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

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.

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.

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.

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.

BJU international. 2021 Nov 08 [Epub ahead of print]

Michael Glover, Gavin Hui, Ryan Chiang, Philip Savage, Jonathan Krell, Maximilian Julve, Petros Grivas, Mark Lythgoe, Ali Raza Khaki

Department of Medicine, Stanford University, Stanford, CA, USA., Department of Oncology, Brighton & Sussex University Hospital NHS Trust, Brighton, UK., Department of Surgery and Cancer, Hammersmith Hospital, Imperial College London, London, UK., Division of Medical Oncology, Department of Medicine, University of Washington, Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA., Division of Oncology, Department of Medicine, Stanford University, Stanford, CA, USA.

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