Understanding The New FDA Guidance On Decentralized Clinical Trials

The FDA’s 2024 guidance on decentralized clinical trials (DCTs) provides crucial recommendations for sponsors, investigators, and stakeholders integrating decentralized elements into clinical research. While not legally enforced, this guidance validates long-standing DCT practices, reinforcing their role in advancing drug and device development. This article explores the evolution of the guidance, highlighting key updates on sponsor responsibilities, data variability, inspections, and trial design.

The guidance acknowledges DCT benefits as well as distinguishing between fully decentralized and hybrid trial models, emphasizing a tailored approach based on investigational product complexity. Additionally, recommendations cover remote visits, digital health technologies, informed consent, and investigational product distribution. Whether you are a sponsor, investigator, or industry professional, this article delivers valuable guidance on navigating the evolving landscape of decentralized clinical research.