The US Food and Drug Administration (FDA) recently updated its 2005 guidance detailing its expectations sponsors for collecting race and ethnicity data in clinical trials for drugs, biologics and medical devices.

According to the agency, the guidance has been updated to reflect a standardized approach to collecting race and ethnicity data in accordance with requirements under the 2010 Affordable Care Act (ACA)and the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA).

Under Section 4302, the ACA established new requirements intended to improve the understanding of health disparities, including requirements for standardization, collection, analysis and reporting of demographic data.

Then, under Section 907 of FDASIA, FDA was required 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.

The report 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," FDA wrote. 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.

In 2014, FDA held a public hearing to get feedback on the findings of the report, which it incorporated into an action plan to enhance the collection of subgroup data that set forth three priorities for the agency:

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

Updated Guidance

According to FDA, its updated guidance is intended to support the action plan by clarifying its expectations for how race and ethnicity data is collected.

In general, FDA says it 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.

FDA also provides a more detailed list of racial and ethnic categories, which is says may be more appropriate for studies conducted outside the US, referring to data standards developed by the Department of Health and Human Services in 2011.

Figure 1. More Detailed Characterization of Race and Ethnicity

FDA also reminds sponsors that applications for both drugs and biologics will be required to be submitted electronically using the electronic common technical document (eCTD) beginning in May 2017. However, while FDA refers sponsors to the International Council on Harmonisation's (ICH) M4E guidance on formatting demographic data, the agency asks that sponsors use the categories for race and ethnicity in its updated guidance, as they "provide greater detail."

FDA