Disparity of Race Reporting in FDA Drug Approvals for Urinary System Cancers from 2006 to 2021

Background Significant racial disparity exists in urinary system cancers (urothelial carcinoma [UC] and renal cell carcinoma [RCC]), in terms of epidemiology, access to therapy and outcomes. We analyzed racial diversity and race reporting in FDA drug registration trials for UC and RCC. Method All FDA pivotal registration trials between 2006-2021 for both UC and RCC were identified. The trials were analyzed to check for compliance with current FDA recommendations for race reporting. Additional information on participant recruitment and race was obtained to assess representation based on cancer type. Results From 2006-2021 there were 30 new drug registrations for the management of urinary systems cancers, of which 16 in RCC and 14 in UC. Overall, 70% of these trials reported data on racial representation, however, only 43% reported data stratified into five categories as recommended by the FDA. Conclusion We found a significant under-representation of non-white participants in FDA drug registration clinical trials in UC and RCC. Race reporting is inconsistent and FDA guidelines are not being universally followed. Considering the disproportionate disease burden in UC and RCC, clinical trials should prioritize recruiting a diverse population of participants.