On December 15, 2025, the U.S. Food and Drug Administration published its final guidance on *Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs. This guidance document outlines recommendations stemming from the FDA Reauthorization Act of 2017 (FDARA) mandate and is critical to ensure that new therapies are safe, effective, and accessible to representative patient populations.
Key aspects of the final guidance include, but are not limited to:
- Eliminating overly restrictive phase 2 exclusion criteria unless clinically or scientifically justified
- Enrolling participants who reflect the characteristics of the intended-use population with regard to age, sex, race, and ethnicity.
- Analyzing data on race and ethnicity to assist in identifying population-specific signals.
- Utilizing adaptive clinical trial designs to allow for pre-specified trial design changes during trial conduct
- Collaborating directly with local communities and patient advocates to address participant needs
- Expanding clinical trial sites to geographic locations with a higher concentration of underrepresented racial and ethnic patients
- Holding recruitment events during evening and weekend hours at trusted locations such as places of worship, community centers, barbershops, and beauty salons.
- Providing trial resources and documents in multiple languages
This is a positive step in fostering equity in clinical trial participation and access to potentially life-changing therapies, and is complementary to the Diversity Action Plans (DAPs) that are now required for most Phase 3 or other pivotal clinical trials under the Food and Drug Omnibus Reform Act (FDORA). DAPs must outline specific enrollment goals based on age, sex, race, and ethnicity, along with a clear rationale and strategies to achieve them.
OneWe Reach’s vision is a world where optimal health and wellbeing are realized by all. We previously provided recommendations to the sponsors of the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act, prior to the Bill’s introduction to Congress on February 3, 2022, and our organization continues to deliver programs, workshops and conferences that empower professionals to achieve meaningful global impact.
