Racial Reporting and Representation in Oncology Trials
New research published by Loree et al in JAMA Oncology found that race and race subgroup analysis reporting does not occur frequently and that black and Hispanic populations are underrepresented in oncology trials that have led to U.S. Food and Drug Administration (FDA) approvals. The study raises concerns about the effectiveness of cancer drugs in some patients, especially since genetic differences may affect how well a patient responds to a drug.
Researchers reviewed all reported trials supporting FDA oncology drug approvals granted between July 2008 and June 2018. They studied 230 trials with a total of 112,293 participants and then calculated the U.S. population-based cancer estimates by race using National Cancer Institute and U.S. Census data.
Analysis Results
The researchers found that 145 of the 230 trials analyzed (7.8%) documented the four major races in the United States—white, Asian, black, and Hispanic—between 2008 and 2018. Fifty-eight of the 230 trials (25.2%) reported conducting race subgroup analyses. Reporting on white, Asian, black, and Hispanic races was included in 62.6%, 47.8%, 38.2%, and 10% of the analyzed trials, respectively.
Compared with their proportion of cancer incidence in the United States, black and Hispanic patients were particularly underrepresented—at 22% of expected and 44% of expected, respectively—compared with white and Asian patients. The researchers also found that both reporting about race in trials and enrollment rates had changed minimally over the decade.
“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 Jonathan Loree, MD, in a statement. “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.”
Researchers are now looking at whether clinical trials represent the same gender ratio as the general population to ensure the drugs are effective in all people. They concluded, “Race and race subgroup analysis reporting occurs infrequently, and black and Hispanic races are consistently underrepresented compared with their burden of cancer incidence in landmark trials that led to FDA oncology drug approvals. Enhanced minority engagement is needed in trials to ensure the validity of results and reliable benefits to all.”
Disclosure: For full disclosures of the study authors, visit jamanetwork.com.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
