A group of people from different ethnic background standing, watching tabs and phones

Revised guidance from the US Food and Drug Administration (FDA) sets clear expectations and provides standardized recommendations for collecting and reporting race and ethnicity data in clinical trial submissions, underscoring the agency’s commitment to ensuring clinical research is as inclusive and representative as possible.

By Lya Rebelo, Manager, Commercial Enablement

In a significant move to foster diversity in clinical trials, the US Food and Drug Administration has released draft guidance titled “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products.” This guidance,1 issued January 2024, is an update to the previous2 guidance from Oct. 26, 2016, underscoring the FDA's commitment to ensuring clinical research is as inclusive and representative as possible.

The revised guidance sets clear expectations and provides standardized recommendations for collecting and reporting race and ethnicity data in clinical trial submissions. This effort supports FDA-regulated medical products and aligns with broader efforts to acknowledge and address diversity in clinical research.

Why Is This Update Important?

Diversity in clinical trials is crucial for understanding how medical products perform across different demographic groups. The updated guidance emphasizes the use of standard terminology for age, sex, gender, race, and ethnicity, ensuring consistent collection of subpopulation data. This approach is rooted in the Office of Management and Budget (OMB) Directive 15 and is further shaped by the Affordable Care Act, the Department of Health and Human Services (HHS) Implementation Guidance on Data Collection Standards, and the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907 Action Plan.

Key Changes and Recommendations:

The new guidance expands its scope to include both non-interventional (observational) studies and the interventional clinical trials discussed in the 2016 guidance. It also introduces editorial updates for clarity, revised titles, and the latest contact information for the FDA.

Specific recommendations include:

  • Adhering to the 1998 final rule regarding the presentation of demographic data in investigational new drug applications and new drug applications.
  • Ensuring the collection of race and ethnicity data in biologics license applications (BLAs) and medical device applications.
  • Following the FDASIA Section 907 Action Plan to enhance the completeness and quality of demographic data collection and reporting.

In light of ongoing demographic shifts in the United States, the FDA anticipates further updates to this guidance following any revisions to OMB Policy Directive 15. These efforts reflect a dynamic approach to evolving societal, political, and economic factors impacting clinical research.

How to Participate in the Discussion

The FDA invites public commentary on this draft guidance until April 29, 2024. Stakeholder feedback is invaluable for refining the guidance before the final version is developed. This open dialogue ensures that diverse perspectives shape a more inclusive clinical trial data collection approach.

Submit your comments here to make your voice heard and support the FDA's mission to enhance diversity in clinical trials, ultimately leading to safer and more effective medical products for everyone.

Want to learn more about the FDA’s recent activities to increase diversity in clinical trials?

Read our previous article.

1 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/collection-race-and-ethnicity-data-clinical-trials-and-clinical-studies-fda-regulated-medical

2 Collection of Race and Ethnicity Data in Clinical Trials

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