New FDA Rules for Collecting Ethnicity Data

The FDA wants to improve the way researchers collect race and ethnicity data in clinical trials.

On October 26, 2016, the agency updated guidance documents to reflect requirements under the 2010 Affordable Care Act (ACA) and the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA).

Citing a 2008 study by SM Huang and R Temple, the agency said differences in response to medical products have already been observed in racially and ethnically distinct subgroups of the U.S. population. These differences may be attributable to intrinsic factors (e.g., genetics, metabolism, elimination), extrinsic factors (e.g., diet, environmental exposure, sociocultural issues), or interactions between these factors.

The new guidelines include requirements for standardization, collection, analysis and reporting of demographic data. The laws also required the FDA to publish a report looking at the extent to which industry was meeting requirements for diversity in clinical trial participation and analysis by demographic subgroups in applications submitted to the agency.

In that report, according to the Regulatory Affairs Professional Society (RAPS), the agency found inconsistencies in the clinical trial participation, reporting, and analysis, particularly when it came to race.

“Whites represented a high percentage of clinical trial study participants for biologic, drug and medical device applications. In many cases, other racial subgroups were underrepresented, ” wrote the FDA. The agency also noted that medical device submissions were less likely to include a subgroup analysis for race and ethnicity than those for drugs and biologics.

After a public hearing about the report in 2014, the agency incorporated the following action plan:

• Improve the completeness and quality of demographic subgroup data collection, reporting and analysis.
• Identify barriers to subgroup enrollment in clinical trials and employ strategies to encourage greater participation.
• Make demographic subgroup data more available and transparent.

The FDA recommends sponsors use a two-question approach to requesting race and ethnicity information from clinical trial participants:

• Question 1 (answer first): Do you consider yourself Hispanic/Latino or not Hispanic/Latino?
• Question 2 (answer second): Which of the following five racial designations (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, White) best describes you? More than one choice is acceptable.

To review the full guidance document, click here.