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

April 29, 2024

FDA-2016-D-3561

We appreciate the opportunity to comment and support the FDA’s proposed rule regarding: the “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products.”

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies, treatments and products are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest. 

NCHR supports the implementation of these updated definitions to reflect the racial diversity of the U.S. population for which these medical products are being tested. As discussed in the draft guidance document lines 93-99, racial and ethnic signals may influence the safety, efficacy and use of specific medical products.  Unfortunately, the impact of race and ethnicity is often unproven because of lack of diversity in clinical trials as well as outdated categories and definitions of race and ethnicity. The use of updated, standardized terminology for ethnic and racial self-classifications can improve the evaluation of disparities or differences in the utilization, efficacy, and safety of different medical products. Therefore, ensuring consistency in the collection of such data is crucial to improve the approval process of medical products.

We support the use of self-reported ethnicity and racial information from study participants. We also support the expanded ethnicity data standard; however, we urge the FDA to also expand upon the Office of Management and Budget’s (OMB) race data standard, as discussed in section E of the draft guidance document. The enhanced data standard should be used in all applicable cases since additional and more specific categories of race can help clarify how participants identify their race. While not included in the enhanced OMB standard, we also urge the FDA to consider the addition of Middle Eastern and North African (MENA) as an option for race, because it more accurately reflects how these populations typically self-identify (rather than Asian, African, or White). Participants should also be encouraged to self-identify in as many categories as they deem appropriate. Current OMB standards are specific to the way the U.S. chooses to define race and ethnic groups, which is not always comparable to how individuals self-identify in the U.S. or in other countries. 

While this draft guidance labels the proposed initiative as “recommended,” we urge FDA to make these categories mandatory. We also support the inclusion of racial/ethnic groups in medical product labeling in addition to including information for intended use based on sex and age group. The meaningful use of these data would require that clinical trials are conducted on a diverse and representative sample of the patient population (across age, sex, ethnicity, and race) that these medical products aim to benefit.  Statistically meaningful results of a trial require adequate diversity to conduct appropriate subgroup analyses evaluating efficacy and safety. This draft guidance does not make recommendations to sponsors to ensure that trials reflect their target patient population. FDA should provide meaningful incentives to ensure sponsors comply with these guidelines.

Disparities in safety and efficacy related to race and ethnicity have been obscured due to insufficient data. Proper collection and reporting of racial and ethnic data represent a vital first step toward addressing this gap in understanding. However, the FDA should do more to incentivize greater racial and ethnic diversity in clinical trials used as the basis of FDA approval decisions, in order to ensure that FDA approvals do not contribute to disparities in medical treatment by failing to determine racial and ethnic differences in safety and efficacy.

The post NCHR Comment on Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products appeared first on National Center for Health Research.