Representation of Hispanic patients in renal cell carcinoma clinical trials: A scoping review (2005–2025)

Background: Hispanic adults comprise approximately 19.1% (63.6 million) of the U.S. population yet remain yet only 2%–4% of therapeutic oncology trial participants are Hispanic/Latinx. Renal cell carcinoma (RCC) is one of the most rapidly increasing cancers in this group, accounting for nearly 8000 new cases and over 1300 deaths annually among Hispanic Americans. Despite this burden, the inclusion, reporting, and analysis of Hispanic participants in RCC drug trials have not been systematically evaluated. Objective: To assess Hispanic inclusion, demographic reporting, and subgroup analysis in Phase III and IV systemic therapy trials for RCC conducted between 2005 and 2025. Methods: A scoping review was conducted following the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. Systematic searches were performed using PubMed, Embase, and ClinicalTrials.gov for trials registered or published between January 1, 2005, and January 1, 2025. The search strategy combined terms for RCC, clinical trial phase (III and IV), Hispanic or Latino identity, and human subjects. Trials were eligible if they evaluated systemic therapies for RCC and enrolled at least 50 adult participants. Trials were excluded if they were Phase I or II, observational, lacked accessible results, or omitted any demographic reporting. Data extracted from each trial included total sample size, percentage of Hispanic participants (if reported), presence or absence of a Hispanic ethnicity option, and whether subgroup analyses by ethnicity were performed. Results: After removing duplicates, and studies that did not meet inclusion criteria, 31 trials involving 20,550 participants met inclusion criteria. Only eight trials (25.8%) reported Hispanic participant percentages, which ranged from 0% to 12.9% (mean 4.95%), significantly below their national population share. Six trials (19.4%) collected demographic data but did not list Hispanic/Latino as an ethnicity category. 17 trials (54.8%) failed to report any race or ethnicity data. None conducted Hispanic-specific subgroup efficacy or toxicity analyses. Conclusion: Although Hispanic individuals represent nearly one-fifth of the U.S. population and face a growing RCC burden, they are notably underrepresented or omitted in RCC systemic phase III and IV therapy trials of the last 20 years. Many trials neglect ethnicity data collection or structurally exclude Hispanic identity, and none perform ethnicity-stratified analyses. To foster equitable and generalizable oncologic research, future RCC trials must standardize ethnicity reporting, proactively recruit Hispanic participants, and incorporate race- and ethnicity-stratified outcome analyses.