What Are the Trends in Women's Representation Among Principal Investigators of US Clinical Trials in the Field of Genetics?

INTRODUCTION

Despite progress in the representation of women in the medical profession, substantial gender disparities persist in leadership roles, particularly in clinical trials. Clinical trials are crucial to evidence-based medicine, offering visibility, career advancement, and future funding opportunities for principal investigators (PIs). However, women remain underrepresented in these roles, especially in genetics. This study aimed to evaluate (1) the proportion of women PIs in genetic clinical trials and its change over time, (2) trial characteristics (phase, funding source, intervention type) associated with women PIs, and (3) the geographic distribution of women-led trials in the United States.

METHODS

We analyzed 4,112 genetic clinical trials conducted in the United States and registered on ClinicalTrials.gov between 2007 and 2024. Trials lacking defined phases or complete investigator information were excluded. Statistical analyses were conducted using Fisher's exact tests and univariate linear regression.

RESULTS

Women comprised 1,552 out of 4,112 (37.7%) PIs, with representation fluctuating from seven out of 24 (29.2%) in 2008 to a peak of 17 out of 29 (58%) in 2010 before leveling off to 573 out of 1,712 (33%) in 2024. Women PIs conducted a higher number of behavioral (240 out of 1,552, 15.5%) and other interventions (218 out of 1,552, 14%) studies, compared to 196 out of 2,560 (7.7%) and 222 out of 2,560 (8.7%), respectively, for men. On the other hand, men PIs had a higher number of genetic (111 out of 2,560, 4.3%) and drug (1,654 out of 2,560, 64.6%) trials, compared to 44 out of 1,552 (7.7%) and 841 out of 1,552 (54.2%), respectively, for women. Women received more federal funding (24 out of 1,552 (1.5%) vs. 17 out of 2,560 (0.6%)), while men dominated industry funding (695 out of 2,560 (27.1%) vs. 386 out of 1,552 (24.9%)).

CONCLUSION

Women remain underrepresented as PIs in genetic clinical trials, with no sustained growth over time. Mentorship programs, equitable funding policies, and increased visibility of women researchers are essential to address these disparities and foster equity in clinical trial leadership.