Lexology October 24, 2024
On Sept. 18, 2024, the U.S. Food & Drug Administration (FDA) issued a final guidance document titled “Conducting Clinical Trials With Decentralized Elements, Guidance for Industry, Investigators, and Other Interested Parties”(CTDE guidance). The final guidance, which builds upon a prior draft guidance document issued in May 2023, provides valuable insight into a host of issues implicated by decentralized clinical trials (DCTs). It also reflects the FDA’s continued support for well designed and implemented DCTs and underscores the benefits that trials with decentralized elements can provide to trial participants, industry members and healthcare consumers. This article provides an overview of the guidance and discusses key takeaways for industry members, investors and other stakeholders.
Decentralized Clinical Trials
While DCTs are not new...
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