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

Abstract

452 Background: Ethnic and racial disparities in oncology clinical trial participation remain a pressing challenge. Despite initiatives by the NCI and FDA since 2017 aimed at addressing these disparities, significant gaps persist in cancer treatment access and clinical trial involvement for minority populations. Notably, data on minority participation in clinical trials for FDA-approved renal cell carcinoma treatments during the post-COVID-19 era is limited. Methods: From 2020 to 2024, we analyzed data from 2,940 patients enrolled in five clinical trials (CheckMate 9ER, CLEAR, KEYNOTE 564, LITESPARK 005, TIVO-3) that resulted in FDA approval of new agents or indications for renal cell carcinoma. All trials were industry-sponsored. We assessed and tabulated the reporting of racial demographics within these trials, employing chi-square statistics and machine learning algorithms to compared participation rates among White, Black, Asian and Hispanic patients against SEER data on renal cell carcinoma incidence. Results: Among the five trials, three (KEYNOTE 564, LITESPARK-005, and TIVO-3) reported racial data, but only two (KEYNOTE 564 and LITESPARK-005) provided information beyond White participants, including Black and Asian populations. No data on Hispanic participation was reported. Our analysis revealed that in the three trails providing racial data, 88% of participants were White indicating statically significant overrepresentation (p<0.0001). In the two trials with broader racial data, Black participation was only 1.2% signifying substantial underrepresentation (p<0.0001), while Asian representation was 11.6% with no significant disparity observed (p=0.05). Conclusions: The underrepresentation of minority groups (particularly Blacks and Hispanics) in FDA-approved clinical trials for renal cell carcinoma remains a significant concern in the post-COVID-19 landscape. Addressing these disparities necessitated the implementation of policies that enhance data collection and standardize ethnic classification. Additionally, international collaborative trials should prioritize distinct data reporting for U.S. participants, utilizing NCI SEER nomenclature for consistency.