put our heads together to think of other ways through which we can prove to those companies that when women lead clinical trials, there is added value. And this is one example. I'm sure if we all think about it together, we can think of other examples. Andrea or Ann, I was actually gonna ask both of you exactly what you were thinking, talking about here, that we live in difficult times. This is very, it's a research climate like we have not really had before. And here we are talking about the diversity and we shouldn't even say the word. Do you two feel that there are things we need to do differently now? How are you looking at the future under the current circumstances? Yeah, that's a great question. So I think one of the things that struck me before Sana spoke is exactly is to, I'd like to see these numbers change, right? I'd like to see in five years to have a certain increase in percentage of women who are PIs on different studies. I think that we as a group might have more influence or ability to put together some, whether it's a research network through HRS, I don't know much about that particular specific plan. There's been discussions over several years on how that would be, whether it's the collaboratory, the EP collaboratory, whatever it is, is that whatever we look at as leaders of these studies and maybe have other women, first something like Valentina did, right? You have PIs, local PIs, you put a leadership group together sponsored by, obviously that was a device company, and then have a lot of the local PIs be women and then have more women lead these trials. But I think it's unfortunate, well, fortunate or unfortunate, I don't know, but is going to industry for more grant funding as opposed to right now in the US and the NIH. Maybe we could do some of these things, collaboration internationally. I mean, some things we might be able to, some might be a little harder, combining data depending on what the regulatory agencies show but I'd like to see those numbers change and set realistic goals. Clearly we'll have challenges, but a realistic goal of an increase in 20% in five years or something like that in authors and then other authors on papers too, if you're a part of the executive committee or the steering committee or whatever it might be called, those authors will have, and then you have more presence and then people get to know you when you're leading trials and publishing on topics. Well, I think this is gonna be a challenging four years, period. And one of the things I worry about is losing a generation of researchers, right? Because if you get too far away from it, it's hard to ever come back. So, I mean, even right now, I think for anybody to get very enthusiastic about writing and submitting an NIH grant, it's tough because you don't even know if anybody's gonna look at it, much less get to a study section or get funded. So I think that is a challenging situation. We do have industry funding that is possible. We know that, I mean, let's face it, industry is much more likely to fund studies that will improve or increase the use of their products. I mean, that's what they do. And that's okay because, I mean, that's how we got things like cardiac resynchronization therapy and ICDs and the drugs that we use. So there's nothing wrong with that. We just have to realize that if we go to them for funding, that that is a driver of what it is they decide that they want to fund. So I think that's okay. What would I like to see going forward? I would love to see somehow with an HRS research network that we fit women in there somehow, whether it is a subset of it, but I just think it would be a blast, really, to have a research question. And I don't, you know, for the reasons we said before, I don't want it to be specifically about a problem that's unique to women. Forget it. I mean, we take care of patients that are men, women, all different shape, sizes, all the rest of that. A research question that is important and prioritize having the site investigators be women. Doesn't have to be 100%, but what if it was 50%? Would it be a hell of a lot bigger than we have right now? And prioritizing at different institutions those opportunities for women. And getting more of them involved. The ACC Clinical Trials Research Program that I have been involved in, it evolves all the time. Pam Douglas has been phenomenal. The Minna Walsh, Tracy Walsh, they're great people in there. And I've been very fortunate to be part of it. And we do evolve that program based on feedback and what everybody needs. So it is a good tool, but it is just a tool. And it really is meant for launching people to get into research. But the next step is missing. And that's what I think I want to see us get to. So how do we put that together so that we can have some studies that answer real questions, that address things that we need to, but make sure that in the design and implementation of the studies that there are many more women that are on the executive committees and site PIs than we see in any other clinical trial right now. Yeah. And sometimes it can be even easier than that. I'm thinking about doing clinical research here. And it's wonderful to get NIH grants. It's wonderful to be PIs on multi-center studies. But sometimes what you want to do is write up your own experience. And I'm gonna use our own lead extraction database at UCC as an example of something that has been very valuable. And then when we need more patients, then I think, oh, I need a couple of other sites. Who should I go to? Well, I go to sites who do lead extractions where there are women, and we write it up. So I feel like we should all kind of think along those lines. It doesn't all need to be NIH. You know, it will never be NIH, for all we know. So maybe the