Revolutionizing Clinical Trials with Decentralization.
The FDA has released draft guidance for sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. DCTs refer to clinical trials where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. The guidance provides recommendations for conducting fully decentralized clinical trials or hybrid DCTs, where some activities involve in-person visits by trial participants to traditional clinical trial sites, and other activities are conducted at locations other than traditional clinical trial sites.