Advancing Decentralized Clinical Trials for Drugs, Biological Products, and Devices: FDA's Latest Steps.

The FDA has released a new draft guidance to support the use of decentralized clinical trials (DCTs) for drugs, biologics, and devices. DCTs allow some or all trial-related activities to take place at trial participants’ homes or other convenient locations, increasing the breadth and diversity of participants in clinical trials and improving accessibility for those with rare diseases or mobility challenges. The guidance covers recommendations on design considerations, remote clinical trial visits, use of digital health technologies, roles and responsibilities of sponsors and investigators, obtaining informed consent, and safety monitoring of trial participants. The FDA expects that DCTs will play an important role in addressing public health needs and improving patient outcomes.