Race reporting and representation in clinical trials from 2007-2020: An analysis of gynecologic oncology and other gynecology specialties (556).

Objectives: To characterize race and ethnicity reporting and representation in United States (US) gynecologic oncology (Gyn-Onc) clinical trials and compare reporting and representation across gynecology subspecialties. Methods: In this cross-sectional study, we investigated all US-based gynecology clinical trials that reported results on ClinicalTrials.gov from October 2007-March 2020, with a focus on Gyn-Onc. We evaluated two outcomes: (1) reporting of participant race/ethnicity and (2) representation (proportion of trial enrollees of a given race/eth- nicity). We analyzed associations of trial funding and subspecialty with each outcome using descriptive and multivariable logistic regression analyses. We modeled representation using logistic regression with a binary outcome (> or <20% Black, Indigenous, and People of Color [BIPOC] enrollment) controlling for a trial year, phase, and funder. [Display omitted] Results: Of 8,515 registered gynecology trials, 3,214 were based in the US. Only 888 of 3,214 (27.6%) reported trial results, of which 505 (56.9%; 190,147 participants) included participant race/ethnicity data. There was a significant increase in race/ethnicity reporting over the study period (p<0.001). Race/ethnicity reporting varied by funder (government/academic 14.2%, industry 19.4%, p<0.001) and subspecialty (Gyn-Onc 13.9%, Benign Gynecology 16.6%, p=0.002), but these reporting differences were not persistent in multivariable analysis. Among trials that reported race/ethnicity, all BIPOC groups were underrepresented relative to their national population representation (Table). No significant difference in representation was seen by funding status. However, differences by subspecialty were noted; in aggregate, Benign Gynecology trials had more than twice as much diversity as Gyn-Onc trials (39.6% vs 17.7% average BIPOC representation per trial). Compared with Gyn-Onc clinical trials, REI (aOR: 2.78, 95% CI: 1.36-6.47), family planning (aOR: 3.68, 95% CI 1.87-8.16), and other benign gynecology trials (aOR: 1.79, 95% CI: 1.26-2.55) all had greater odds of enrolling at least 20% BIPOC participants. No difference was demonstrated between Gyn-Onc and Urogynecology trials. Conclusions: Reporting of race/ethnicity in US gynecology clinical trials is poor but improving. Among trials with race-ethnicity reporting, BIPOC participants were consistently underrepresented. Gyn-Onc trials demonstrated the least diversity of all gynecology subspecialties. This trend excludes BIPOC communities from health innovation conferred through trial participation, biases medical evidence, and worsens disparities in gynecology. [ABSTRACT FROM AUTHOR]