Women comprise 10.1% of CV clinical trial leadership

Erin D. Michos, MD, MHS, FACC, FAHA, FASE, FASPC

Randomized clinical trials are the best evidence base we have for supporting guideline recommendations that are implemented in the clinical care of patients. These are such important studies for how we ultimately deliver care for both female and male patients.  Unfortunately, this latest study continues to document that women’s voices are devoid in the design, conduct, and dissemination of these pivotal trials.

In this study, Denby and colleagues examined more than 200 CV clinical trials between 2014 and 2018 published in high impact journals like the NEJM, JAMA and The Lancet but unfortunately found that trial leadership consisted of only 10% women, and, dismally, more than half (56%) of committees had no women on them at all. Clinical trials tend to be highly cited (and citation counts drive the H-indexes key to academic promotion). Yet only 9% of clinical trial publications had a woman first author and only 10% had a woman last (senior) author.

I would say that the findings are very shocking, except I am not shocked at all given all the other overwhelming evidence that women cardiologists and clinical investigators continue to be lacking in almost all spaces of key leadership in cardiology.

There are many barriers that limit the advancement of women, and one major barrier is implicit bias that leads to the subconscious devaluation of women’s professional work. Unfortunately, there is evidence that women’s accomplishments are not as recognized as often as men. Women are disproportionately represented at lower faculty ranks across academic medical institutions, and women are less likely to be promoted to full professor even after considering similar professional metrics like publications and grants (Carnes M, et al. Circulation. 2017;doi:10.1161/CIRCULATIONAHA.116.026671). And women are less likely to be funded in the first place. For example, a prior study examining gender gaps in grant funding found that women were less likely to be funded due to less favorable assessments of their competency as principal investigators and not the quality of their proposed research (Witteman HO, et al. Lancet. 2019;doi:10.1016/S0140-6736(18)32611-4). Women are less likely to be invited for speaking at key scientific conferences for professional advancement. Women are underrepresented on editorial boards and in academic leadership such as division chiefs, department chairs and deans.

This underrecognition of the talent and accomplishments of women in turn can contribute to them being overlooked for inclusion in clinical trial leadership too. Unconscious stereotypes of what a CV trial investigator should look like may determine who ends up getting to be mentored, sponsored, promoted, funded, included and offered leadership, and women in cardiology are trailing behind the men.

Some of it may be lack of opportunity. Women’s professional networks often include less men, and women faculty are less likely to change jobs, meaning their networks have less collaborators from prior institutions of employment. In their discussion of their paper, Denby and colleagues refer to the vicious perpetuating cycle of how initial exclusion of women in cardiology at all steps of academic career just leads to further exclusion, lack of recognition of their competency and accomplishments, slow rates of promotion and further reduction in opportunities to be considered for key leadership roles. We need to break this unfortunate cycle and we need a transformative change to break it now.

These findings are not just unfortunate for women cardiology professionals — they suggest a loss for our patients too. Visibility of women in these key leadership roles of clinical trials can enhance recruitment of more women participants into trials.

We have previously shown that there was a continued underenrollment of women patients into cardiovascular CV trials of lipid-lowering medications (Khan SU, et al. JAMA Netw Open. 2020;doi:10.1001/jamanetworkopen.2020.5202) and of trials of cardiometabolic drugs used to support FDA approval for new molecular entities (Khan MS, et al. J Am Heart Assoc. 2020;doi:10.1161/JAHA.119.015594). Again, these are the trials that are used to drive clinical practice in the care of patients. Yet, women patients were underenrolled in these trials relative to their disease burden in the population, particularly for acute and stable CAD and HF, with a participation-to-prevalence ratio of less than half.  

Furthermore, another paper recently showed that there were few women authors of key publications of HF trials and practice guidelines, yet a higher number of women authors was associated with a greater enrollment of women patients in these HF trials (Reza N, et al. Circ Heart Fail. 2020;doi:10.1161/CIRCHEARTFAILURE.119.006605).

Women participants may be more likely to enroll in trials that they know are being conducted by women investigators. Women clinical investigators may be more likely to design trials in ways that are more accommodating to women participants, considering caregiver responsibilities, transportation and other barriers that would otherwise impede their participation in trials. We need to do better with enrollment of people from historically underrepresented groups as well into trials, and trials need to be designed in culturally sensitive ways. Thus, we need women leaders on trial committees to be part of these “think tanks” in designing clinical trials. Diversity in science leads to better science.  

So, we are losing out on both ends. We are losing by not tapping into the talent pool of our women scientists/clinical investigators and losing out by potentially underenrolling women patients in these trials, which results in a loss of understanding of the efficacy and safety of drugs and interventions in this subgroup.

Additionally, and also critically, the visibility of women leaders in trial committees can attract more women who are in training and in their early careers to pursue CV clinical research. The negative downstream impact of ignoring women in clinical trial leadership can have lasting consequences for the next generation of potential trial leaders; that is why there is urgency to end this gender disparity now and have CV research be a more inclusive space.

Maybe women early in their careers are unsure how to get involved in clinical trial research. I think that it is very important that there be mentorship and training of women early career cardiologists in clinical trial conduct, and I will point out that the ACC Diversity and Inclusion Task Force runs a course called “Clinical Trials Research: Upping Your Game” specifically for training in this area. As stated as their core objective, this program was designed to increase the number of individuals historically underrepresented in cardiology (such as women) to serve as future leaders in cardiovascular clinical trials research.

There should be absolutely no reason to have a trial steering committee with 0% women;  this should be scrutinized by the sponsor/funding agency. Multiple stakeholders need to take responsibility in promoting inclusive science.

I also discourage journals from publishing MANuscripts — papers with long list of male authors and no female authors (or a paper with just a single token female author). If authors knew that journals would not accept such papers, then they might be more thoughtful in thinking outside the box about who they invite as author colleagues to improve the diversity of their research teams.

Fortunately, there are some positive examples of journals who made substantial strides in their editorial team by pledging to develop processes to improve equity in journal leadership, peer review and authorship. And with such thoughtful determination, these journals were able to improve their statistics, Journal of Hospital Medicine being one such example (Shah SS, et al. J Hosp Med. 2020;doi:10.12788/jhm.3522). The Lancet also took a diversity pledge for their editorial team (The Editors of The Lancet Group. Lancet. 2019;doi:10.1016/S0140-6736(19)31797-0).

We still have a long way to go in cardiology. Despite women representing approximately half of medical students and 40% of internal medicine residents, women made up only 21% of cardiology fellowship trainees in 2017-2018, with only a modest increase over the prior decade (Khan MS, et al. Circulation. 2020;doi: 10.1161/CIRCULATIONAHA.119.044693). Encouraging women from medical school towards careers in cardiology and ultimately into senior cardiology leadership roles requires patching up the broken pipeline in multiple places. Improvements in the visibility of women as cardiology role models, sponsorship and networking early in the careers of women can help bridge the gender gap.

Representation matters and it matters a lot. It matters everywhere. The consequences of not having a diverse workforce are quite drastic because our patients are diverse, and we need to provide the most culturally sensitive care for them. Our workforce should represent the patients we care for. By not including women in leadership of clinical trials, we are not tapping into the full pool of talent. This jeopardizes everything in the cardiology field, including future research and generating the highest quality of clinical care, teaching, research and patient care. The costs associated with lack of equity and diversity are a loss to health care and to science. The benefits of diversity and inclusion are enormous: Trial designs would benefit by including the expertise of experienced and accomplished women clinical investigators in trial committees, likely there would be an increased enrollment of women participants in trials and the next generation of future trial leaders might be inspired.