Black patients are better represented in taxpayer-funded cancer clinical trials compared to trials run by pharmaceutical companies, although they remain underrepresented in clinical trials, regardless of sponsor. These results were published by Joseph M. Unger, PhD, and colleagues in JNCI Cancer Spectrum, and were presented as a poster during the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting II (Abstract 4344).
Joseph M. Unger, PhD
The study was conducted by SWOG Cancer Research Network, a member of the National Cancer Institute’s (NCI) National Clinical Trials Network (NCTN), the oldest and largest publicly funded cancer trial network in the United States. For more than 60 years, SWOG and other NCTN groups have run thousands of trials that enroll about 20,000 patients each year.
The NCTN comprises more than 2,200 cancer centers, academic medical centers, and community hospitals across the United States and around the world. A companion network, the NCI Community Oncology Research Program (NCORP), runs prevention and cancer care delivery trials and encompasses community and rural hospitals in its network, including sites with significant minority and underserved patient populations. About 25% of all NCORP trial volunteers are racial and ethnic minorities.
Dr. Unger, a SWOG biostatistician and health services researcher at Fred Hutchinson Cancer Research Center, specializes in cancer disparities research with a focus on the impacts of insurance status, race and ethnicity, and income on health outcomes. For this study, Dr. Unger and colleagues compared black patient enrollment in NCI-sponsored trials and industry-sponsored trials.
“It’s a critical question,” said Dr. Unger. “Trials are an important way—sometimes the only way—for patients [with cancer] to receive potentially breakthrough drugs. Everyone can get cancer, so everyone should have the same access to investigational cancer treatments. In addition, it’s very important from a scientific standpoint to evaluate new treatments in patients who reflect the demographics of the general cancer population.”
To conduct the study, researchers used three databases. One was the SWOG trials database, used as a proxy to estimate the rate of participation among NCI trials. In addition, the team created a database of pharmaceutical-sponsored trials that supported new drug applications and included data on trial participation by race. Finally, the team used data from the NCI’s Surveillance, Epidemiology, and End Results program, as well as data compiled by the U.S. Census Bureau, to estimate the expected rate of black patient participation in the cancers they studied.
The team analyzed data from a total of 358 trials—85 industry trials and 273 SWOG trials—that enrolled 93,825 patients being treated for 15 different cancer types. Enrollments spanned from 2003 to 2018.
In the 15 cancer types studied, the rate of black patient enrollment in industry trials was 3%, compared to 9% in SWOG trials and 12% in the corresponding U.S. cancer population, according to the team’s estimates. 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.
“This study confirmed that black patients [with cancer] are severely underrepresented in pharmaceutical company–sponsored trials, with fewer than one in four of the expected number enrolled,” said Dr. Unger. “Black representation in industry trials was also far below that of NCTN trials, with only one black patient enrolled for every three enrolled in NCTN trials.”
These results can inform policy. The U.S. Food and Drug Administration (FDA), in partnership with AACR, is examining ways to improve representation of black patients in FDA registration trials.
“NCI-sponsored trials have a broader mandate,” concluded Dr. Unger. “They reach beyond just the major cancer centers to serve patients in a more diverse community-based clinical setting. This could serve as a model for pharma trials aiming to increase representativeness of all patients.”
Disclosure: The study was funded by the National Institutes of Health, and in part by The Hope Foundation for Cancer Research and the Michael Smith Health Professional Investigator program. For full disclosures of the study authors, visit academic.oup.com or abstractsonline.com.