US FDA Proposed Draft Guidance on DCT for Drugs, Biological Products, and Devices

The U.S. Food and Drug Administration (FDA) proposed draft guidance that contains its recommendations for implementing decentralized clinical trials (DCTs) for drugs, biological products, and devices. It covers the design of DCT, remote clinical trial visits and clinical trial-related activities, digital health technologies, roles and responsibilities, informed consent and institutional review board, an investigational product, safety monitoring, and software used in DCTs.

 

Activities in a clinical trial may be conducted at locations other than the traditional clinical trial sites and FDA recognizes that these decentralized trials have the potential to expand access to more diverse patient populations and improve trial efficiencies.

 

Sponsors, investigators, and other stakeholders involved in decentralized clinical trials should consider these recommendations in conducting these trials.

 

The final deadline for comments is 1 August 2023.