Article

Incorporating Real-World Clinico-Genomic Insights to Inform Diversity Enrollment Targets in Oncology Trials

2024-04-19

Abstract excerpt

The passage of the US Food and Drug Administration (FDA) Omnibus Reform Act of 2022 underscores a national commitment to enhancing diversity in clinical trials. This commitment recognizes not only the ethical imperative of inclusivity but also the practical necessity to ensure the safety and efficacy of medications across all demographic groups. Particularly for Phase 3 and pivotal clinical trials, the FDA has iss...

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Literature Corpus work: 88ca8058-1e52-56e6-b082-ba1a280713af
DOI: 10.1101/2024.04.17.24305991

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