Women Are Underrepresented Among Principal Investigators of Hip and Knee Arthroplasty Clinical Trials in the United States

Abstract

Background: Leadership of clinical trials confers national recognition and promotes academic advancement. We hypothesized that women would be underrepresented among principal investigators (PIs) of hip and knee arthroplasty clinical trials in the United States.

Methods: A query of hip and knee arthroplasty clinical trials from 2015 to 2021 was performed on ClinicalTrials.gov. Clinical trials were included if they involved a U.S.-based orthopaedic-surgeon PI. We analyzed the sex representation of arthroplasty PIs among junior-level (assistant professor) and senior-level (associate or full professor) faculty. Participation-to-prevalence ratios (PPRs) were calculated by comparing the sex representation among arthroplasty PIs with that among academic arthroplasty faculty at institutions conducting hip and knee arthroplasty clinical trials. A PPR of <0.8 indicated underrepresentation and a PPR of >1.2 indicated overrepresentation.

Results: A total of 157 clinical trials involving 192 arthroplasty PIs were included. Of these PIs, only 2 (1.0%) were women. PIs were mostly funded by academic institutions (66%) and industry (33%). U.S. federal sources funded a minority (1%) of PIs. Of the 243 male arthroplasty faculty who were eligible, 190 men (78.2%) served as PIs. In contrast, of the 17 female arthroplasty faculty who were eligible, only 2 women (11.8%) served as PIs (p < 0.001). Across the entire cohort of arthroplasty PIs, women were underrepresented (PPR = 0.16), whereas men were equitably represented (PPR = 1.06). Women were underrepresented at the assistant professor (PPR = 0.0), associate professor (PPR = 0.52), and full professor (PPR = 0.58) levels.

Conclusions: Women were underrepresented among PIs of hip and knee arthroplasty clinical trials, which may lead to disparities in academic promotion and advancement. More research is needed to understand the potential barriers to female leadership of clinical trials. Greater awareness and engagement are needed to create sex equity in clinical trial leadership for hip and knee arthroplasty research.

Clinical relevance: The underrepresentation of women among arthroplasty PIs may lead to fewer options in surgical providers for patients and may limit access to musculoskeletal care for certain patient populations. A diverse arthroplasty workforce can promote attention to issues that disproportionately affect historically underrepresented and vulnerable patient populations.