Many trials in the last decade that have led to FDA drug approvals didn't report on race and the ones that did were lacking in racial diversity.
During the last decade, more than one-third of trials that led to US Food and Drug Administration (FDA) oncology drug approvals did not include reporting on race, according to the results of a recent study in JAMA Oncology.
Of the 230 trials with more than 110,000 participants supporting FDA oncology drug approvals from 2008 and 2018, only 63.0% reported on at least one race, 7.8% reported on all four major races in the United States (white, Asian, black, and Hispanic), and 25.2% reported race subgroup analyses. Of the about two-thirds that reported on one race, the race was white in 62.6%, Asian in 47.8%, black in 38.2%, and Hispanic in 10.0% of trials.
“With efforts such as the Affordable Care Act attempting to improve access to standards of care, we demonstrate a pressing need to improve representation in cancer research,” wrote Jonathan M. Loree, MD, of BC Cancer, Vancouver, British Columbia, and colleagues.
Between July 2008 and June 2013 compared with July 2013 and June 2018, the number of trials reporting race (odds ratio=1.63; 95% CI, 0.93–2.87; P=.09) and race subgroup analysis (OR=2.26; 95% CI, 1.16–4.67; P=.03) changed minimally and varied across races.
According to the study, the FDA “recommends accurate collection and reporting of race/ethnicity and expects sponsors to enroll patients who reflect relevant populations”. Despite this, there is little established to enforce these recommendations, and certain races remain underrepresented in clinical trials. In the included trials, white patients represented 76.3% of trials participants (98% of expected). Asian patients represented 18.3% of trial participants (438% of expected). In contrast, black patients represented 3.1% of participants (22% of expected) and Hispanic patients represented 6.1% of participants (44% of expected).
These results were consistent across all cancer types, with consistent underrepresentation of black and Hispanics.
In addition, the National Institutes of Health guidelines mandate “proportional racial representation in NIH-funded clinical research; however, because most trials that lead to drug approvals are funded by industry, broader reaching efforts are needed,” the researchers wrote.
Commenting on the study, Camille Ragin, PhD, MPH, of Fox Chase Cancer Center in Philadelphia, told Cancer Network that low participation rates among minority racial/ethnic groups in research is a major issue that is forefront in the minds of many cancer disparities researchers, and this publication provides further confirmation.
“Lack of diversity inclusion in clinical trials may further perpetuate cancer disparities since new discoveries will only benefit those that are well represented in these studies,” Ragin said. “All scientists, whether focused on cancer disparities research or not, should become more aware of this and should always make every effort to address this concern.”