Are Important Clinical Trials Racially Balanced?

With growing interest in health equity, it is reasonable to inquire about the representation of minorities in the pivotal clinical trials used to approve drugs. Accordingly, investigators determined the participation of Black U.S. residents in studies used to support the FDA's approval of 24 new molecular entity cardiovascular drugs from 2006 through 2020.

The trials had a total of 187,294 participants, including 5396 Black participants or 2.9% of the clinical trial population. The participation-to-prevalence ratio (PPR), which conveys how trial participation compares with the proportion of people in the disease population, was 0.29 — a number that indicates Black people were markedly underrepresented. The lowest PPR among the seven cardiova…