Adequate racial and ethnic representation in cancer clinical trial enrollment: Real-world evidence from an NCI-designated cancer center in a minority-majority county.

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Background: Despite strides to increase diversity in clinical trial enrollment, significant racial and ethnic disparities persist. This limits the generalizability of clinical trial data and consequently the application of novel therapeutics for diverse populations. We hypothesized that enrollment of underrepresented minorities (URM) is feasible, with improved access to clinical care and a tailored clinical trial portfolio addressing the unmet needs in URM. Methods: A retrospective cohort study was conducted at the University of California Irvine Chao Comprehensive Cancer Center (CFCCC), an NCI-Designated cancer center located in Orange County (OC), CA (a minority-majority county). Clinical trial enrollment data from 2015-2023 through the CFCCC clinical research database was included. Collected data on patient demographics, tumor types, and trial enrollment was compared to data provided by the NIH SEER reports in both OC and United States. Results: Between 2015-2023, 2317 subjects were enrolled in clinical trials at CFCC. Demographics were as follows: White, Asian, Black, American Indian/Alaska Native, mixed/unknown race (66.4%/20.1%/2.4%/0.7%/0.7%/9.3%). Non-Hispanic vs Hispanic ethnicity (77.8%/20.5%). Female vs Male sex (47.6%/52.3%). Age <70 vs >70 years (73.3%/26.7%). Study Phase: Phase I/II (35.6%), Phase II (25.4%), Phase II/III (2.8%), Phase III (26.6%), and Phase IV (0.3%). Study sponsor: Industry (61.1%), Institutional (23.6%), National (14.8%), and Externally Peer Reviewed (0.3%). Most notably, the Asian enrollment (20.1%) and Hispanic enrollment (20.6%) exceeded demographic representation of Asians (17%, RR 1.18) and Hispanics (19%, RR 1.07) at CFCCC. Lastly, Asian patients enrolled at significantly higher rates in lung and liver cancer trials, while Hispanic patients and Black patients enrolled at higher rates in breast cancer and prostate cancer trials respectively. Conclusions: Our results demonstrate that robust URM clinical trial enrollment, particularly among Asian and Hispanic populations, is feasible at an NCI-designated cancer center despite minority-specific barriers. These findings suggest that minority populations can be optimally enrolled in clinical trials when these trials are accessible and tailored to the population at hand. Further research is necessary to investigate factors that influence clinical trial participation in the pursuit of equitable cancer care.