Ethnic disparities in clinical trials for FDA-approved drugs in urothelial cancer: An analysis in the post-COVID-19 era (2020-2024).

677 Background: Ethnic and racial disparities in oncology clinical trial participation continue to pose significant challenges. Despite initiatives by the NCI and FDA to address these disparities through policies established in 2017, notable gaps in both cancer treatment and clinical trial involvement persist. There is a lack of comprehensive data regarding minority participation in clinical trials for FDA-approved urothelial cancer therapies in the post-COVID-19 context. Methods: From 2020 to 2024, we examined data from 2,755 patients recruited in eight industry-sponsored clinical trials (BCL2001, CheckMate 274, CheckMate 901, EV-302, KEYNOTE 057, CS-003, QUILT-3.032, TROPHY) that led to the FDA approval of new agents or indications for urothelial cancer. We assessed and tabulated the reporting of racial demographics within these trials, employing chi-square statistics and machine learning algorithms to compare participation among White, Black, Asia and Hispanic patients against SEER data on urothelial cancer incidence. Results: Race data was reported in 7 (BCL2001, CheckMate 274, CheckMate 901, EV-302, CS-003, QUILT-3.032, TROPHY) out of 8 trials (87.5%), but only 5 (CheckMate 274, CheckMate 901, EV-302, CS-003, TROPHY) of these trials (71%) included data on Black and Asian populations alongside White participants. Notably, none of the trials reported date on Hispanic participants. Our analysis revealed that in the 7 trials providing race data, 79% of participants were White, indicating overrepresentation (p=0.013). among the 5 trials with comprehensive race reporting, Blacks were unrepresented at 2.3% (p=0.001), while Asians constituted 10%, showing no statistical significance (p=0.90) in difference in representation. No data was available for Hispanics. Conclusions: The continued underrepresentation of minorities in FDA-approved clinical trials for urothelial cancer is a pressing concern still in the post-COVID-19-era. To rectify these issues, it is essential to implement policies that improve data collection and standardize ethnic nomenclature. Furthermore, international collaborative trials should prioritize separate data reporting for U.S. participants, utilizing NCI SEER nomenclature to endure accurate representation and analysis.