1. Pink Sheet

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

The US Food and Drug Administration has been lauded for the regulatory flexibility it has shown drug sponsors trying to navigate and mitigate the effects of the COVID-19 pandemic on ongoing and new clinical trials.

Agency guidance, issued quickly and regularly updated, has widely opened the door to decentralized trials with remote collection of efficacy and safety data, as well as alternative ways of distributing investigational study drug

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