FDA Issues New Draft Guidance on DCTs

The FDA announced new draft guidance that builds on its recommendations from March 2022 for clinical trial conduct in response to the COVID-19 public health emergency. This new draft guidance provides recommendations sponsors, investigators and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biologics and devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites.

FDA Commissioner Robert M. Califf, MD, said in a press release, “As we seek to improve our evidence generation system, decentralized clinical trials may enhance convenience for trial participants, reduce the burden on caregivers, expand access to more diverse populations, improve trial efficiencies, and facilitate research on rare diseases and diseases affecting populations with limited mobility.”

Reference: FDA Takes Additional Steps to Advance Decentralized Clinical Trials. FDA News Release, May 2, 2023.