Collection of Race and Ethnicity Data in Clinical Studies – Standardizing the Sociocultural Construct of Our Society
The FDA’s updated guidance on race and ethnicity data collection in clinical trials calls for using OMB-standardized categories to ensure accurate demographic representation. Sponsors must create a Diversity Action Plan, with mandatory implementation for new studies within 180 days after final guidance. Participants will self-report race and ethnicity, with the option to identify as multiracial and confirm their information against medical records.