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…
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