Analysis: FDA’s Five-Year Diversity Strategy Fell Short for Black Patients
Despite pushing for greater clinical trial participation of minority patients via a five-year action plan, the FDA’s efforts appear to have made little difference for Black patients, the latest analysis has found.
The FDA plan was launched in 2015 to improve the diversity of pivotal trials of newly approved drugs to make trials more representative of the U.S. population. But after evaluating May 2014 to July 2021 data from the FDA’s Drug Trials Snapshots, which offer information on trial participant demographics, researchers with the Memorial Sloan Kettering Cancer Center found that Black participation has remained low despite the agency’s initiative.
The findings, published in HealthAffairs, should be an impetus for bolder action by the FDA to achieve trial diversity, the researchers wrote. Specifically, they advise that the agency consider enacting minimum thresholds for underrepresented patient populations, particularly in later-phase trials, to ensure all racial and ethnic groups are adequately represented.
“These findings suggest that the FDA should consider a new approach to improving clinical trial representativeness, reaching beyond reporting- and transparency-centered measures to implement representational requirements,” they wrote.
In all disease areas except psychiatry, Black participants were found to be underrepresented; tellingly, 85.3 percent of trials did not have a Black population that closely mirrored their makeup of the U.S. population. This disparity was the strongest in cardiovascular disease trials, the researchers found, even though Black patients were 30 percent more likely to die from heart disease than nonHispanic Whites in 2018, according to HHS.
In addition, the analysis found that less than 20 percent of the drugs assessed had data about treatment benefits or side effects in Black patients; these data did not increase as intended by the FDA’s diversity action plan.
For each drug’s indication, the researchers compared the proportion of Black and White patients in the trial with the proportion of disease Black and White patients experience in the real-world population, excluding indications that lacked enough data to estimate disease burden. Of the 290 drugs posted on Drug Trials Snapshots, 225 of them had disease burden data available for assessment and comparison.
The findings showed that Black underrepresentation in trials was present both before and after the agency’s five-year plan, suggesting that the plan did not achieve its goals.
The FDA said that it remains focused on increasing the diversity of clinical trial populations “by hosting public meetings, developing tools and issuing guidance documents to support diverse participation in clinical trials.”
There is currently a draft guidance pending review at the Office of Management and Budget that will detail diversity plans for improving enrollment of underrepresented populations. It’s not yet clear when that guidance will be published.
Access the study here: https://bit.ly/3hS54F6.