NEW Draft Guidance from FDA – “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products”

Jan 31, 2024 | News |

Jan 31 Insight PicThe use of a standardized approach for collecting and reporting race and ethnicity data in submissions including information collected and reported from clinical trials and studies for FDA regulated medical products is essential for all medical product manufacturers. 

The updated guidance document from FDA will set out to provide FDA’s expectations for, and recommendations on, the use of a standardized approach. The use of standardized terminology for race and ethnicity helps to ensure that all data is collected and reported consistently in submissions to FDA.  This updated guidance also broadens the scope of standardized racial and ethnic terminology to non-interventional studies, such as observational studies, whereas the previous version of the guidance released in 2016 only applied to interventional studies. 

Historically, there have been differences documented in response to medical products in racially and ethnically distinct populations in the United States. These differences could be attributable to intrinsic factors (ex: genetics, metabolism, elimination, skin pigmentation), extrinsic factors (ex: diet, environmental exposure, socioeconomic status, culture) or even interactions between these factors. These factors prove to be reasons why collecting data on race and ethnicity is essential to identifying any population specific signals and/or responses to a certain medical product. 

The first recommendation from the Office of Management and Budget (OMB) Policy’s Directive 15 is to provide a minimum standard for maintaining, collecting and presenting data on race and ethnicity for Federal reporting purposes. This should include:  

Two Question Format 

a. Question 1 (answer first): Are you Hispanic/Latino or not Hispanic/Latino? 

b. Question 2 (answer second): What is your race? More than one choice is acceptable. 


a. FDA recommends that trial participants self-report race and ethnicity information and that those individuals be permitted to designate a multiracial identity to be consistent with best practices. Even if a study can access race and ethnicity data from a patient’s medical records, it is still recommended investigators and/or clinical study staff confirm the accuracy of this data with the study participant. 


a. For ethnicity, FDA recommends the following minimum choices be offered: 

    i. Hispanic or Latino  

    ii. Not Hispanic or Latino  


a. For race, FDA recommends the following minimum choices be offered: 

    i. American Indian or Alaska Native  

    ii. Asian 

    iii. Black or African American  

    iv. Native Hawaiian or Other Pacific Islander 

    v. White  

Use of More-Detailed Racial and Ethnic Categories  

a. Since the recommended race and ethnicity categories were developed in the United States, FDA recognizes these categories may not adequately describe racial and ethnic groups in other countries, especially when clinical trials enroll patients outside the United States. If more-detailed characteristics of race or ethnicity by geographic area are required to better understand trial participants, FDA recommends following the 2011 Health and Human Services (HHS) “Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status.” This HHS guidance provides expanded Hispanic or Latino, Asian, and Native Hawaiian or Other Pacific Islander categories for trial participants to describe their race and ethnicity more accurately. 

Sponsors should note the term nonwhite is unacceptable for use in Federal Government data as stated by OMB Policy Directive 15. FDA recommends that for all INDs, NDAs and BLAs, the submission of demographic data for all new clinical trials and studies be tabulated using the characterizations of race and ethnicity described in the guidance. Applicants should also include race and ethnicity information in their proposed product labeling, including the baseline demographics of the studied safety and efficacy populations. Sponsors should direct questions or concerns regarding the collection of race or ethnicity categories with the appropriate review division. 

Don’t forget that FDA will accept any electronic or written comments on the draft guidance up to 29 April 2024.  

Use the link below to submit any electronic comments! 

For a further look, the full draft guidance can be found at the link below: 

Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products | FDA 

Sarah Boynton, Associate Consultant and Ava Carr, Content Creator