NEW YORK (Reuters Health) – Black patients remain underrepresented in U.S. clinical trials despite the Food and Drug Administration (FDA)’s 2015 launch of a five-year plan to improve the situation, a new study finds.
An analysis of data posted on Drug Trials Snapshots from 2014 to 2021 revealed that the relative representation of Black participants to whites remained static, researchers report in Health Affairs.
“Clinical trials generate data for the regulatory approval and widespread use of new drugs and drug indications in the U.S.,” said first author Dr. Angela Green, a medical oncologist at Memorial Sloan Kettering Cancer Center in New York.
“It is imperative that clinical trial participants represent the broader population of patients that receive these treatments to ensure that the drugs are safe and beneficial for all,” Dr. Green told Reuters Health by email.
The data extracted from the FDA’s Snapshots program included the drug’s name, the manufacturer, the approval date, the indication, the National Clinical Trial identifier number, the trial start date, the numbers of Black and white participants, and racial differences, if any, in benefits and side effects.
During the study period, Drug Trials Snapshots posted 290 drugs with 293 drug indication combinations. Disease-burden information was available for 225 of the drugs and 232 of the drug-indication combinations. The analysis focused on the 225 drugs.
The researchers found that Black participants were underrepresented in 85% of the trials and in all disease categories except for psychiatry. They note that this exception was largely driven by one drug: lumateperone.
Trials for cardiovascular disease treatments had the lowest Black participation. Overall, the trials had a median of one-third the enrollment that would be required, whether the trials started before, during or after the action plan, the researchers note.
There’s no question that more diversity is needed in clinical trials, said Dr. Otis Brawley, professor of oncology and epidemiology at the Johns Hopkins School of Medicine and the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland.
“And we need to keep an eye out for side effects and how various populations respond to our medications,” Dr. Brawley told Reuters Health by phone. “Race, however, is a socio-political categorization, not a biological categorization. The FDA rules imply that race is biological. To assume race is biological is racist.”
Rather than race, researchers should be focusing on diversity based on geographic origin, Dr. Brawley said.
“My favorite example of this is sickle-cell disease,” he added. “About 50,000 people are born each year with the trait and about 8,000 to 10,000 of them are white. We think of sickle cell as a Black or African disease. The truth is, people from Southern Italy, Greece and going into Syria and Lebanon have this trait.”
The downside of rules that focus on race is “they have the potential of creating a situation where doctors and nurses give Black patients the hard sell and white patients the option,” Dr. Brawley said.
SOURCE: https://bit.ly/367glhZ Health Affairs, online March 7, 2022.
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