FDA Publishes Updated Draft Guidance on Clinical Trial Diversity

1. Draft Guidance Issued: The FDA has published an updated draft guidance on clinical trial diversity, aiming to increase the representation of underrepresented populations in clinical trials.
2. Requirements: The guidance outlines the format, content, and submission process for diversity action plans, which are required for large Phase 3 trials and other pivotal clinical studies.
3. Goals and Strategies: Companies are expected to set recruitment goals for different racial groups, stratified by age and gender, and explain their strategies for achieving these goals.
4. Public Comment Period: The public has three months to provide feedback on the draft guidance before the FDA finalizes it.
5. Implementation Timeline: The final guidance will be effective six months after its publication, and companies starting enrollment after that date will be required to submit diversity action plans.
6. Background: The guidance is part of the FDA's efforts to address the chronic lack of diversity in clinical research, as mandated by the Food and Drug Omnibus Reform Act of 2022.