10 January 2023 - Encouraging researchers and sponsors to simplify clinical trials and employ a fit for purpose protocol is one way that the US 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).
The FDA has been focused on increasing clinical trial diversity, issuing draft guidance in April 2022 that calls on sponsors to develop a Race and Ethnicity Diversity Plan to enrol adequate numbers of trial participants from underrepresented racial and ethnic populations in the US.