FDA Draft Guidance on Decentralized Clinical Trials 🧪

FDA provides an overview of the draft guidance titled Decentralized Clinical Trials for Drugs, Biological Products, and Devices. FDA experts Discuss topics such as design of 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, and roles and responsibilities of the sponsor and investigators in a DCT.

Timestamps

00:56 – Intro - Decentralized Clinical Trials for Drugs, Biological Products, and Devices

04:25 – Overview of the DCT Draft Guidance

30:35 – Q&A Discussion Panel

Speakers:

Leonard Sacks, MBBCh
Associate Director
Clinical Methodologies
Office of Medical Policy (OMP) | CDER | FDA

Ryan Robinson, MD
Medical Officer
Clinical Methodologies
OMP | CDER | FDA

Panelists:

Same as above

Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/decentralized-clinical-trials-dct-draft-guidance-06202023

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