The US Food and Drug Administration’s (FDA) final guidance on decentralized clinical trials (DCTs) addresses some key issues from the draft guidance raised by clinical experts and industry groups, including providing more information on requirements to keep a task log of healthcare providers (HCPs), physical inspection requirements, and clarifying challenges around data variability in DCTs.
The agency defines DCTs as occurring at non-traditional clinical trial locations, such as a participant’s home or in a local healthcare facility. These local providers and clinical laboratory facilities may be used in a trial with decentralized elements to manage trial participants, and use digital health technologies and telehealth to obtain data. FDA noted that trials with decentralized are subject to the same regulatory requirements as those with non-decentralized elements…
