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Woodcock Open To Endpoint Flexibility For Rare Diseases

 
• By Sarah Karlin-Smith

Acting US FDA Commissioner also touts master protocols’ potential for rare diseases, arguing patient-funded foundations could overcome sponsor hesitancy to collaborate with potential rivals.

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Combinations of multiple endpoints may be possible for rare-disease trials, Woodcock says.

Acting US Food and Drug Administration Commissioner Janet Woodcock expressed openness to sponsors using combinations of endpoints in clinical trials of rare disease drugs to better power studies.

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