Introduction:

Genitourinary cancers account for 1 in 5 new cancer diagnoses in the US. Significant racial disparities exist in terms of incidence, treatment, and outcomes. Limited studies have evaluated diversity, equity, and inclusion in clinicals trials resulting in novel FDA approved drugs. Our study aim was to determine the distribution of race and ethnicity among genitourinary oncology trial participants leading to FDA approval of novel drugs. Our secondary aim was to evaluate whether the proportion of underrepresented minorities in clinical trials increased over time.

Methods:

A retrospective review of FDA Center for Drug Evaluation and Research Drug Trials Snapshot (DTS) was conducted from 2015-2020 utilizing the DTS FDA website (https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots). The DTS highlights who participated in the clinical trials that supported the FDA approval of a drug that is novel (new molecular entity or original biologic product). DTS was searched for genitourinary cancers (prostate and urothelial carcinoma), and clinical trial enrollment data was stratified by race and ethnicity. We ran a Cochran-Armitage trend test to examine changes in Black patient participation over years.

Results:

A total of 9 clinical trials were identified that led to FDA approval of 5 novel drugs for prostate cancer (Ga68 PSMA-11, relugolix, darolutamide, apalutamide, fluciclovine F18) and 4 drugs for urothelial carcinoma (erdafitinib, enfortumab vedotin-ejfv, durvalumab, atezolizumab) treatment. Trials for prostate cancer included 5,202 participants with 69.8% white, 4.0% Black, 11.0% Asian, 2.5% Hispanic, <1% American Indian/Alaska Native or Native Hawaiian/Pacific Islander, 3% other (8% race/ethnicity data missing). Trials in urothelial carcinoma included 704 participants of which 75.1% were male, 80.8% white, 2.3% Black, 8.2% Hispanic, <1% American Indian/Alaska Native or Native Hawaiian/Pacific Islander, 5% other (3.3% race/ethnicity data missing). Both cancers combined showed no difference in Black patient participation rates over years (P=0.28). For prostate cancer trials, the trend of Black patient participation declined in recent years (P=0.03) Limitations include the Other race category which included both not reported and unknown in some trials.

Conclusion:

Participants in genitourinary clinical trials leading to FDA approval of novel drugs are overwhelmingly white in spite of associations of worse outcomes in underrepresented minorities who desperately need better treatment options. Involving stakeholders who represent the needs and interests of underrepresented populations in the design and implementation of clinical trials of novel agents may be a strategy to increase diversity, equity, and inclusion among genitourinary clinical trials.

Funding: N/A