This report examines persistent underrepresentation of diverse populations in clinical trials and its implications for safety, efficacy, and equity. It highlights regulatory momentum, including FDA guidance, to improve inclusion across race, ethnicity, age, and socioeconomic groups. The analysis explores barriers such as restrictive eligibility criteria, site selection bias, and patient trust issues. It outlines practical strategies to improve diversity, including protocol design changes, community engagement, decentralized trial elements, and better use of real-world data. Advancing diversity is positioned as essential to generating representative evidence and improving patient outcomes.

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