Why More Women Should Lead Clinical Trials
by Adrienne Mueller, PhD
March 24, 2023
Although trials with female principal investigators are associated with greater recruitment of female patients, the proportion of clinical cardiovascular trials led by women has not increased over the past decade.
In a study led by Celina Yong, MD and Paul Heidenreich, MD that was recently published in the Journal of the American College of Cardiology, a team of cardiovascular researchers reviewed gender representation across a decade of clinical trials. Dr. Yong and her collaborators reviewed cardiovascular clinical trials that were conducted between 2010 and 2019 and registered on clinicaltrials.gov – a national website that all US clinical trials are required to register with. The investigators reviewed 620 cardiovascular clinical trials performed over a 10-year period and identified whether or not each trial enrolled female participants, what type of study was being conducted, and, using a software tool, the gender of the principal investigators who led the studies.
The team found that when female principal investigators (PIs) led studies, those studies were significantly more like to enroll female participants. 44.9% of studies led by women enrolled women, whereas 37.9% of studies led by men enrolled women.
Between 2010 and 2019, only 18% of cardiovascular clinical trials are led by women.
In total, only 18.4% of clinical trials were led by women; although studies funded by the National Institutes of Health were significantly more likely to be led by women than studies funded by industry groups (28.9% vs 14.7%, respectively.) The investigators also found that there was no significant change in PI gender over time; suggesting that there has been no progress in gender representation in clinical trial leadership over the last decade.
Importantly, this study found that women PIs are more likely to enroll female participants, suggesting an important target for improving diversity of clinical trial enrollment.
Examples of clinical areas with the lowest representation by women include interventional cardiology and electrophysiology, in which only 8-9% of clinical leadership positions are occupied by women.
Addressing this underrepresentation – in PIs and among enrolled trial participants - will provide at least two major benefits. First, better representation of women leading cardiovascular studies promotes justice and equity in our profession. Second, cardiovascular studies that recruit more women participants will produce better data about the effect of their proposed clinical therapies on half our population.
Additional Stanford Cardiovascular Institute-affiliated investigators who contributed to this study include Aashna Suvarna, Robert Harrington, and Santosh Gummidipundi.
Celina Yong, MD
Paul Heidenreich, MD