African Americans and Hispanics are underrepresented in cancer drug clinical trials, according to the findings of a new study published in JAMA Oncology.
Researchers of this study combed databases that reported clinical trials of FDA-approved oncology drugs between July 2008 and June 2018. They primarily utilized PubMed and ClinicalTrials.gov to identified 230 trials comprised of 112,293 participants with FDA approvals pinpointed using the administration’s archives. The researchers used National Cancer Institute-Surveillance, Epidemiology, End Results, and US Census databases to appraise US population-based cancer estimates.
The study’s primary endpoints were stipulated as the number of trials reporting race and the number of patients by race participating in trials. Secondary endpoints included race subgroup analyses, and any gaps between race proportion in trials and the US population. All data were assessed using descriptive statistics, Fisher exact, and χ2 tests, and they reported for proportions using odds ratios (OR) with 95% CIs.
Following database analysis of clinical trials, the findings showed that 145 (63.0%) trials reported on at least one race, 18 (7.8%) documented the four major races in the United States (white, Asian, black, and Hispanic), and 58 (25.2%) reported race subgroup analyses. Trials that reported on white, Asian, black, and Hispanic races was included in 144 (62.6%), 110 (47.8%), 88 (38.2%), and 23 (10.0%) trials, respectively. Moreover, between July 2008 and June 2013 vs July 2013 and June 2018, the number of trials reporting race (45 [56.6%] vs 100 [67.1%]; OR=1.63; 95% CI, 0.93 to 2.87; P = .09) and race subgroup analysis (13 [16.1%] vs 45 [30.2%]; OR=2.26; 95% CI, 1.16 to 4.67; P = .03) changed minimally and varied across races. Overall, with the number of reported US cancer incidence, blacks (22% of expected) and Hispanics (44% of expected) were underrepresented in cancer drug trials juxtaposed to whites (98% of expected) and Asians (438% of expected).
An Improvement is Needed
“Our findings show that the science might not be applicable to the population that’s going to receive the medications,” said the study’s lead author, Dr. Jonathan Loree, assistant professor in the department of medicine, division of medical oncology in a press release about the study . “If patients are going to be receiving the drug, we need to know that it’s going to work for them with the same effectiveness that’s seen in the trial.”
Although the study was conducted using US data, Dr. Loree said that the findings are also relevant to Canada because pharmaceutical companies typically submit drug approvals to Health Canada subsequent to FDA approval.
“One thing particularly relevant to the Canadian context is that we weren’t able to analyze the participation of Native Americans in trials because there were only 13 patients reported out of a total of 112,000 participants,” Dr. Loree added. “That’s shocking and definitely shows an area where improvement is needed.”