FDA Expands Guidance on Gathering Race, Ethnicity Data to Observational Trials
The FDA has expanded its existing guidance on collecting race and ethnicity data in clinical research to include noninterventional, or observational, studies as well as clinical trials.
In the new draft guidance, “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products,” the agency notes that the ways race and ethnicity data are collected in clinical practice can vary considerably and thus affect the demographic data available for analysis in noninterventional studies. To account for this, “sponsors seeking to conduct noninterventional studies to support regulatory decision-making should discuss the availability of race and ethnicity data with the relevant review division,” the guidance advises.
It also includes updated references and agency contact information and editorial changes intended to provide greater clarity.
Compared to the current 16-page final guidance, which came out in October 2016, the newly issued draft guidance is considerably more concise, standing at eight pages, and makes recommendations in five areas:
- The two-question format for requesting race/ethnicity information
- Self-reporting by participants
- The use of more detailed racial/ethnic categories in certain situations, such as trials being run outside of the U.S.
Comments on the draft guidance are due by April 29.
Read the draft guidance here.