Black patients consistently underrepresented in pivotal CVD trials
In contrast to their prevalence in the overall disease population, Black individuals were considerably underrepresented in trials that affirmed the FDA’s approval of 24 CVD treatments, researchers reported.
According to data published in JAMA Network Open, individuals of white race/ethnicity were overrepresented in more than half of the CVD clinical trials included in the analysis.
“Given that clinical trials provide the foundational evidence that helps shape guideline recommendations for physicians and support approval of new drugs by the FDA, equitable representation of Black U.S. residents in clinical trials is vitally important,” wrote Siliang Chen, MD, and Jiarui Li, MD, of the department of medical oncology at Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences and Peking Union Medical College in Beijing. “Therefore, this study was designed to investigate the representation status of Black U.S. residents in crucial clinical trials supporting FDA approval of cardiovascular drugs.”
For this cross-sectional analysis, researchers included trials of 24 drugs approved for hypertension, CAD, ACS or MI, HF, atrial fibrillation, pulmonary arterial hypertension or hypercholesterolemia by the FDA from 2006 to 2020.
Researchers sought to determine the representation status of Black and white U.S. residents in CVD drug trials using a participation to prevalence ratio (PPR). A PPR of 0.8 to 1.2 meant the proportion of Black and white participants in a trial was similar to their proportion in the overall disease population. Anything less than 0.8 or greater than 1.2 signified under- and overrepresentation.
Total enrollment across all trials was 187,294 participants, of whom 2.9% were Black and 83.1% were white.
According to the study, the PPR was less than 0.8 for Black participants in every clinical trial.
Researchers found that the highest PPR for Black participants was 0.52 for hypertension trials and the lowest PPR was 0.072, observed in hypercholesterolemia trials.
“Our findings show that Black U.S. residents were underrepresented as participants in clinical trials supporting FDA approval of cardiovascular drugs, whereas white U.S. residents were equally represented and even overrepresented,” the researchers wrote. “This marked underrepresentation might undermine the generalizability of use of new CVD drugs in Black U.S. residents.”
The total PPR for white participants in all trials was 1.14.
For white participants in trials of ACS or MI, CAD, HF, hypertension and hypercholesterolemia, PPRs were greater than 1.2, indicating overrepresentation.
“Although substantial efforts have been made to reduce racial inequity in clinical trials participation, previous studies have indicated that the enrollment of Black U.S. participants in CVD trials was still disappointing and that significant racial disparities have persisted over the past 15 years,” the researchers wrote. “More effective strategies (eg, a 10% to 50% accrual rate of minority groups in clinical trials) are required to enhance the enrollment of Black participants in CVD clinical trials.”
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