Conducting Clinical Trials with Decentralized Elements: FDA Update

Date: September 18, 2024
Category: US Regulations
Description: Today, the U.S. Food and Drug Administration issued a final guidance, “Conducting Clinical Trials with Decentralised Elements.” providing recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralised elements in clinical trials.

In this guidance, a decentralised clinical trial (DCT) refers to a clinical trial that includes decentralised 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 modernise clinical trial design and conduct to improve efficiency and reduce burden on participants and on those conducting the trial.