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FDA Issues Guidance on Implementing Decentralized Elements in Clinical Trials

Today, the U.S. Food and Drug Administration issued a final guidance, “Conducting Clinical Trials with Decentralized Elements,” providing recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials. 

In this guidance, a decentralized clinical trial (DCT) refers to a clinical trial that includes decentralized elements where trial-related activities occur at locations other than traditional clinical trial sites including telehealth visits, in-home visits with remote trial personnel, or visits with local health care providers. By enabling remote participation, DCTs may enhance convenience for trial participants, reduce the burden on caregivers, expand access to more diverse patient populations, improve trial efficiencies, and facilitate research on rare diseases and diseases affecting populations with limited mobility.  

This guidance is a part of a multifaceted FDA effort to help modernize clinical trial design and conduct to improve efficiency and reduce burden on participants and on those conducting the trial. 

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