Trends in Women's Representation Among Principal Investigators of Clinical Trials in Orthopaedic Sports Surgery.

Abstract

<h4>Background</h4>Women are underrepresented in academic positions, authorship roles, and award recognition within orthopaedic sports surgery. We aimed to determine the extent of this disparity within clinical trial leadership.<h4>Hypothesis</h4>it was hypothesized that women would be significantly underrepresented as principal investigators (PIs) of clinical trials, but that this disparity would decrease over time.<h4>Study design</h4>Cross-sectional study.<h4>Methods</h4>The Clinicaltrials.gov database was queried using Medical Subject Headings terms to identify studies regarding orthopaedic sports surgery. A variety of trial characteristics were recorded, including PI gender, trial phase, study design, date of posting, location, and enrollment. Our primary outcome was the proportion of women PIs compared between 2005 and 2025. Secondarily, we analyzed geographic distribution across world regions, countries, states, and the United States (US) Census regions, as well as trial characteristics (phase and intervention). Frequencies and percentages were used to demonstrate women's representation within each of these variables, and chi-square tests evaluated associations between trial characteristics and gender. Logistic regression was performed to assess trends in representation over time. A representation quotient was calculated comparing the proportion of women PIs with the proportion of women sports surgeons in the US.<h4>Results</h4>Overall, 64 of 377 (17%) trials within our sample were led by women. The number of women-led clinical trials increased at a mean annual rate of 0.83% from 2005 (0/2; 0%) to 2025 (3/5; 60%); nonetheless, this change was insignificant (<i>R</i> ² = 0.13; <i>P</i> = .11). PI gender was not significantly associated with US census region (<i>P</i> = .15) but was significantly associated with world region (<i>P</i> < .001). Representation was lowest in North America (23/216; 10.6%) and South America (0/6; 0%). Among countries, Australia (1/1; 100%), Portugal (2/2; 100%), and Pakistan (4/5; 80%) had the greatest representation. Gender was also not significantly associated with study phase or study status. For trials involving procedures, women had a greater proportion of leadership roles (21/77; 27.2%) than the overall sample. A representation quotient comparing the proportion of women PIs (0.11) with the proportion of women orthopaedic sports surgeons (0.06) in the US was 1.79.<h4>Conclusion</h4>A small proportion of orthopaedic sports medicine clinical trials are led by women. However, women may be overrepresented in leadership roles in clinical trials compared with their representation in orthopaedic sports medicine.