The globalization of cancer clinical trials resulted in fewer Black patients being enrolled, further widening the racial gap in cancer clinical trials, a study suggests.
“There have been a number of studies investigating factors such as access to healthcare, physician biases, and socioeconomic status that may lead to underrepresentation of Black patients,” said Serena Tharakan, BS, of the Icahn School of Medicine at Mount Sinai in New York City, in a press release. “However, to our knowledge, our findings are the first to quantitatively demonstrate that the globalization of cancer clinical trials may also be a key driver of racial disparities in the U.S. drug approval process.”
The study evaluated 35 cancer drugs (49 global clinical trials) that received U.S. Food and Drug Administration (FDA) approval between 2015 and 2018, with each approval receiving a disparity score to compare Black enrollment in clinical trials versus the estimated burden of disease in Black patients.
Overall, Black patients consisted of 2.5% of enrollment across the 49 global clinical trials (range, 0-10%). The median disparity score was 0.19 (range, 0.01-0.98). In 21 clinical trials (for 18 FDA drug approvals), 64% of patients were enrolled outside the United States (Range, 0-100%). Black patients made up 3.2% of enrollment (range, 0.2-10%); the median disparity sore was 0.23 (range, 0.01-0.98). The proportion of trial patients enrolled internationally was inversely associated with disparity score (Pearson correlation, –0.61; P=0.007).
The study was published in Cancer.
“The globalization of cancer clinical trials is associated with a widening racial enrollment disparity gap in the United States. The impact of global trials on domestic clinical trial generalizability warrants further consideration from a regulatory and policy standpoint,” the researchers wrote in their conclusion.
Recently, researchers from the Dana-Farber Cancer Institute, FDA, and American Association for Cancer Research issued new guidelines aimed at increasing Black representation in clinical trials for multiple myeloma. Black patients are disproportionately at a greater risk for multiple myeloma but are largely underrepresented in clinical trials.
Among the suggestions are broadening eligibility criteria whenever possible, requiring trial sponsors to complete diversity study plans to set enrollment targets, appointing a diversity officer to aid with trial design and recruitment, and continuing to gather data on racial and ethnic differences in treatment safety and efficacy during the post-approval period.
“The number of African Americans enrolled in clinical trials of novel agents or treatments of multiple myeloma has been tragically low. When they have enrolled, their outcome to treatment with novel therapies has been the same or even better than other patients,” said co-author Kenneth C. Anderson, MD, medical oncologist at Dana-Farber and program director of the Lebow Institute for Myeloma Therapeutics and the Jerome Lipper Multiple Myeloma Center, in a press release.
