Racial representativeness of cancer clinical trials sponsored by the National Cancer Institute compared to pharmaceutical companies
Joseph M Unger1, Dawn L Hershman2, Raymond U Osarogiagbon3, Anirudh Gothwal4, Seerat Anand5, Arvind Dasari5, Michael Overnman5, Jonathan M Loree6, Kanwal Raghav5
1Fred Hutchinson Cancer Research Center, Seattle, WA, United States
2Columbia University, New York, NY, United States
3Baptist Cancer Center, Memphis, TN, United States
4Baylor University, Houston, TX, United States
5The University of Texas MD Anderson Cancer Center, Houston, TX, United States
6BC Cancer, Vancouver, BC, Canada
Purpose Many clinical trials supporting new drug applications underrepresent minority patients. Trials conducted by the NCI’s clinical trial network (NCTN) have greater outreach to community sites, potentially allowing better representation. We compared the representation of black patients in pharmaceutical company-sponsored cancer clinical trials to NCTN trials and the U.S. cancer population.

Procedures We established a large cohort of study publications representing the results of pharmaceutical-company sponsored trials that supported new U.S. Food and Drug Administration (FDA) drug approvals from 2008-2018. NCTN trial data were from the SWOG Cancer Research Network. U.S. cancer population rates were estimated using Surveillance, Epidemiology, and End Results (SEER) survey data. We compared the proportion of black patients by enrollment year for each cancer type and overall. Comparisons between groups were conducted using tests of proportions.

Results 227 trials (pharmaceutical company-sponsored trials, 74; SWOG trials, 153) comprised of 79,592 patients (pharmaceutical company-sponsored trials, 43,567; SWOG trials, 36,025) for nine specific cancer types were analyzed. Overall, the proportion of black patients was 2.9% for pharmaceutical company-sponsored trials, 8.3% for SWOG trials, and 12.1% for the U.S. cancer population (p<.001 for each pairwise comparison). For each cancer type, the proportion of black patients was statistically significantly lower for pharmaceutical company-sponsored trials compared to SWOG trials (except for melanoma) and compared to the U.S. cancer population.

Conclusions The poor representation of minority groups in pharmaceutical company-sponsored trials is of vital scientific concern. These trials could support the use of new drugs with little data about efficacy or side effects in key populations. Because pharmaceutical company-sponsored trials test the newest available therapies, limited access to these trials represents a disparity in access to potential breakthrough therapies. Pharmaceutical companies could improve racial/ethnic diversity in their trials - and expand access to all patients - through increased outreach to community sites, as suggested by the findings for the NCTN trials. These results have the potential to directly influence policy, as the FDA, in partnership with the American Association for Cancer Research, is currently examining ways to improve representation of black patients in FDA registration trials.

Session: Science and Health Policy (Virtual Poster Session)