Overview
- The analysis reviewed 341 Phase III pivotal trials supporting FDA approvals from 2017 to 2023 using FDA Drug Trial Snapshots data.
- Enrollment of Black and Hispanic participants declined starting in 2021, while Asian participation rose and White levels stayed largely stable.
- Sub-Saharan Africa and much of Latin America account for less than 3% of pivotal trials, with most sites concentrated in the U.S., Europe, China, and Japan.
- U.S.-based sites are more likely to enroll Black participants at Census-aligned levels, yet the share of U.S.-enrolled patients fell to 25% in 2023 from 47% in 2020.
- The authors recommend early diversity targets, broader site selection, and routine biosample collection, noting expanded ICH membership in Brazil, Mexico, and Argentina could aid future inclusion.