Women remain significantly underrepresented in trial leadership roles for interventional structural heart disease (SHD) trials, according to a new study.

Less than 10% of committee seats in interventional SHD trials are held by women, while men make up more than half of committees, said Mayra Guerrero, MD, in the Department of Cardiovascular Medicine at Mayo Clinic in Rochester, Minnesota.

“Women in the US have historically been underrepresented in cardiovascular medicine, particularly in interventional cardiology,” she said. “As a consequence, critical gaps remain, including limited representation of women in leadership roles in cardiovascular clinical trials.”

Guerrero and colleagues sought to address the lack of representation in trial oversight committees, leadership roles, and authorship of critical interventional SHD trials. A co-author of a systematic review and meta-analysis, Guerrero said the goal of the study team was to generate contemporary data on women’s presence in these leadership positions.

The study, published in JACC: Advances, showed that despite growing awareness and clear proposals for improvement, gender disparities in trial leadership remain.

The researchers used data form 88 eligible trials, where 67.8% of the trials had a steering committee and 55.8% reported committee member names. For trials with available committee membership, women held just 7.0% of committee seats, whereas men made up 56.2% of committees.

“Despite the remarkable advances in SHD interventions over the past 20 years, and the growing number of clinical trials that have shaped clinical practice and guidelines, the representation of women in trial leadership roles has not increased at the same pace,” Guerrero noted. “That persistent gap was one of the most striking findings in our study.”

Sahar Samimi, MD, an internal medical resident at Baylor College of Medicine in Houston, agreed, especially since the number of women entering cardiovascular and interventional cardiology training during that period has increased.

“This doesn’t detract from the enormous contributions of investigators who have built the structural heart evidence base,” said Samimi, lead author of the study. “It suggests that growth in the broader cardiovascular workforce has not yet translated into similar changes in trial leadership.”

Previous research has shown that trials with women in leadership roles registered greater proportions of women, Samimi said. “Inadequate enrollment of women, as well as all demographic groups, can limit how confidently trial results can be applied across the variety of patients we treat,” she said, adding that it may leave important differences in efficacy, safety, anatomy, or outcomes unanswered.

Why Such a Gap?

The reasons behind the gap are likely multifactorial, Guerrero said. Not only do women remain greatly underrepresented in interventional cardiology but also few women perform SHD interventions, she said. “Only 3.9% of TAVR operators in the US are women and that figure includes surgeons. Only 2.2% of mitral TEER operators are women. Beyond the limited pipeline, lack of mentorship, sponsorship, and opportunities to assume leadership roles may be among the most important factors affecting the relatively small number of women currently in the field.”

Guerrero pointed out that greater diversity among trial leaders may contribute to study populations that more accurately reflect the needs of patients and ultimately improve the generalizability of clinical trial findings.

The long-term lack of diversity shapes which questions get asked, how patients are recruited, which endpoints are chosen, and how findings are interpreted, said Roxana Mehran, MD, director of Women’s Heart and Vascular Center at Mount Sinai Heart in the Icahn School of Medicine in New York City.

The small percentage of women who are practicing interventional cardiologists in the US inherently limits the pool of future trial leaders, said Mehran, lead author of an accompanying editorial.

“The imbalance is driven by structural barriers, limited parental support, gender bias, radiation concerns, fewer mentorship and sponsorship opportunities, and work-life challenges that can deter women from entering procedural fields in the first place,” she said.

Broader Focus Needed

The trial leaders, not the participants, determine the trajectory of research, Mehran pointed out, adding that, “When leadership is narrow, the science narrows with it.”

Major evidence gaps, she continued, still exist in cardiovascular conditions that disproportionately affect women, such as Takotsubo syndrome, myocardial infarction with nonobstructive coronary arteries, and spontaneous coronary artery dissection. A diverse leadership, she said, is more likely to prioritize these conditions.

Professional societies, regulatory agencies, academic institutions, and industry partners can all play a role by establishing opportunities that promote diversity in clinical trial leadership, the study team acknowledged, adding that the selection process for leadership positions needs to be more transparent.

Mehran said that while the emphasis of the study focused on sex-based disparities, race, ethnicity, and geographic and international representation deserve the same attention.

“This is not simply a matter of fairness,” she said. “It is essential for advancing the field while making innovation inclusive, representative, and broadly applicable.”

Guerrero reported receiving institutional research grant support from Edwards Lifesciences.

Mehran reported receiving institutional research grants from Abbott Laboratories, Abiomed, Applied Therapeutics, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Medtronic, Novartis Pharmaceuticals, and OrbusNeich. She also reported receiving a number of consultant fees and being associate editor for both American College of Cardiology and American Medical Association.

Samimi reported having no relationship to disclose that is relevant to the study.

Martta Kelly is a medical journalist who lives in the New York metropolitan area.