The U.S. Food and Drug Administration (FDA) continues its efforts to include diverse participants in clinical research, releasing a new revised draft guideline titled “Collecting Racial and Ethnic Data in Clinical Trials.” and provides recommendations regarding standardized data. Collection of racial and ethnic data. As we continue to await FDA guidance on a diversity action plan, this latest guidance suggests that FDA is laying the groundwork for additional guidance to promote diversity in clinical trials. FDA is seeking comments on this draft guideline until April 29, 2024.
FDA originally published final guidance on racial and ethnic data collection in clinical trials in 2016 in response to the Office of Management and Budget’s (OMB) Statistical Policy Directive 15, Revised Standards for Classification of Federal Data on Race and Ethnicity. Announced. , was developed to provide a common framework for uniformity and consistency in the collection and use of race and ethnicity data by federal agencies. OMB stated that the recommended racial and ethnic categories are not anthropological or science-based designations, but instead are categories that describe the sociocultural structure of our society. FDA’s updated guidance was prompted in part by the OMB-initiated review of OMB Policy Directive 15.
FDA’s new Revised draft guidance Much of the content from the 2016 version has been retained. This maintains the original intent of FDA’s 2016 recommendation to sponsors regarding the presentation of demographic data. Improve the completeness and quality of demographic data collection and reporting in drug, biologic, and device marketing applications. This version also streamlines the 2016 guidance by removing much of the historical context that gave context to FDA’s recommendations.
FDA continues to ensure that participants identify their race (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or other Pacific Islander, or Caucasian) and ethnicity (Hispanic or Latino, or We recommend that you self-report if you are neither American nor Latino. ) and be allowed to designate a multiracial identity. In situations where collecting self-reported designations is not possible, the guidance recommends that research teams request this information from members of the participant’s family rather than assigning a race or ethnicity to the participant. . Newly added is the recommendation to use real-world data sources to obtain information such as medical records, provided the information contained in the records is verified by the participant.
The updated guidance also goes further into including racial and ethnic information on proposed product labels, suggesting listing baseline demographics of the study population in the Clinical Studies and Adverse Effects section. Masu.
We continue to await diversity action plan guidance from the FDA. This guidance is initially scheduled to be published in December 2023 and is required by the Food and Drug Omnibus Reporting Act of 2022 (FDORA).
Comments on this new draft version are due by April 29, 2024. If you have any questions about ensuring diversity in clinical research, or about clinical trial protocols more generally, please feel free to contact the author of this alert or Hogan’s Labels. A lawyer you work with regularly.
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