Black patients are better represented in taxpayer-funded clinical trials testing new cancer treatments compared to trials run by pharmaceutical companies, according to a study conducted by SWOG Cancer Research Network, a member of NCI’s National Clinical Trials Network.
The study also found that black patients are not fully represented in cancer clinical trials.
The results are published in JNCI Cancer Spectrum, and were presented as a poster in the 2020 American Association for Cancer Research virtual annual meeting II.
A companion network to NCTN, the NCI Community Oncology Research Program runs prevention and cancer care delivery trials, and includes 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. Both NCTN and NCORP trials are designed by doctors, paid for with public funds from the NIH through the NCI, and powered by patient volunteers.
The study compared black enrollment in NCI-sponsored trials and industry-sponsored trials.
“Everyone can get cancer, so everyone should have the same access to investigational cancer treatments,” Joseph Unger, a SWOG biostatistician and health services researcher based at Fred Hutchinson Cancer Research Center, who specializes in cancer disparities research with a focus on the impacts of insurance status, race and ethnicity, and income on health outcomes, said in a statement. “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, Unger and his team used three databases. One was the SWOG trials database, used as a proxy to estimate the rate of participation among NCI trials. Unger’s colleagues, led by Kanwal P.S. Raghav, of MD Anderson Cancer Center and Jonathan M. Loree, of BC Cancer, created a database of pharmaceutical company-sponsored trials that supported new drug applications and included data on trial participation by race.
The team also 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 participation in the cancers they studied.
Unger and his 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 the years 2003-2018. In those 15 cancers, the rate of black enrollment in industry trials was 3% compared to 9% in SWOG trials, and 12% in the corresponding U.S. cancer population/.
“This study confirmed that black cancer patients are severely underrepresented in pharmaceutical company sponsored trials, with fewer than one in four of the expected number enrolled,” Unger said. “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.”
FDA and AACR are examining how to improve representation of black patients in FDA registration trials. Registration trials are specially designed studies conducted with the expectation that the data they produce will be used to apply to the FDA for new drug approval, or to expand the uses of a currently approved cancer drug. Unger serves on this FDA and AACR task force.
“NCI sponsored trials have a broader mandate,” Unger said. “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.”
Unger’s study was funded by the NIH through NCI grant award CA189974 and CA189873 and in part by The Hope Foundation for Cancer Research and the Michael Smith Health Professional Investigator program.
Unger’s research team included Dawn Hershman, of Columbia University; Raymond U. Osarogiagbon, of Baptist Cancer Center; Anirudh Gothwal, of Baylor University; Seerat Anand, of MD Anderson Cancer Center; Arvind Dasari, of MD Anderson Cancer Center; Michael Overman, of MD Anderson Cancer Center; Jonathan M. Loree, of BC Cancer; and Kanwal Raghav, of MD Anderson Cancer Center.
