Biologics

Decentralized Clinical Trial Recommendations

FDA has published a draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices, with recommendations for sponsors, investigators, and other stakeholders on the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and medical devices. The document defines a decentralized clinical trial as one in which some or all of the trial-related activities occur at locations other than traditional clinical trial sites. In fully decentralized trials, FDA says, all activities take place at locations other than traditional trial sites.

In an associated news release, the agency says that in reducing barriers to participation in trials, it expects that DCTs “will increase the breadth and diversity of participants in clinical trials and improve accessibility for those with rare diseases or mobility challenges. We anticipate that this approach will facilitate the development of drugs including in areas of medical need, resulting in more treatment options and improved patient outcomes.”

The guidance covers recommendations on these topics:

DCT design considerations;
conduct of remote clinical trial visits and clinical trial-related activities in a DCT;
use of digital health technologies to remotely acquire data in a DCT;
roles and responsibilities of the sponsor and investigator in a DCT;
obtaining informed consent and institutional review board oversight of the informed consent process in a DCT;
determination of the appropriateness of investigational products for use in a DCT;
packaging and shipping of investigational products in a DCT; and
safety monitoring of DCT trial participants.

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