FDA Releases Updated Draft Guidance On Decentralized Clinical Trials

In May, the U.S. Food and Drug Administration released a revision to preliminary recommendations concerning the development and execution of decentralized clinical trials (DCTs). The draft document fulfills Section 3606(a) of the Food and Drug Omnibus Reform Act, requiring the FDA to issue guidance on DCTs by December 29, 2023.

As outlined by the revised draft guidance, regulators have defined DCTs as trials in which certain or all trial-related activities take place outside of conventional trial settings. Furthermore, the draft identifies scenarios that may gain advantages from a decentralized research approach and offers recommendations to sponsors to uphold patient safety and data security.

Take a closer look at draft guidance, notably the handling of remote trial visits, the use of digital health technologies, institutional review board oversight, and more.