time is just kind of go back to our own institutions, look to see what can you do? This is truly kind of like bringing back to the grassroots level, right? What am I doing? What could we do here? How can I get more of the people I know, my women colleagues, enrolled in studies that I would be interested in doing? So that's what we have been doing. Young Mae Cha in the Mayo Clinic and I, we've written many papers together because she does lead extractors, and I know her. And it's a great way to get stuff done. I wanted to ask something about the database that, Taya, that you talked about that Chris Patton has been the leader on. We know about it, and we know we can access it. How well do, I'm sorry? Yeah, okay. How well are we publicizing this to companies? To industry, yeah. Yeah, industry. How much are we pushing at them? AHA and ACC, I don't know the answer to that. But we should do a better job. It's not necessarily a database, as it is a list server of interested women EPs where you can put your, you know, like Tata was at the time. It's an Excel file, right? There's nothing more than an Excel file. But there's no, no, industry can't go look at it. It's not like the talent registry for women is one. And that, of course, would be spectacular if you could use it that way, yeah. Yeah, so that's what we have to think about is whether or not, I mean, they do, I learned about women as one by trying to put this program together. And so, you know, do we, we've talked about using what they've put together and then adapting it to our needs, and so expanding what Chris did. But also, is that, you're right, it's more of a list server than anything. Is that database something that, as it is, is it useful to industry? So, for example, one of the common things they love to say is, well, there aren't any qualified women doing PFA, right? Or nobody's done any of it. Well, what if you put down that you've done 150 of them? All right? You know, if you actually could give some numbers and expertise and get, so really to point out so that they can't hide behind that one, that there aren't. So, you know, are we providing the data that is helpful enough to move the needle on this? I think actually the updating, I think part of it is there's Chris and she's doing, so it's not necessarily updated and it's not that granular, you know, so not that it can't be done or expanded, it would just kind of probably need more than Chris. Right, oh yeah, yeah, yeah. So it would need formal support by, say, HRS, yeah. I think that's maybe one of the aspects of having it on a society platform. There are several kind of collections. There's Wavy that's sponsored by Biosense now. There's Women is One, which is also slightly commercial. So in a way, it would be good to have something that is kind of open. You don't even have to be an HRS member, I would think. ERA has a similar collection of names and topics. But it's important, I think, is to make that available for people who are program chairs, for people who are needing to fill a slot because someone has declined last minute. And that is, I mean, I'm sure it was a big headache, and it's terrible because you have to find a solution quickly. But it's also, I think, one of our, as we all sit here, our responsibility is to, if we decline for whatever reason, to say, but I propose X. Because you probably know who's doing, I do PFA ablations, I know who else does them, female. And then I should propose that name. Or if I am no longer able to, or my turn in the committee is up because the, whatever, my four, three years, my term is up, then I should propose to take one of my female colleagues. Just so to promote, so we need to, you know, that's what I meant with leaning in. We need to actively push for it because otherwise the answer is, oh, there was no female person that we could think of, and that's why it. Who manages the ERA database? So the ERA database, we had a committee at some point. That committee was not for a very long time. So at the moment, I think, I don't know if Andrea still has a copy, but Andrea was the program chair for ERA for the last two sessions. And I think she has- So she has a database of women. Of women. Of women. And is that database available to industry just in terms of thinking about industry needing to look for new site PI or new members for their DSMB? I don't know about the governance about that. So if that's possible, I think the French are very restrictive of what kind of data they share. So I feel that it's not open to industry. Well, you know, we have women with opinions on the panel, but I know that we have women with opinions in the audience too. So I, and men with opinions for that matter. So we would love questions. So, yeah. And I don't even think you need a mic. You did, we just- Questions or comments. Questions or comments. Yeah. Yeah. Pam, what are you gonna do when you go home? Anything differently based on what we have talked about today? Anne, could we have a session with industry representatives and hear from them on their Somebody brought that up before. It's sad. As I was putting together this program this afternoon, one of the things I thought about was having one of the panelists be somebody from industry. The problem came in. Who do you include? Who do you not include? We've got multiple device companies, we've got lots of pharmaceutical companies, so it just seemed easier not to, and I'd actually hoped that there'd be some representation here and get some input from them, but you're exactly right. I mean, I think you can't do this in a vacuum, and so we need to know from them what to do, and I do think it goes beyond, you know, I love our Women in EP program. Jodi and I are going to be starting to talk about the next one tomorrow, and so that's