US FDA Will Leverage Current Clinical Trial Data In Deciding On Post-COVID Flexibilities

 
• By Sue Sutter

Oncology Center of Excellence’s Paul Kluetz says agency intends to explore the effects of decentralization, remote assessments and other approaches adopted mid-stream on safety evaluations, missing data and endpoint variability.

Yellow flag waving on the beach in the breeze against a blurred blue sky.
US FDA wants clinical datasets flagged for that period of time when a decentralized model was in place. • Source: Shutterstock

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