A new draft guidance from the FDA calls on sponsors to submit detailed plans for achieving racial/ethnic diversity in their trials as part of their investigational new drug (IND) or investigational device exemption (IDE) applications.

The 12-page draft guidance, issued last week, is the latest move in the agency’s drive to increase clinical trial participation in minority populations. The agency says it “will evaluate the race and ethnicity diversity plan as an important part of the sponsor’s development program.”

The guidance outlines the key components of a diversity plan, beginning with an overview that describes the available pathophysiology data in underrepresented racial and ethnic populations for the disease or condition to be studied. Different applications or uses of currently available prevention, screening or diagnostic strategies and treatments should be described and known similarities or differences in disease/condition among the underrepresented population should be discussed.

A section on the scope of the clinical development program should briefly describe the planned trial and how it would address the inclusion of underrepresented populations, including details on study design, study population, eligibility criteria, endpoints and the expected geographic trial locations. This section also should describe, if applicable, any differences found in clinical pharmacology studies for the racial and ethnic groups to be studied.

Sponsors should include their goals for enrolling a diverse population and outline the specific plan to achieve these goals as well as the measures that will be taken to both enroll and retain minority participants and describe the way data will be used to characterize safety, efficacy and, if applicable, optimal dosage in these participants.

Lastly, the plan should discuss the status of the sponsor’s enrollment goals as the plan is updated, when applicable, and should include collecting data postmarket if diversity goals are not met, the guidance says.

For sponsors holding INDs, the diversity plan should be submitted “as soon as practicable” during development, the guidance says, but before the sponsor has requested feedback from the agency on a pivotal trial. For devices, sponsors should submit the diversity plan as part of the IDE application. If device sponsors wish to hash out their enrollment strategy with the FDA before submitting the plan or discuss a plan for a non-IDE trial, they should follow the agency’s Q-Submission process for requesting a meeting or feedback.

Applications for marketing authorization also should include the sponsor’s trial diversity plan as well as an outline of the challenges and successes they had in implementing it.

Comments on the draft guidance are due by June 13.

Read the draft guidance here: https://bit.ly/3vfLLvI.