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Want Better Clinical Trial Design? Get Early Patient Input, Says FDA

 
• By Elizabeth Orr

A new guidance document from the US regulatory agency reasons that getting early feedback from patient advocates in the trial-design process could improve enrollment, trial completion and data quality.

Doctor working with diverse patients.
• Source: Prostock-studio / Alamy Stock Photo

Early feedback from patient advocates when designing a clinical trial could mean faster and more successful trials, the US Food and Drug Administration said in a 26 January guidance document.

The document, “Patient Engagement in the Design and Conduct of Medical Device Clinical Studies,” is part of a push by the FDA to encourage medtech sponsors to involve patients...

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