always good, but that's in a vacuum, right? And that only does so much, and that doesn't change the big thing. It does a lot. It does a lot. Well, it does a lot. That's what I'm saying. It may only do so much, but it does a lot. So well, thank you, and yeah, no, I think the idea that you get into a room and you see a bunch of women who look like you, you go, wow, like you said, I can do this, too, right? So I think that's been very powerful, but I think you make a good point, Pam, about the quota, and, you know, we put a woman on it, and we're done, you know, and move on to somebody else. You know, I've had a lot of opportunities, and I've always been pleased with that. Very frequently in any of those kinds of ad boards and all that, I'm the only woman there. Sometimes there's one other one, but you have to think, if I wasn't there, would anybody be there? And so it's—I think we have to—I do think we have to engage industry directly about this, and the question is how to go about doing it. And maybe that is something, you know, we're talking to a future president of HRS here down the end. You know, how do we actually hold that specific discussion about changing that paradigm? And it's a great question, and overall, you're going to have a unique opportunity of being president of HRS. What do you see that your role could be for women in EP and clinical trials? Yeah, absolutely. This is a big priority for me to support all members of HRS, but certainly to pay attention to the women, especially in relation to career opportunities, growth, what have you. So that's definitely something that is going to be on my radar my whole term as president-elect as well as president. But I absolutely would love us to continue to have this conversation and to be very concrete in terms of what the next steps will be, and I think one of the next steps, in my opinion, should be a conversation with our industry partners and whether this would be like a satellite meeting at one of the upcoming meetings, AHA, whatever, or at the next HRS meeting. I mean, I absolutely agree that we need to have that conversation with them, but a couple of other points. In terms of the action items, I absolutely encourage us to kind of agree on those before we leave today. The other thing that I would say is if we're going to have a white paper, I think, like we do with guidelines, you have the top 10 messages, top 10 lessons from it, because people are not going to read these long papers. So if we have one summary that has, okay, these are the 10 things that we want people to focus on, and then I think this will also help us focus our efforts and stay on the goal to be able to make some progress. So I think one very concrete thing that HRS could do in putting together a lot of what's been talked about and also sort of stemming from the conversation some of us had with one of the companies at, I guess it was AHA or ACC, would be to take that database that is sort of informal and it's a starting place, but it really isn't taking us all the way, and incorporating that into HRS and working with industry so that industry really could say, I'm having a meeting of X device, gosh, I don't know any women involved, like, you know, they could then go to that database. And I think working together with industry in a partnership like you just talked about, like have that roundtable. The Cordis woman earlier was like, how come, you know, you guys didn't have any industry members? We would have really liked to. And I think putting those people together and saying, hey, let's do this. This way you can, you know, I think that would be a concrete thing to do. Oh, that's a great suggestion. And as you know, there will be a couple of sessions on Saturday on the research network, and I think this is something that we need to at least explore in terms of how can HRS take this database to the next level. Good afternoon. Two comments. One is a broad one, which is this has been outstanding as a person who has been interested in training physician scientists my whole career at multiple different levels. And I hope something gets written from this that helps move the field in an objective way that people can read. And I would take this on a road show. I mean, this is so important as far as setting a similar thing up at the American Heart meeting, at the American College meeting, and keep hitting this, including national news, just to emphasize where we are and why and where we want to go. The second comment specific to this particular discussion, and I've been out of this loop for a long time, when I started the EP program in St. Louis in 1981, you know, there was no official GME programs, they were apprenticeships. GME required a two-year program that mandated that people produce research projects that are written up and get published. And that's much harder to do, but nevertheless, it is part of the broad GME program that people who are EP fellows need to be exposed to some type of research, and the quality of that varies across the programs. What I see it as a strategy for a little bit intermediate term positive results, and with you becoming president, is to put those program directors under the gun to do two things. You know, we demand that the culture change and that this be addressed as far as women and other underrepresented people having equal access to careers in clinical research and academic medicine. But the program directors can really drive that, and I would think it worth while to set up meetings with them to progressively emphasize this, and even if one could get at the national level to the GME, ACGME accrediting bodies, getting them to define what is meaningful research and put some objective metrics that graduating fellows need to accomplish, just to get research back