Drug sponsors should consider why a clinical trial requires a diverse patient population when determining whether US Food and Drug Administration diversity requirements must be met with US-based participants, FDA’s Oncology Center of Excellence Director Richard Pazdur said.
Key Takeaways
- Richard Pazdur gave three reasons why the FDA desires clinical trial diversity, adding that some offer more flexibility to use ex-US patients.
Pazdur jumped up from the audience at a 16 October FDA-American Cancer Society Symposium on benchmarks for diversity in oncology clinical trials to answer an AstraZeneca representative’s question...
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