Advancing Health Equity: Boosting Diversity in Clinical Trials

Medical products achieve superior safety and efficacy profiles when clinical research enrolls demographically diverse populations that mirror real-world patients.

Section 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA) mandated the FDA to evaluate the extent to which applications for drugs, biologics, and devices include:

1) Adequate representation of sex, age, race, and ethnicity in pivotal clinical trials; and
2) Subgroup-specific analyses of safety and effectiveness data.

Evaluating investigational therapies in the populations ultimately intended for use is essential for generating generalizable evidence. The FDA therefore promotes inclusion across age, racial, ethnic, and gender strata. The resources below summarize how diverse communities participate in medical-product clinical trials.

The Office of Minority Health coordinates cross-center working groups to design and implement strategies that reduce health disparities.

• FDASIA Section 907 required FDA to deliver to Congress a data-driven action plan outlining “recommendations for improving the completeness and quality of analyses of demographic-subgroup data in summaries of product safety and effectiveness, in labeling, and in public communications to patients, clinicians, and researchers,” while identifying the FDA centers responsible for each recommendation. Congress stipulated that the plan be issued within one year of the Section 907 report’s publication.
• Additional details on CERSI (Centers of Excellence in Regulatory Science and Innovation)
• Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data
• Questions and Answers about Section 907
• Drug Trials Snapshots: These summaries inform consumers about the demographic composition of trials supporting new drug approvals and highlight any sex-, race-, or age-related differences in efficacy or adverse-event profiles, advancing FDA’s commitment to transparent demographic data dissemination.

More Information on Diversity in Clinical Trials

Further reading:

• Ethical standards for clinical research diversity
• Subgroup analysis in pivotal clinical trials
• FDA demographic data action plan
• Why clinical trials need diversity
• Clinical trial participation overview

• Men During Their Reproductive Years
  Enables men—previously excluded over reproductive safety concerns—to enroll in life-saving clinical trials.
• Women
  Learn how the FDA Office of Women’s Health advances gender diversity in clinical research.
• Minority Health Resources
  Explore FDA initiatives on safe medication use, diabetes management, food safety, HIV/AIDS therapies, and inclusive clinical trials.
• Racial/Ethnic Groups
  Examines 1995–1999 enrollment trends to improve representation of racial and ethnic populations in clinical studies.
• NIH Office of Equity, Diversity, and Inclusion
  Supports sexual and gender minority inclusion across the biomedical research continuum.
• Older Adults
  Outlines the benefits and safety considerations for geriatric participation in clinical trials.
• Children
  Consumer update detailing when pediatric clinical trials may offer optimal therapeutic options.

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Further reading:

• Clinical trial equity
• Diversity in clinical trials
• Enhancing diversity in clinical trial populations
• Who participates in clinical trials
• Clinical trials overview