A new study led by scholars at Stanford University has found that women principal investigators of clinical trials are more likely than their male counterparts to include women in their studies.
The research team examined 10,708 clinical trials from 2007 to 2021 to analyze how the proportion of women participants in clinical trials varied by principal investigator gender. Less than 30 percent of principal investigators included in the study were women. Typically, trials that were led by a woman were larger, conducted at fewer trial sites, were less likely to involve phase 3 or phase 4 trials, reflected similar disease areas, and had a high proportion of women participants.
The mean enrollment of women in trials with a woman principal investigator was 54.1 percent, compared to 46.9 percent for trials led by a man. Trials led by women were also less likely to exclude pregnant women from participating, with 48.2 percent of women-led trials excluding pregnant patients, compared to 53.0 percent of those led by men.
Additionally, women-led clinical trials were significantly more likely to employ other women. In trials led by a woman principal investigator, 73.6 percent of listed site coordinators or facility investigators were also women. For trials led by men, women represented just 35.7 percent of research staff.
“These findings suggest that one way to improve patient representation in clinical trials and, importantly, to improve the foundation of evidence on which medical decisions are made for diverse populations would be to increase the diversity of clinical trial investigators,” the authors conclude. “Inequity in clinical trial enrollment of women is a critical concern in medicine, in part because medical care provided to women today may lack the same level of evidence generated for other populations.”