Racial and Ethnic Diversity in Clinical Trials – FDA Guidance and How it Impacts Patient Recruitment in Clinical Trials
The FDA issued a draft guidance in 2022, urging industry sponsors to develop a Race and Ethnicity Diversity Plan for clinical trial participation, focusing on underrepresented groups. The guidance, while not legally binding, reflects an industry shift towards diverse patient recruitment, with specific requirements for data collection and enrollment strategies for diverse participants.
January 2, 2024
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