Review of Cardiovascular Clinical Trial Leadership Shows Disproportionately Low Number of Women

February 28, 2022—The American College of Cardiology (ACC) announced that a review published by Mary Norine Walsh, MD, in Journal of the American College of Cardiology found that women remain underrepresented in leading cardiovascular clinical trials, which corresponds with underrepresentation and a lack of gender diversity among presenters at scientific meetings (2022;79:929-932).

According to the ACC press release, a previous analysis of cardiovascular trials published during the last 4 years found that women comprised 10.1% of clinical trial leadership committees, and more than half of the trials had no women as part of the trial leadership team. Other research has also found a correlation between women leading clinical trials and the number of women participating in clinical trials. Historically, clinical trials have largely enrolled White men, and participation has been low among women, older adults, and racial/ethnic minorities.

The current review highlights the gender diversity of panelists and session chairs at the recent ACC Scientific Sessions but demonstrates that 93% of the clinical trial results were presented by men.

“These problems are, unfortunately, cyclical in nature,” commented Dr. Walsh in the ACC press release. “A lack of women in leadership positions on clinical trials results in fewer women participating in the trials. The fewer women participating in studies means that medications and other therapies aren’t ensured to be safe and effective for everyone. Fewer women leading clinical trials also means fewer women presenting pivotal, practice-changing trial results at scientific meetings.”

Dr. Walsh, who is Medical Director of the Heart Failure and Cardiac Transplantation programs and the Cardiovascular Research Institute at Ascension St. Vincent Heart Center in Indianapolis, Indiana, further stated that increasing the number of women on trial steering committees needs to start at a deeper level, including mentorship in early career and fostering knowledge of clinical trial committee structure.

She noted that to help ensure this, medical societies have begun to release recommendations and roadmaps to foster change, such as the ACC’s “Clinical Trial Research: Upping Your Game” program, designed to help develop and train the next generation of women and underrepresented minorities as clinical trialists.

“We’re starting to see work being done to close the gap in representation, but more needs to be done,” advised Dr. Walsh. “Scientific sessions and meeting planners only have so much influence over who is presenting at conferences. This comes down to senior clinical trialists relinquishing the podium and giving a leg up to others.”

The ACC press release outlined Dr. Walsh’s recommendations to increase representation in clinical trial leadership as follows:

• Federal and industry sponsors of clinical trials need to insist on diversity of the trial steering committee.
• Investigators asked to lead clinical trials must consider geographic, institutional, and trial site diversity, along with a diverse slate of experienced investigators in leadership positions.
• Institutions, department chairs, and division chiefs need to encourage women to serve as site principal investigators.
• The informal or formal pecking order of cardiovascular trial leadership needs to be reworked.
• Women should not only be tapped for clinical trial leadership and reporting late-breaking results when the trial is pertinent only to a female patient population.

“There will be no room at the top for new and innovative investigators to shine if those who have already achieved success don’t make room,” Dr. Walsh concluded.

The ACC press release noted that more information on increasing diversity in clinical trial participants is available at www.cardiosmart.org/clinicaltrials.