Lexology October 21, 2024
On September 18, 2024, the U.S. Food and Drug Administration (FDA) issued final Guidance on recommendations for conducting decentralized clinical trials (DCTs) for drugs, devices or biological products. Instead of using traditional clinical trial sites, DCTs hold some or all trial activities remotely at locations convenient for trial participants by, for example, using telehealth appointments, outsourcing visits to local healthcare providers, or conducting laboratory tests at outside facilities.
FDA published the DCT Guidance in response to the passage of Section 3606(a) of the Consolidated Appropriations Act, which directed FDA to clarify how to operate DCTs and how such trials can increase trial participant diversity.
Many clinical trials, according to FDA, are already DCTs. FDA believes that including remote components has...
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