Women's Representation as Principal Investigators Among Pediatric Orthopaedic Clinical Trials: An Analysis of ClinicalTrials.Gov

Abstract

Introduction: Despite recent efforts to increase the participation of women in orthopaedic surgery, there remains a gender gap, particularly when compared with other medical specialties. Acting as a principal investigator (PI) in a clinical trial can give physicians notable exposure and national recognition, which can improve their chances of promotion and tenure. This study aims to assess the proportion of women serving as PIs in pediatric orthopaedic clinical trials, examine associated trial characteristics, and explore geographic distribution. Methods: A cross-sectional analysis of clinical trials was conducted using data from the ClinicalTrials.gov registry. Specific search terms were used to identify pediatric orthopaedic trials. Data on trial characteristics, including phase, status, funding source, and intervention type, were collected. PI sex was determined using Genderize.io, an application program interface that predicts the sex of individuals based on their name, and the geographic distribution of women PIs was examined. Results: From 2007 to 2022, women PIs increased from zero to 26.86%. The United States saw no significant increase (β = 1.553; P = 0.125), but international trials did (β = 2.845; P = 0.008). Women PIs led more active/completed trials and trials with behavioral/other interventions. Geographic analysis showed higher representation in North America (38.47%), especially the Northeast (28.17%) and West (25.35%). The United States had 28.74% women PIs, with California (15.49%) leading. Conclusion: Progress toward gender parity in pediatric orthopaedic research is evident; however, disparities still exist. Efforts to provide additional research opportunities for women in orthopaedics may be crucial in attracting and retaining diverse talent in the field. Targeted initiatives may have potential in achieving equal representation in orthopaedics.