FDA Issues Draft Guidance on Decentralized Clinical Trials

Last week the U.S. Food and Drug Administration released a new?draft guidance?that provides recommendations for sponsors, investigators and other stakeholders regarding decentralized clinical trials (DCTs) to advance medical research.

FDA Commissioner Robert M. Califf, M.D., acknowledged that the benefits of decentralized clinical trials, which were accelerated with advancements in digital health technologies and the COVID-19 pandemic-when in-person visits were limited or unavailable for many trial participants.

Decentralized clinical trials can 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, Dr. Califf adds.

The new draft guidance, which builds on guidance from 2020, covers recommendations on:

• design considerations for a DCT;
• conduct of remote clinical trial visits and clinical trial-related activities in a DCT;
• use of digital health technologies to remotely acquire data in a DCT;
• roles and responsibilities of the sponsor and investigators in a DCT;
• obtaining informed consent (IC) and institutional review board oversight of the IC process in a DCT;
• determination of the appropriateness of investigational products for use in a DCT;
• packaging and shipping of investigational products in a DCT;
• safety monitoring of trial participants in a DCT; and
• software used to support DCTs.

Continue reading for a few of our key takeaways.