More than one-third of clinical trials that led to the approval of new cancer drugs between 2008 and 2018 did not include data on participants' race, according to a new study published in JAMA Oncology.
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FDA recommends that researchers report on the race and ethnicity of its participants for clinical trials supporting drug approvals, but research reveals the recommendation alone is not enough to yield appropriately diverse patient populations in clinical trials.
For the study, the researchers evaluated how often researchers in clinical trials for FDA-approved oncology drugs reported race and how representative clinical trials are of U.S. race demographics. The researchers reviewed 230 clinical trials supporting FDA-approved oncology drugs with a total of 112,293 participants between July 2008 and June 2018. The researchers calculated U.S. population-based cancer estimates using data from the National Cancer Institute's Surveillance, Epidemiology, and End Results Program and U.S. Census.
Race not reported in many oncology clinical trials, study finds
The analysis found that 63% of the trials reported on at least one race of its participants while only about 8% broke down data by the four major U.S. racial groups, which include white, Asian, black, and Hispanic. Of the trials that reported at least one race, 25% reported race subgroup analyses.
Among the trials that did report on race, there were fewer black and Hispanic participants than would be expected based on the racial makeup of the patient population, according to the researchers.
For instance, white patients made up 76% of trial participants overall and Asian patients made up 18%, but Hispanic and black patients accounted for 6% and 3% of participants, respectively.
When the researchers compared participants against their expected share of the U.S. cancer incidence, they found black patients were reported at 22% of their expected representation and Hispanics were reported at 44% of their expected representation. White patients and Asian patients were reported at 98% and 438% of their expected representation, respectively.
The researchers found that the proportion of black and Hispanic patients in the trials did increase slightly between 2008 and 2018.
The study also revealed that participants' race played a part in the type of trials they enrolled in. For example, white patients were more likely to enroll in big, randomized, late-stage trials with multiple arms, while minority racial groups were more likely to enter small, non-randomized trials with one arm.
The researchers said it's crucial for race to be reported and considered for drug trials that play a key role in oncology care.
"When you come across clinical trials that establish FDA approval or standard of care [for a new drug], they should definitely be representative of the population it's used to treat," according to Kanwal Raghav, an oncologist at MD Anderson Cancer Center and an author of the study. "It's important to recognize that this problem is there and this problem is persisting over the years."
Raghav said the findings may encourage researchers to be more critical about how they recruit and run their clinical trials. "You do a trial of cancer patients across the country, you should see that kind of proportional representation. If it's not being done, why is it not," Raghav said.
Further, Raghav noted, "The issue here is not where the funds are coming from. The issue here is doing the right thing" (Thielking, STAT News, 8/19; Loree et al., JAMA Oncology, 8/15).