Many clinical trials of new anti-cancer drugs do not include race data.

OOne-third of the clinical trials that led to the approval of new cancer drugs approved between 2008 and 2018 did not mention the race of participants in clinical trials – and even studies that reported this race were often much less Black and Hispanic cancer patients than expected. , given the composition of the population of cancer patients.

This is the result of a new study published by JAMA Oncology on 230 clinical trials supporting oncology drugs approved by the Food and Drug Administration. Of these studies, only 145 reported at least one race of participants in the trial. The authors of the study say their findings underscore the clear need for better information and representation in cancer clinical trials sponsored by the pharmaceutical industry.

"It's important to recognize that this problem exists and persists over the years," said Dr. Kanwal Raghav, MD oncologist at the MD Anderson Cancer Center and author of the study.

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For trials that reported race, there were notable disparities in participant composition. White patients accounted for 76% of study participants, while Asian patients accounted for 18%. But black patients accounted for only 3% of clinical trial participants for cancer drugs approved during this period, and Hispanic patients accounted for only 6%. The proportion of Black and Hispanic patients participating in cancer trials has improved somewhat over the past decade, but not significantly.

Black and Hispanic patients, in particular, were underrepresented in trials leading to the approval of anti-cancer drugs. There were significantly fewer black and Hispanic patients in cancer clinical trials than expected, given the proportion of black or Hispanic cancer patients. Raghav and colleagues say this is problematic, especially for trials that play a central role in patient care.

"When you encounter clinical trials that establish an FDA approval or standard of care [for a new drug]they should certainly be representative of the population he was treating, "Raghav said.

Another striking finding: different racial groups were more likely to participate in different types of trials. White patients were more likely to participate in larger, randomized, advanced trials with multiple arms. Minority groups, on the other hand, were more likely to participate in smaller, non-randomized trials with one arm. We do not know exactly why, that's the case. But, taken together, Raghav said the findings raise questions about what disparities might suggest about how researchers recruit and conduct clinical trials.

"You are doing a clinical trial on cancer patients across the country, you should see this kind of proportional representation. If it's not done, why is not it? He asked.

The National Institutes of Health require studies that fund racial representation proportional to the patient population. But most of the human trials that contribute to drug registration are funded by the drug industry. The Food and Drug Administration recommends that trial researchers collect and report race and ethnicity data from participants, and that study sponsors should recruit patients that reflect patient populations that are likely to be involved. to benefit from the drug. But the results show that it is still possible to improve representation in industry-sponsored research, Raghav said.

"The question here is not to know where the funds come from," Raghav said. "The problem here is to do the right thing. … More efforts should be made to increase the participation of all racial subgroups. "