FDA increases racial and ethnic diversity in clinical trials

FDA issued a draft guidance document for developing plans to enroll more participants in clinical trials from underrepresented racial and ethnic populations. The draft guidance advises sponsors of medical products to develop and submit a race and ethnicity diversity plan based on a framework outlined in the guidance to the agency early in clinical development.

Obstacles to participation among racial and ethnic groups may include language and cultural differences, suspicions about the clinical research system, insufficient trial recruitment and retention efforts, and caregiver or family responsibilities, according to FDA.

To support FDA’s goal of advancing more diverse participation, the Office of Minority Health and Health Equity created the Diversity in Clinical Trials Initiative, which features ongoing public education and outreach efforts.

The initiative also uses several culturally and linguistically customized resources, tools, and strategies, including educational materials in multiple languages and a dedicated webpage with public service announcements and videos.

One of the targets of the Biden administration’s Cancer Moonshot program is to curb disparities in access to cancer screenings, diagnostics, and treatment. The draft guidance was developed by the Oncology Center of Excellence’s Project Equity, which aims to ensure that the data submitted to FDA for approval of oncology medical products adequately reflect the demographic representation of participants for whom the medical products are intended.