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Leveraging Real-World Data to Estimate Race and Ethnicity Representation in Clinical Trial Design

Leveraging Real-World Data to Estimate Race and Ethnicity Representation in Clinical Trial Design

Pages 10 Pages

This paper says clinical trials often under‑represent racial and ethnic groups, so the FDA urges inclusive criteria that reflect target populations. IQVIA proposes defining the condition, exploring government, literature and healthcare data and synthesizing evidence to set realistic diversity goals. The authors emphasise that no single data source suffices; multi‑source real‑world data is essential for inclusive trial design.

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