Gender Disparity Greater Than Expected in Leadership of Cardiovascular Clinical Trials

Study is the specialty’s first to quantify lack of women authors, committee members

In leadership of major cardiovascular clinical trials, the gender gap isn’t just large — it’s expansive. Women make up only 9.3% of first authors and 10% of senior authors. And they account for only 10.1% of trials’ leadership committee members, according to a recent study led by Cleveland Clinic cardiologists.

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That may be no surprise, given that women represent only 12% of board-certified cardiologists, 7.2% of interventionalists and 6% of electrophysiologists.

“Despite the known disparity of women in cardiology, women’s representation in clinical trial leadership is still much lower than would be expected,” says Leslie Cho, MD, co-Section Head of Preventive Cardiology and Director of the Women’s Cardiovascular Center at Cleveland Clinic.

Dr. Cho is senior author of the study, the first to quantify the gender disparity in clinical trial leadership with a specific focus on cardiology. First author Kara Denby, MD, a cardiovascular medicine fellow at Cleveland Clinic, presented the study at the virtual meeting of the American College of Cardiology.

200 trials reveal stark underrepresentation

The researchers identified and evaluated all cardiovascular medicine studies published from 2014 to 2018 in three high-impact journals: Journal of the American Medical Association (JAMA), The Lancet and The New England Journal of Medicine (NEJM). After exclusion of trials focusing on emergency medicine, surgery and cardiac anesthesia topics, 200 trials were included in the analysis.

When tallying the gender of first and senior authors of these 200 studies, the researchers found that women represented:

  • 3% of first authors
  • 10% of senior authors

When tallying the gender of the trials’ leadership committee members, they found that:

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  • 5% of committees had 25% or fewer members who were women
  • 5% of committees had no women members

“Women were far underrepresented on leadership committees — and women physicians [in contrast to non-physician scientists] even more so,” says Dr. Cho. “Only 5% to 6% of committee members were women physicians, and the majority (55.5%) of committees did not include any women physicians.”

Women leaders were even rarer in large trials (those with > 500 enrollees) and in studies of procedural subspecialties (electrophysiology and interventional cardiology) versus nonprocedural subspecialties (clinical cardiology, cardiovascular imaging, heart failure, preventive cardiology and vascular medicine).

Nearly half of large cardiovascular trials did not include any women in any leadership position.

What causes the gender gap?

These findings echo the underrepresentation of women in clinical trial leadership across other medical specialties. In an obstetrics and gynecology study, for example, women were found to make up 58% of faculty positions but only 28% of senior authors.

“We didn’t look into why these disparities occur, but other studies have suggested possible explanations,” says Dr. Denby. “There could be an unconscious bias that results in inadvertent gender discrimination. Maybe it’s due to less industry recognition, slower rates of promotion or lower grant funding for women. Maybe it’s a cyclical problem, where having fewer women leaders leads to fewer women leaders being developed for the future.”

The issue is likely multifactorial, she notes.

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Why this matters

The authors advocate further research on the issue, particularly in light of evidence of at least moderately improved patient outcomes when women physicians are involved in care.

For example, one recent study reported fewer deaths among women who had a heart attack when they were treated by a woman physician. Similar findings were reported in studies of elderly internal medicine patients and emergency department patients treated by women physicians or a combination of women and men physicians.

Another study found that research quality is better when trials have first and senior authors of different genders,” says Dr. Denby. “With that in mind, the cardiovascular medical community may have an opportunity to strengthen its research by significantly increasing women’s inclusion in clinical trial leadership.”

The researchers also call for action to address the disparities now. Dr. Cho notes that this study’s findings parallel a well-recognized underrepresentation of female patients in clinical trials. “When the FDA looked at this,” she says, “they noticed that women were not even screened at similar rates even though they have a similar incidence of disease.”

She adds that an abundance of data suggests that having diverse representation improves quality of care as well as research. “Perhaps with increased representation of women in trial leadership, we can finally have better representation of female patients in clinical trials,” Dr. Cho observes. “The best way forward is for the field to acknowledge that such disparity exists and actively work to overcome the disparities with action.”