Women Are Unequally Represented Among Clinical Trial Leadership by Orthopaedic Subspecialty

Abstract

Background: Although men substantially outnumber women in orthopaedic surgery, prior studies have demonstrated that authorship disparities persist even after adjusting for this imbalance. If comparable patterns occur in clinical trial leadership, they may hinder women's academic advancement in our field. However, to our knowledge, no studies to date have examined proportional representation in this context.

Questions/purposes: (1) Does the proportion of woman-led clinical trials differ among orthopaedic subspecialties? (2) Are women proportionally represented as PIs after adjusting for the percentage of women in each specialty? (3) Is the proportion of woman-led orthopaedic clinical trials associated with other characteristics, such as trial location or type of intervention?

Methods: A retrospective analysis of orthopaedic surgery clinical trials registered on ClinicalTrials.gov from 2007 to 2025 was performed. Trials were manually reviewed for subspecialty relevance and PI identity. PI gender was determined via genderize.io, a validated online application that assigns a predicted gender to user-input names. Trials without orthopaedic surgeons as PIs and those with low-confidence gender predictions via genderize.io were excluded. Of the trials initially identified, 26% (1510 of 5842) met inclusion criteria, of which 55% (837 of 1510) were US-based and 42% (637 of 1510) were international studies. Chi-square tests were used to compare the proportion of women PIs across nine orthopaedic subspecialities and five intervention types (procedural, device, drug, behavioral, and other). Chi-square tests were also used to compare representation in trial leadership across regions within the United States and across continents. A US-specific analysis utilized prevalence to participation ratios (PPRs) to assess whether there was equitable representation of women among trial leadership after normalizing to the underlying proportion of women surgeons in each subspecialty. These proportions were obtained by reviewing public websites to identify academic surgeons at institutions affiliated with orthopaedic residency programs. Subspecialties were considered to have underrepresentation of a gender when that gender led less than 80% of the trials expected based on its share of the workforce (PPR < 0.80) and overrepresentation when a gender led more than 120% of the expected trials (PPR > 1.20).

Results: Gender representation among trial leadership varied by subspecialty (p < 0.001), with pediatric orthopaedic trials demonstrating the highest proportion led by women (20% [19 of 95]) and sports medicine demonstrating the lowest (4% [7 of 172]). After adjusting for the underlying demographics of each subspecialty's workforce, women were proportionally underrepresented in foot and ankle (PPR = 0.20), trauma (PPR = 0.51), pediatrics (PPR = 0.58), hand (PPR = 0.38), shoulder and elbow (PPR = 0.795), oncology (PPR = 0.72), and sports medicine (PPR = 0.71) trial leadership. Women were overrepresented among trial leadership in spine (PPR = 1.27) and proportionally represented among hip and knee (PPR = 0.83) trial leadership. Gender representation varied by world region (p = 0.02), with Europe showing the highest proportion of women investigators (12% [45 of 378]) and "Other" regions (that is, those outside of Europe, Asia, and the Americas) showing the least (0% [0 of 27]). Representation also differed by study intervention (p < 0.001), with behavioral intervention trials having the highest proportion of women PIs (29% [12 of 41]) and device trials having the lowest proportion (6% [22 of 373]), and by study type (p = 0.03), as observational studies included a greater proportion of woman-led trials (11% [41 of 380]) than interventional studies (7% [82 of 1130]).

Conclusion: As proportional underrepresentation of women in trial leadership is concentrated in specific subspecialties, PI development initiatives in these areas may have greater impact than generic, field-wide efforts. Understanding why some subspecialties have achieved proportional representation whereas others lag behind should be a priority for future work, as fields with proportional or higher-than-expected representation may provide models worth emulating.

Clinical relevance: Improving the proportional representation of women in trial leadership roles ensures that research leadership in orthopaedics reflects the gender diversity of our workforce and our patients. Doing so may also help strengthen the academic pipeline for women orthopaedic surgeons.

Trial registration: ClinicalTrials.gov NCT identif.