into that training program. Great points, thank you. Hi. Hi, everyone. I really enjoyed, I came in late, but the bit that I've heard, I've really enjoyed it. I've been a beneficiary of, you know, a lot of leadership initiatives by HRS, and, you know, learned a lot, and am interested in research, and I found myself in my educational career, having not been in institutions that are really based in research and, you know, learning the nuts and bolts of research, you kind of have an idea of what to do to get to a certain level, but you don't really have the kind of nuts and bolts, and it seems like the programs that are available, for instance, the ACC program, they really emphasize that you have, like, institutional support. And what do you do for folks who maybe don't have an institution like that? Like, they're not in academia, but, you know, maybe they're in, you know, a hospital, or maybe they're even in private practice, but they're still interested in putting out quality research. How do they get involved in programs like yours? I guess I can start with that. So it's such an interesting point in terms of institutional support. I think certainly we see where that's coming from, at least for people who are involved in academia, academic environment, you need the institutional support to be able to do a program, and it's important to have the supervisor leadership's partnership in developing your growth. But your point is so well taken, because I actually think that's a loophole. I don't think there's a mechanism for people in private practice to opt into a program like I described. It simply just does not allow the application to be completed. So I think that institutional support probably needs to be more flexible. I think perhaps, you know, for people who are interested in doing clinical trials in the private practice setting, this is probably a feedback we can bring back to ACC, is maybe they ought to accept, you know, other forms of—it's simply an endorsement and letter from, you know, for example, from an elite partner of the practice or from some other mechanism that they have an understanding to permit that. Then I think the last part is probably even bigger of a loophole, which is what Sabine was getting at in terms of the open access. What if there are people who really want to do this, they have the drive, the motivation to do this, but they are not in a major academic center, they are not part of a large clinical practice, has someone vouched for them, but they still want to be part of it. Perhaps there still ought to be some mechanism, but then, you know, then we just need to figure out how then would that person get plugged in. And I think maybe part of what we are identifying is the issue of flexibility, that we need to be much more flexible in our mindset in terms of who we train, how we train, so that maybe we can actually engage a broader pool than we initially expected. Sabine? Just a quick comment here. I think the landscape is going to change. It's going to probably allow people like yourself to be far more involved because of connection and networking between, for example, mapping systems. So I use Carto a lot. CartoNet allows that kind of collaboration, you can upload your data to participate in even trials. At the moment, the companies are collecting the data and they kind of keep it for themselves, but I think we should go and take those and demand those, and there is a wavy initiative of Biosense where we try to do this. We are not very far with that yet, but we would, and that's a European initiative, so I'm sorry for that, but it could be copied and done here as well for fluoroscopy exposure. How are people using the system? What's the real-life scenario, for example? How do people, you know, reduce their fluoroscopy exposure? We wanted to do an educational initiative to say okay that's what we do and it's just a kind of a retrospective ad hoc what are people doing then we wanted to do an educational event online to say these are the tricks you know you can reduce your floor and by looking at this and change your whatever frame rate and stuff like that these are a couple of other tricks and then see if that has an impact on how people use it in the end is there any learning effect and and that was something where we wanted to invite everyone to participate so if you are connected by car to net then we could suck your data essentially into it so this kind of research I think will be coming more and more I'm sure the device companies will do similar things and that would be a platform where non-academic colleagues could participate and again you might be having a massive practice and that's why you know if you support a trial with massive data suck you in and and that's but we need to kind of also help with these kind of platforms thank you very much for your question I just want to put the plug in for a session that we're gonna have tomorrow speed mentoring it's called it's gonna be a roundtable in the exhibits from 130 to 230 where we have leaders in the field who will come and basically spend some time like five ten minutes with each person depending on how many people participate and you can ask any questions about like your career if you're interested in research even if they don't have the bandwidth to like work with you on research projects I know they can make some suggestions ideas that you can apply and then coming back to read to industry again this is where industry can be your friend also in private practice and there are two ways for that so you may be interested in in a specific component of you know something that Medtronic does as an example and you could write up you could suggest to them that I would like to look a little more closer at this and create the PA initial