Decentralized Clinical Trial Guidance Fulfills Promise, Underlies Digitization Of Healthcare

The FDA’s long-awaited guidance on decentralized clinical trials underscores the importance of digital health tech in clinical trials.

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The Food and Drug Administration released a guidance 2 May for Decentralized Clinical Trials for Drugs, Biological Products, and Devices that includes many guidelines for the proper training and execution of fully decentralized and hybrid clinical trials.

To qualify as a decentralized clinical trial (DCT), the clinical trial must conduct some or all of its trial-related activities...

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