Written by Nestor Lopez-Duran, PhD 

In April of 2022, the FDA published a draft guidance for creating plans to increase diversity in clinical trials. It provided sponsors with a basic framework for how to structure the Race and Ethnicity Diversity Plan that is now expected for most clinical trials under FDA oversight. Specifically, the FDA recommends that sponsors create a plan to enroll a representative number of participants from historically underrepresented racial and ethnic groups and submit this plan with all new Investigational New Drug (IND) applications. This new draft expands on previous guidance that suggests specific protocol changes related to inclusion criteria, enrollment practices, and trial design.

The question remains, however, on how this guidance translates to real-world operations in ways that are feasible while enhancing the ultimate goal of the trial. This primer provides specific recommendations that sponsors can use during the development of their Race and Ethnicity Diversity Plans, as well as actions that study teams should follow in order to maximize the likelihood of trial success.

A Scientific And Economic Rati