Wide gender gap in authorship of cardiovascular clinical trials
Women are grossly underrepresented in leadership of cardiovascular clinical trials, making up only 9.3% of first authors and 10% of senior authors. In addition, they account for only 10.1% of trials’ leadership committee members, according to a study led by Cleveland Clinic cardiologists.
These percentages can’t be considered surprising, given that women represent only 12% of board-certified cardiologists, 7.2% of interventionalists, and 6% of electrophysiologists.
Yet, despite the known disparity of women in cardiology, “women’s representation in clinical trial leadership is still much lower than would be expected,” said Leslie Cho, MD from the Women’s Cardiovascular Center at Cleveland Clinic, and co-author of the study, which was presented by Kara Denby, MD, also from Cleveland Clinic.
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 (n = 41), The Lancet (n = 70), and The New England Journal of Medicine (n = 89). After excluding trials that focused on emergency medicine, 200 trials were included in the analysis.
Across all three journals, women accounted for only 9.3% of first authors and 10.0% of last authors.
“Women were far underrepresented on leadership committees — and women physicians [in contrast to nonphysician scientists] even more so,” said 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).
Five percent of committees had 25% or fewer members who were women and 5% of committees had no women members.
“We didn’t look into why these disparities occur, but other studies have suggested possible explanations,” said 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. 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, a recent study reported fewer deaths among women with myocardial infarction 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.”
These findings suggest that women may bring unique perspectives and insights to cardiovascular research and clinical trials in a diverse patient population, according to the authors.
The researchers also call for action to address the disparities now. Dr. Cho noted 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.”
An abundance of data suggests that having diverse representation improves quality of care as well as research, Dr. Cho added. “Perhaps with increased representation of women in trial leadership, we can finally have better representation of female patients in clinical trials,” Dr. Cho observed. “The best way forward is for the field to acknowledge that such disparity exists and actively work to overcome the disparities with action.”
A version of this story appears in ConsultQD.