"After years of #FDA issuing guidance documents and launching programs to encourage sponsors to seek broader representation in #clinicaltrials, policy makers have added a “stick” to the process: research sponsors now will be required to tackle this issue by submitting Diversity Action Plans (DAPs) to the agency when proposing and seeking approval of Phase III and pivotal studies."

https://www.pharmtech.com/view/clinical-trial-diversity-continues-to-face-challenges