Ethnic and racial minority patients are under-represented in US clinical trials for surgical management of hip fractures

Abstract

Introduction

The impact of social determinants on clinical outcomes following surgeries for orthopaedic injuries are well-documented. In this study, we sought to quantify the representation of women, racial, and ethnic minorities in US-based clinical trials for hip fracture surgery.

Methods

This was a cross-sectional analysis of patients enrolled in US-based, interventional clinical trials for hip fractures registered on ClinicalTrials.gov (2000–2022). Participation-to-prevalence ratios (PPRs) were calculated for demographic groups in clinical trials relative to their prevalence among patients receiving hip fracture surgery in the National Inpatient Sample (2006–2015). PPRs between 0.8–1.2 were considered equitable representation. PPRs<0.8 were considered underrepresentation and PPRs>1.2 were considered overrepresentation. Temporal trends were analyzed between previous (2000–2010) and contemporary (2011–2022) periods.

Results

There were thirty-eight hip fracture clinical trials involving 6937 participants included in this study. All clinical trials reported sex, but only sixteen trials (42 %) reported race and ten trials (26 %) reported ethnicity. In total, trial participants were predominately White (89.3 %) and female (68.0 %). Few patients were non-White including Asian (7.2 %), Black (2.1 %), and Hispanic (0.8 %). Female (PPR=0.97) and male (PPR=1.07) patients had equitable representation. However, Hispanic (PPR=0.22), and African American (PPR=0.51) patients were underrepresented. White patients (PPR=1.00) had equitable representation while Asian patients were overrepresented (PPR=4.50). The rate of race (P < 0.001) and ethnicity (P = 0.010) reporting increased between previous and contemporary periods.

Conclusion

Recruitment of racial and ethnic minorities into hip fracture clinical trials remains limited. The impact of social determinants on outcomes after trauma surgery requires equitable representation of all groups in clinical trials to ensure translatability of results. Stakeholders across healthcare, industry, and government must work to address these disparities.