Decentralized Clinical Trials Could Affect Validity Of Non-Inferiority Finding, US FDA Says

 
• By Brenda Sandburg

Draft guidance notes that data obtained from a decentralized clinical trial may be less precise than that from a site-based trial, creating challenges in calculating a non-inferiority margin. FDA specifies what should be included in DCT data management, trial monitoring and safety monitoring plans.

Decentralized clinical trial
FDA issues draft guidance on decentralized clinical trials • Source: Shutterstock

The US Food and Drug Administration’s long-awaited draft guidance on decentralized clinical trials points out one challenge in using this approach: calculating whether the investigational drug is noninferior to an active control treatment.

“The variability and precision of the data obtained in a DCT may differ from the data in a traditional site-based...

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