Overview
- Only 6% of the 341 Phase III trials supporting FDA approvals from 2017 to 2023 matched U.S. racial and ethnic demographics.
- Enrollment of Black and Hispanic participants declined starting in 2021, while Asian representation increased and White participation stayed largely stable.
- U.S.-site enrollment fell from about 47% in 2020 to 25% in 2023, even though U.S. sites more often enroll Black participants at Census-aligned levels.
- Because FDA accepts data from ICH member states, sponsors cluster sites in the U.S., Europe, China, and Japan, with Sub-Saharan Africa and much of Latin America hosting under 3% of pivotal trials.
- The Communications Medicine study recommends setting early diversity goals, selecting sites based on local ancestry and health needs, and collecting biosamples to detect differential drug responses.