New Benchmarks on Demographic Disparities in Pivotal Trials Supporting FDA-Approved Drugs and Biologics.

Reporting of demographic data has improved significantly for all three demographic categories (sex, racial identity, and ethnic identity) over the observed time period (p < 0.0001). During this time period, overrepresentation of white participants has decreased significantly (p < 0.0001), and representation of Black participants has increased (p = 0.0003). Other racial and ethnic identities did not show significant trends. Representation of demographic subgroups was not significant predictors of trial duration except for the representation of Black participants, which was a negative correlation, indicating that as representation of Black participants increases, trial duration decreases (p = 0.0350).