In a draft guidance released May 2, the U.S. FDA provided recommendations for sponsors, investigators and other stakeholders for implementation of decentralized clinical trials (DCTs) to advance research in medical devices, drugs and biologics. This week’s announcement responds to the Food and Drug Omnibus Reform Act, signed into law late last year, which required the agency to “issue or revise draft guidance that includes recommendations to clarify and advance the use of decentralized clinical studies to support the development of drugs and devices.”