Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals

Jonathan M. Loree, MD

In a study reported in JAMA Oncology,¹Jonathan M. Loree, MD, of BC Cancer, Vancouver, British Columbia, Canada, and colleagues found that race and race subgroup analyses were frequently not included in reported trials supporting U.S. Food and Drug Administration (FDA) oncology drug approvals between 2008 and 2018. Furthermore, black and Hispanic patients were underrepresented in these trials.

The study included data from all reported trials supporting oncology drug approvals between July 2008 and June 2018, with primary reports of the trials being obtained from PubMed and ClinicalTrials.gov. U.S. population–based cancer estimates by race/ethnicity were derived from National Cancer Institute–Surveillance, Epidemiology, and End Results and U.S. Census databases.

Key Findings

Among 230 trials with a total of 112,293 participants, 145 trials (63.0%) reported on one or more races as a baseline characteristic, 85 (36.9%) included no mention of race, and 18 (7.8%) reported data on patients of all four major races—white, Asian, black, and Hispanic. Reporting on white, Asian, black, and Hispanic races was included in 144 (62.6%), 110 (47.8%), 88 (38.2%), and 23 (10.0%) trials, respectively.

Overall, 58 trials (25%) included race subgroup analyses, accounting for 40% of the 145 trials that reported on race. Among all trials, a subgroup result for white, Asian, black, and Hispanic patients was reported in 49 (21.3%), 32 (13.9%), 5 (2.2%), and 1 (0.4%) trials.

For July 2008 to June 2013 vs July 2013 to June 2018, 56.6% (45 trials) vs 67.1% (100 trials) of trials reported race (odds ratio = 1.63, P = .09) and 16.1% (13 trials) vs 30.2% (45 trials) reported one or more race subgroup analyses (odds ratio = 2.26, P = .03).

Overall, white, Asian, black, and Hispanic patients represented 76.3%, 18.3%, 3.1%, and 6.1% of trial participants, respectively. From July 2008 to June 2013 vs July 2013 to June 2018, the proportions were 3.6% vs 2.9% for black patients and 5.3% vs 6.7% for Hispanic patients.

Compared with the estimated proportion of U.S. cancer incidence, trial participation was 22% of expected for black patients, 44% of expected for Hispanic patients, 98% of expected for white patients, and 438% of expected for Asian patients.

The investigators concluded, “Race and race subgroup analysis reporting occurs infrequently, and black and Hispanic races are consistently underrepresented compared with their burden of cancer incidence in landmark trials that led to FDA oncology drug approvals. Enhanced minority engagement is needed in trials to ensure the validity of results and reliable benefits to all.” ■

DISCLOSURE: For full disclosures of the study authors, visit jamanetwork.com.

REFERENCE

1. Loree JM, Anand S, Dasari A, et al: Disparity of race reporting and representation in clinical trials leading to cancer drug approvals from 2008 to 2018. JAMA Oncol. August 15, 2019 (early release online).