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‘Resilient’ Trials: US FDA Wants To Apply COVID Lessons In Trial Design

 
• By Michael McCaughan

The US FDA is not expecting sponsors to launch ‘pandemic-proof’ trials, but does want to see advance planning so that adaptations can be implemented for unexpected emergencies with ‘less burnout.’

resilient clinical trials
• Source: Shutterstock

The US Food & Drug Administration wants clinical trial designs to anticipate potential changes that might be necessary in the event of a public health emergency or natural disaster.

During an October workshop on mitigating clinical trial disruptions, Center for Biologics Evaluation & Research Deputy Director Celia Witten captured a key message from the discussion: “The goal is not...

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