Over the last decade, clinical trials that have served as the basis for the U.S. Food and Drug Administration’s (FDA’s) approval of oncology drugs consistently underrepresented black and Hispanic populations and infrequently reported race, according to results from a study published in JAMA Oncology.
Jonathan M. Loree, MD, and colleagues from the University of British Columbia, along with researchers from MD Anderson Cancer Center, Fred Hutchinson Cancer Center, and Baylor University, investigated race representation and reporting in pivotal trials of anti-cancer drugs between July 2008 and June 2018.
The researchers found that, of 230 trials with a total of 112,293 participants, 63% reported on at least one race, while just 7.8% reported on the four major races (white, Asian, black, and Hispanic) in the U.S. One-quarter (25.2%) included at least one subgroup analysis by race. Of those trials where participants’ race was documented, more than three-quarters of patients were white (76.3%), while 18.3% reported Asian race, 3.1% reported black race, and 6.1% reported Hispanic race.
These results demonstrate that minority populations are underrepresented in trials, relative to the burden of cancer incidence in the U.S. “Our findings show that the science might not be applicable to the population that’s going to receive the medications,” Dr. Loree said. “If patients are going to be receiving this drug, we need to know that it’s going to work for them with the same effectiveness that’s seen in the trial.”