FDA Guidance For Diversity In Clinical Trials: What You Need To Know

By Taylor Davidson, Florence Healthcare

The FDA’s newest guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials,” took the clinical research world by storm. 

While diversity, equity, and inclusion have been major focuses for clinical research teams for a long time, sponsors and sites were excited and surprised to receive explicit FDA guidance in April 2022. 

But what do clinical research teams need to know from the guidance, and how can we prepare to incorporate it?