Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018

Abstract

IMPORTANCE Representative racial/ethnic participation in research, especially in clinical trials that establish standards of care, is necessary to minimize disparities in outcomes and to uphold societal equity in health care. OBJECTIVE To evaluate the frequency of race reporting and proportional race representation in trials supporting US Food and Drug Administration (FDA) oncology drug approvals. DESIGN, SETTING, AND PARTICIPANTS Database study of all reported trials supporting FDA oncology drug approvals granted between July 2008 and June 2018. Primary reports of trials were obtained from PubMed and ClinicalTrials.gov. Food and Drug Administration approvals were identified using the FDA archives. The US population-based cancer estimates by race were calculated using National Cancer Institute-Surveillance, Epidemiology, and End Results and US Census databases.MAIN OUTCOMES AND MEASURES Primary outcomes were the proportion of trials reporting race and the proportion of patients by race participating in trials. Secondary outcomes included race subgroup analyses reporting and gaps between race proportion in trials and the US population. Descriptive statistics, Fisher exact, and χ 2 tests were used to analyze the data. Proportions and odds ratios (OR) with 95% CIs were reported.RESULTS Among 230 trials with a total of 112 293 participants, 145 (63.0%) reported on at least 1 race, 18 (7.8%) documented the 4 major races in the United States (white, Asian, black, and Hispanic), and 58 (25.2%) reported race subgroup analyses. 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.

Racial and Ethnic Disparities Among Participants in US-Based Phase 3 Randomized Cancer Clinical Trials

“…Nonetheless, to our knowledge, this analysis represents the index aggregate utilization of federal public access datasets to assess domestic disparities in racial and ethnic phase 3 clinical trial enrollment. Although others have investigated Food and Drug Administration–approval trials ( 13 ), our use of US-limited, large-scale public access datasets affords a benchmark for future serial assessments and US policy decisions.…”

NCI–Clinical Trial Accrual in a Community Network Affiliated with a Designated Cancer Center

“…Our analysis did reveal a higher accrual of African American patients to non-therapeutic trials at the community sites compared to main campus but did not significantly improve diversity of trial accrual as had been hoped. Loree et al [ 9 ] had reported African Americans and Hispanics representing 3.1% and 6.1% of trial participants respectively, and City of Hope’s rate of African American representation in trial accrual was similarly low. A limitation of our analysis is that our percentages are derived from accrued subjects rather than all subjects; that is to say, the denominator are trial participants, rather than all screened patients or all eligible patients or all patients seen at the clinic, as such data was not available for analysis.…”

Sex Representation in Clinical Trials Associated with FDA Cancer Drug Approvals Differs Between Solid and Hematologic Malignancies

“…Baseline approval and trial characteristics have been reported previously [25]. Of 228 reported trials leading to 204 FDA cancer drug approvals involving 108 different drugs between July 2008 and June 2018, there were 222 trials involving 109,987 patients in which information on sex of participants was available (Table 1).…”