protocol and that is often a successful way of getting your foot in so you put a lot of dealers pacemakers and you know then then Medtronic and Abbott are gonna start paying attention to you because you are a good customer and good customers should be represented in upcoming clinical trials so the more you do something the more you should push you know go to Abbott go to the companies and say look at this this is what I do why can't I be part of it you know squeaky wheels it it works I would say I think success in research is about answering a question that you have like Rachel wanted to understand what about athletes in ICDs I mean she really wanted to understand that and because it was important to her she was successful at it so I think you know people say I want to be involved in research and that's one way to go but the other way is to think of a question you know I'm interested in device detected a fib you know what are we supposed to do when someone has ten minutes of a fib on their pacemaker like what does that mean and I care about that and so that makes me successful at that question you know what I mean so I think you need and that requires some time in your career to think about why you know what this makes no sense I want to understand it better that'll be a good question and you'll be successful answering it well I think we're coming to the end of this session and and we think would all love for and to put some closing remarks on the only good afternoon yeah thank you I think it is a good time for us to wrap up and thank you to the panelists and everybody who's participated here so so I you know as I told some people before I do not like walking out of these rooms and say boy wasn't that fun and go on and we live our lives and nothing changes so I made some notes here and I do think that you know it'll require follow-up after this meeting or else we won't get anything out of this and that would be a disappointment we don't want that so and some of the things I made notes of I'm gonna start out not that it's the most important but I don't want to forget it well we didn't talk about with the ACC clinical trials research program is that I went to Pam Douglas and I said why don't we have an EP cohort all right there was a structural heart cohort this year it was sponsored by by a company and she was very enthusiastic about it and immediately brought me the head honcho at ACC who would help find the funding for this and there's interest in it so the fourth cohort just ended there are no specific plans for the next cohort although there is interest in it my guess would be is that we're looking at next year to start it and when we say a cohort I don't you know the clinical trials research program tends to have about 50 people in it and it has been women and minorities we're not gonna find 50 women to fill an entire cohort here but one company's actually already committed to sponsoring 10 women they're already said they would do it could we get others to maybe get a little bit more we probably could I want quality you know so people who are really interested but that is a possibility an outcome that we would encourage a specific EP cohort in the next CTR program I think that the database that was talked about that Chris has done I think she's done an amazing job and it cannot get to where we need it to be if we're depending on one person to do all the work right it's just not gonna happen so is this something I do think we need to have industry weigh in as to how could we make this useful to them you know because if if we give them the data they want I think it could be more useful to even to HRS you know in years past when I put you know I don't know what your experience this year is sauna but I used to get so frustrated when I wanted to get more women in the program and I'd look at our database and I'd say okay I want to bring so-and-so in what's their area of expertise and it said electrophysiology you know which didn't mean no good whatsoever because I had no idea what it is they really wanted to talk about right so you need more like we said granularity was something that came up so that has to be done so we need to expand it improve it is this something that we that you know a staff person at HR else helps with 50% of the time and we get industry support for I don't know but something that makes that database really more useful leverage the women is one one bring it in I mean you know we look at everything that they've got you take the good you leave out the stuff we don't need and you adapt it for EP so I think that database is something that's got to be important important for us to use a session that we have with industry maybe at a future meeting would be one thing where we get into the more of this exactly how do we get that promotion of women into these leadership positions I think we need to leverage the research network that HRS is developing I hope to be able to attend at least one of those sessions on Saturday I don't think I can do both but you know I want us to think about how we leverage that for use we can write a white paper out of this you know as I always say if you're the chair or something you know what's gonna happen you're gonna wind up taking the lead on it so I'll think about it when I get out of here but I'm certainly willing to think you know for us to consider that Michael mentioned a roadshow I you know I can talk to him some more about that I know where he lives and so we can have that discussion I think your comments about the program directors are very interesting it's not something that we spoke about directly but I you know I think that culture change there are too many programs where it still feels like an old boys network and let's face I mean if we looked right now and