Encouraging researchers and sponsors to simplify clinical trials and employ a fit-for-purpose protocol is one way that the US Food and Drug Administration (FDA) can promote recruitment of trial populations that are racially and ethnically diverse, according to Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research (CDER).
FDA has been focused on increasing clinical trial diversity, issuing draft guidance in April 2022 that calls on sponsors to develop a Race and Ethnicity Diversity Plan to enroll adequate numbers of trial participants from underrepresented racial and ethnic populations in the United States (RELATED: FDA recommends sponsors plan to include race, ethnicity in clinical trial design, Regulatory Focus 13 April 2022). While guidance is one of the agency’s tools to increase diversity, Cavazzoni said FDA can also encourage the use of innovative trial designs…
