767 Racial and Gender Disparities in Traumatic Brain Injury Clinical Trial Enrollment

INTRODUCTION: Despite the increasing number of women and racial/ethnic minorities sustaining Traumatic Brain Injuries (TBI), they are underrepresented in TBI clinical trials. METHODS: The authors conducted a review of TBI clinical trials with reported results registered in ClinicalTrials.gov between 2008 and 2022. The studies were assessed for the proportion of women and racial/ethnic minorities enrolled as well as their reporting of race and gender-specific characteristics such as Gender Ratio (GR) and Racial Diversity Index (RDI). Furthermore, study parameters including year and duration, phase, trial design, type of funding, and trial completion were included. RESULTS: 135 clinical trials met inclusion criteria, of which 65 and 134 reported race and gender, respectively. 25 trials were found to have existing racial disparity (RDI < 1). Comparatively, industry-funded trials had a 26% more likelihood of racial disparities (p = 0.026), whereas federally-funded trials were 30% less likely (p = 0.031). 66 trials had gender disparities (GR < 0.4) present, with federally-funded trials having 37.1% greater rates of gender disparity (p < 0.001, aOR: 5.47, 95% CI: 2.26-14.25). The impact of funding source on race and gender remained significant despite adjusting for other covariates in the multivariate analyses. Racial disparity was negatively correlated with trial completion rate (p < 0.001). Disparities were not found to improve over the 14-year span. CONCLUSIONS: Racial and gender disparities in TBI clinical trial enrollment persist, and the lack of diversity may lead to biased evidence-based medicine. Efforts should be made to increase the representation of women and racial/ethnic minorities in TBI clinical trials to ensure equitable access to effective treatments for all populations.