said if there are women faculty in an EP program how many women do they train an EP versus programs that have none there's got to be a difference there right and and and some of that is a culture of feeling like you're included there that it's possible so I think understanding that from the program director standpoint and also the idea of getting more research back into EP training when it becomes all about doing the procedures we're not really encouraging people to really move the field as you like to say so I think those are to me those are sort of some what I'm thinking of is at least the beginning beginnings of concrete ideas and am I leaving something out I can somebody add anything that I haven't just mentioned here that I can put on my list and think about after we get out of here I think the research network and actual inclusion it may be part of that I'm not sure exactly the details there but involvement of you know leaders and then you know other you know co-co investigators as part of okay specific projects even starting with well yeah I mentioned that sort of a I know I just one of my dreams out of this too was was exactly that can we can we have a whether it's invest sort of investigator initiated industry sponsored trial that's multi-center where we emphasize the recruitment of site investigators who are women that it be 50% women not 5% women right and that's a matter of getting the right question and the right enthusiasm but I bet you if you said to women we were doing something like that you have a lot of them raising their hands you gotta produce you gotta do a good job we have support them to do it but you know for us to start thinking about what would that research question be and I just don't want it to be something that is only about women we don't want to pigeonhole ourselves like that we need broadly applicable questions that we can get so you guys can all help me think about that as we go forward I just want to say like when I see that HRS the speakers I think like 25 or 30 percent women or something like that but that's not the women that's not the number of electrophysiologists that are women so we're doing a good job here yes but we really need to do a better job getting the number of electrophysiologists to be 25 percent women so well I think that's where the program director thing comes in about how they're thinking about that I mean I trained a bunch of women in EP right you know and you know and it was a it was a pretty good percentage but again people saw that you know I had a family and I managed it and so we worked you know so other ones got in and did it so okay okay all right so anybody has ideas coming out of here afterwards that you think about as you go back to your hotel room you know you can email me you know how to find me I want to express my appreciation so much for everybody who participated here today you stuck it out until the end we appreciate Cordis's support for this we are not done this is just the beginning of something so thank you all and plenary sessions tomorrow Sana a great meeting and looking forward to spending the rest of the week next three days with everybody so thank you I do want to say thank you to end though this is this was an session
Video Summary
This session focused on identifying and addressing gender inequality in cardiovascular clinical trials and leadership, particularly concerning women in electrophysiology (EP). The event featured a comprehensive agenda that included statistical assessments, barriers to participation, and actionable solutions for improving gender representation.<br /><br />Key problems discussed included the low percentage of female cardiologists, particularly in EP and interventional cardiology, and the even more limited presence of women in leadership roles within clinical trials. Institutional barriers such as lack of funding, mentorship, and protected research time were highlighted as significant obstacles. Personal barriers noted were the lack of visibility and opportunities compared to male colleagues.<br /><br />To address these issues, the session proposed several solutions:<br /><br />1. Institutional Support: Emphasize the need for academic institutions to prioritize diversity in clinical trial leadership and provide structured mentorship and career development for women in research.<br /><br />2. Industry Collaboration: Engage industry stakeholders to ensure equal opportunities for women scientists in clinical trial leadership. Leverage existing databases to identify qualified women for these roles, and consider developing new ones to enhance visibility and connection to opportunities.<br /><br />3. Building Networks: Encourage women to partake in affinity groups and databases, such as Women as One, to facilitate networking and mentorship. Consider creating EP-specific initiatives to support women researchers.<br /><br />4. Innovative Programs: Promote programs like the ACC Clinical Trial Research Program to train women in clinical trials, potentially developing EP-specific cohorts supported by industry sponsors.<br /><br />These discussions aim to instigate an environment where women's participation in clinical trials is normalized and equally valued, advancing both scientific research and patient care.
Keywords
gender inequality
cardiovascular clinical trials
women in electrophysiology
female cardiologists
leadership roles
institutional barriers
mentorship
diversity
industry collaboration
networking
Women as One
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clinical trial research
EP-specific initiatives
patient care
Heart Rhythm Society
1325 G Street NW, Suite 500
Washington, DC 20005
P: 202-464-3400 F: 202-464-3401
E: questions@heartrhythm365.org
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