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US FDA’s Pazdur On When And Why US Patients Must Satisfy Trial Diversity Requirements

 
• By Sarah Karlin-Smith

Flexibility on the geographic location of clinical trial participants will depend on the underlying reasons the FDA wants diversity in the study, the agency’s Oncology Center of Excellence Director said.

earth surrounded by lots of arms in different colors reaching toward it.
The FDA's Richard Pazdur offered advice on meeting diversity requirements with global trials during a 16 October meeting. (Shutterstock)

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.

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