In a newly released draft guidance, the US Food and Drug Administration (FDA) is proposing recommendations on conducting decentralized clinical trials (DCTs) of drugs, biologics and medical devices.
While the agency initially released draft guidance on trial decentralization during the early months of the COVID-19 pandemic, the new draft guidance was created to fulfill a requirement established in the Food and Drug Omnibus Reform Act (FDORA) to “issue or revise draft guidance that includes recommendations to clarify and advance the use of decentralized clinical studies to support the development of drugs and devices,” by late December 2023.
FDA defines a decentralized clinical trial as one where “some or all trial-related activities will occur at locations other than traditional clinical trial sites” such as performing a follow-up visit in a trial participant’s home over a telehealth appointment or conducting laboratory tests at a local health care facility. The goal of the draft guidance is to “advance medical product development and research” through the use of decentralized clinical trials with the aim of reducing participation barriers, increasing the “breadth and diversity” of trial participants and further drug development, the agency said…
