Foley Attorneys Author Article on Finalized FDA Guidance for Decentralized Clinical Trials

Foley & Lardner LLP partners Monica Chmielewski and Kyle Faget and associate Jessa Boubker authored the Applied Clinical Trials article, “FDA Finalized Decentralized Clinical Trial Guidance.”

In the article, the authors provide an overview of decentralized clinical trials (DCTs), insights on the U.S. Food and Drug Administration’s final DCT guidance issued in September 2024, and explore the revisions made to the guidance for its final iteration, including to the sections on local health care providers, electronic systems, fully DCTs, DCT design, sponsor and investigator responsibilities, and laboratory tests.

“When conducting a DCT, it is imperative that compliance programs include mechanisms for frequent monitoring of updates to both federal and state laws and policies,” the authors conclude.