Conducting Clinical Trials With Decentralized Elements

The FDA has issued final Level 1 guidance (Docket Number: FDA-2022-D-2870) from the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Oncology Center of Excellence, offering recommendations for sponsors, investigators, and stakeholders on incorporating decentralized elements in clinical trials.

This guidance emphasizes the advantages of conducting trial-related activities remotely, making participation more convenient for trial subjects. Decentralized elements may include telehealth consultations, in-home visits by remote trial personnel, or interactions with local healthcare providers. By allowing clinical trials to occur outside traditional sites, this approach aims to enhance participant engagement and streamline data collection.

With this new guidance, stakeholders are encouraged to explore decentralized clinical trials to improve accessibility and efficiency in clinical research.