FDA Gives Guidance for Decentralized Clinical Trials for Drugs, Devices

FDA released a new draft guidance that provides recommendations aimed at sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. This specific guidance refers to a DCT as a clinical trial where some or all the trial-related activities occur at locations other than traditional clinical trial sites.

According to the draft guidance document, in a fully decentralized clinical trial, all activities take place at locations other than traditional trial sites. Further, these trial-related activities may take place at the homes of trial participants or in local health care facilities that are convenient for trial participants. In terms of a hybrid DCT, some trial activities involve in-person visits by trial participants to traditional clinical trial sites, while other activities are located at places other than traditional clinical trial sites, like a participants’ homes.

This new guidance provides suggestions that are related to FDA’s requirements for investigations of medicinal products when applied to DCTs and fulfills the requirement set forth in section 3606(a)(1) of the FDORA.

Source: FDA