The FDA's Diversity Action Plan (DAP) guidance has moved to the White House Office of Information and Regulatory Affairs for final review.
Under new legislation, sponsors of certain clinical trials must develop and submit a Diversity Action Plan showing how their study populations will reflect the diversity of the United States.
The requirement responds to the long-standing underrepresentation of some groups in clinical trials, which can produce biased results. Plans will address areas such as race, ethnicity, age, gender, and socioeconomic status, with the aim of improving recruitment and retention of underrepresented groups.
Once the guidance is final, sponsors can use it to build more representative trials.