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New FDA Draft Guidance Shows That the Time for Decentralized Clinical Trials is Now

On May 1, 2023, the U.S. Food and Drug Administration (FDA) released an updated Draft Guidance on decentralized trials, providing recommendations for clinical trial sponsors as they incorporate virtual elements into their programs.

The FDA recognizes that decentralized clinical trials offer significant benefits, but they also require careful planning and coordination in the lead-up to and throughout trial execution. 

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