A study shows that black cancer patients are better represented in publicly-funded clinical trials for new cancer drugs compared to trials funded by pharmaceutical companies. The findings will be presented as a poster in the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting II held June 22-24.
To conduct the study, researchers three databases. One was the SWOG trials database, used as a proxy to estimate the rate of participation among NCI trials. In addition, Unger’s colleagues – led by Kanwal P.S. Raghav, MD, of MD Anderson Cancer Center and Jonathan M. Loree, MD of BC Cancer – created a database of pharmaceutical company 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 (SEER) 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.
Subsequently, the team analyzed data from 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.
According to the results, those 15 cancers, the rate of black enrollment in industry trials was 3 percent, compared to 9 percent in SWOG trials and 12 percent in the corresponding U.S. cancer population, according to the team’s estimates.
“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,” said Joseph Unger, PhD, a SWOG biostatistician and health services researcher based at Fred Hutchinson Cancer Research Center in a press release about the study. “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, according to the researchers, can impact policy. The U.S. Food and Drug Administration, in partnership with AACR, is now examining ways 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.
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“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.”
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