Race in US obstetric clinical trials: An analysis of reporting and representation from 2007-2020

Abstract

To characterize race and ethnicity reporting and representation in United States (US) obstetric clinical trials and analyze factors associated with diverse representation. We performed a cross-sectional study of all US-based obstetric clinical trials registered on ClinicalTrials.gov between October 2007 and March 2020. Among trials with reported results, we examined the associations between funding, study focus and two outcomes of interest: reporting of race/ethnicity and representation (proportion of trial enrollees) by race/ethnicity. We also compared reporting to publications of registered trials in peer-reviewed journals. Of 4,282 registered obstetric trials, 1252 were US-based obstetric trials, of which 11.3% (N=141, including 34,215 participants) reported data on participant race/ethnicity. There was a significant increase in race/ethnicity reporting over time (p < 0.001; Figure). Racial and ethnic groups were reported at different frequencies. Race/ethnicity reporting varied by funder (government/academic 53.6%, industry 42.1%, p=0.05). Among trials that reported race/ethnicity, median Black representation was consistent with US population metrics but Latinx, Asian, and American Indian/Alaskan Native individuals were underrepresented (Table). There were no differences in representation by funder, but representation varied by trial focus. Anesthesia trials demonstrated significantly less minority representation than trials of other conditions (p=0.02). Of the 1252 trials, 195 resulted in publication. Although 81.5% reported race/ethnicity in publication, only 38.5% reported race/ethnicity on ClinicalTrials.gov. The reporting of race/ethnicity in US obstetric clinical trials is poor but improving. In contrast to published reports demonstrating consistent underrepresentation of minority individuals in clinical trials, our findings suggest underrepresentation varies by racial group. Stakeholders must commit to increased reporting and more equitable representation of Latinx, Asian, and American Indian Alaska Native communities in obstetric research.View Large Image Figure ViewerDownload Hi-res image Download (PPT)