FDA’s Updated Draft Guidance on Reporting of Diversity Data in Clinical Trials

In January 2024, the FDA released an updated draft guidance titled “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products”. This is an update to the current published guidance “Collection of Race and Ethnicity Data in Clinical Trials” which was released on 26 OCT 2016. You can find the FDA’s discussion and a link to the draft document here. 

*Note that the FDA uses the term Medical Products generically to encompass all drugs, including biologics and devices, as described in the Federal Food, Drug and Cosmetic Act (FD&C) 21 USC 301 – 392.

The purpose of the update is to reflect the FDA’s current guidance for standardizing the approach to collect and report race and ethnicity data in submissions from clinical trials and clinical studies. It is important to use standardized classifications when reporting such data to ensure that the metrics can be captured consistently by the FDA and used for safety and efficacy data in clinical trials and clinical studies. The comment period for this draft guidance will end on 29 APR 2024. 

The Latest Changes

The following changes are included in the draft guidance: the title, references within the document, FDA contact information, and reorganization of information. It should be noted that the FDA follows the OMB Policy Directive 15 and will continue to update its stance as Policy Directive 15 is updated.

The approach to discern and report race and ethnicity data remains the same. The FDA continues to recommend the use of the two-question format and self-reporting for ethnicity. The first question is a direct confirmation “Do you consider yourself Hispanic/Latino or not Hispanic/Latino?”. The second question allows the participant to select one or more racial designations from the five accepted choices: American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander and White. The FDA continues to encourage participants to self-report their race and ethnicity information. If the participant is unavailable or declines to respond, the FDA recommends obtaining the information from a first-degree relative or another knowledgeable source. Race and ethnicity should not be assigned by the study team conducting the trial. 

If a more detailed breakdown is required for marketing the medical product, submission requirements, or any other reason, the FDA recommends the categories described in the current guidance, the draft guidance, and the 2011 HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status. The breakdown is detailed below.

Ethnicity Data Standard  

Are you Hispanic or Latino? (One or more categories may be selected.)

•       No, not Hispanic or Latino
•       Yes, Mexican, Mexican American, Chicano
•       Yes, Puerto Rican 
•       Yes, Cuban
•       Yes, Other Hispanic or Latino

Race Data Standard  

What is your race? (One or more categories may be selected.) 

•       White
•       Black or African American 
•       American Indian or Alaska Native
•       Asian Indian 
•       Chinese
•       Filipino 
•       Japanese 
•       Korean 
•       Vietnamese
•       Other Asian
•       Native Hawaiian
•       Guamanian or Chamorro 
•       Samoan
•       Other Pacific Islander

It has been highlighted in the previous guidance and the current draft that the term “nonwhite” is  unacceptable for any Federal Government data. The data collected should be submitted for all new clinical trials and clinical studies. The FDA also recommends using demographic data when developing product labeling. In addition, adverse reactions should include the baseline demographics of the safety population.

The Importance of Diversity in Medicine

While reporting ethnicity and race can be a sensitive topic for some, it is important to do so in a consistent and uniform manner. In the past, clinical trials and studies were conducted primarily on one race and one sex, providing only limited data for that population. As medical products become more advanced and the scope becomes more global, clinical trials and studies must also become more diverse. In doing so, it can improve known information and data on the effectiveness and reliability of medical products for global (and local) races and ethnicities.

Diversity becomes a key point to demonstrating whether the medical product will or will not be safe and effective for the target demographic. This is giving rise to many international regulatory bodies requiring clinical trials and clinical studies on their populations to assure safety and efficacy. 

*The link to the docket to submit comments or view current comments can be found here.