The US Food and Drug Administration (FDA) issued draft guidance yesterday recommending clinical trial sponsors develop a “Race and Ethnicity Diversity Plan” to ensure representative enrollment of racially and ethnically diverse participants in clinical trials developing medical products.
The draft guidance, Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry, updates previous FDA guidance issued in October 2016. The “Race and Ethnicity Diversity Plan” is recommended for studies submitting IDE or IND applications to the FDA for approval of an investigational drug or device. The updated guidance provides information about 5 elements that should be included in the plan:
- Overview of the disease/condition
- Scope of medical product development program
- Goals for enrollment of underrepresented racial and ethnic participants
- Specific plan of action to enroll and retain diverse participants
- Status of meeting enrollment goals
Achieving heath equity for underrepresented racial and ethnic populations starts with appropriate representation in clinical trials. Disease burden is often higher for underrepresented populations, yet barriers to participation in clinical trials may prevent adequate enrollment. Improving racial and ethnic diversity in clinical trials ensures that results are generalizable and medical discoveries are safe and effective for all patients.
The draft guidance was a collaborative effort between the Oncology Center of Excellence’s Project Equity, the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health.
Read the FDA news release.