Introduction: To assess reporting and representation of race and ethnicity in United States (US) based clinical trials focused on urology. Methods: We performed a cross-sectional study of US based trials (2007-2020) with results reported to the ClinicalTrials.gov registry. We examined whether race and ethnicity data were reported, evaluated changes over time with Mann-Kendall trend test, and compared race and ethnicity representation (proportion of enrolled participants reported as White, Black, Hispanic, Asian, or Native American) within trial funding sponsor (Industry, US Government, Academic) and urologic subspecialty (Oncology, Andrology, Endourology, Female, General Urology, Pediatrics, Renal Transplant). Results: Of 9,015 urologic trials, 39.7% (3,583) were US-based of which 837 (23.4%) reported results to the registry. 417 (49.8%) reported any race and ethnicity data, involving 37,465 participants. Reporting increased over time (Fig1, p<0.001). Reporting was significantly associated with sponsor (p < 0.001, US Government outperforming Industry and Academic) and subspecialty (p=0.02, highest with Oncology and lowest with Endourology and General Urology) (Table). Racial and ethnic minorities (15.0%) were underrepresented relative to US Census data (27.6%), most notable with Hispanic patients (3.6% vs 15.4%, respectively). Trial diversity was significantly associated with subspecialty (p < 0.001) but not sponsor (p=0.18). Oncology (13.3%) and Female (12.7%) had the least trial diversity while Pediatrics (30.6%) and Renal Transplant (41.0%) were the most diverse. Conclusions: Inadequate reporting of race and ethnicity data in clinical trials impedes understanding of barriers to trial diversity. Reported data demonstrates urologic clinical trials are not representative of the US population. This lack of representation perpetuates health disparities, with serious repercussions for underrepresented groups and for the field as a whole. Urology as a field should strive to improve diversity in clinical trial enrollment. SOURCE OF Funding: None
