FDA Free Webinar on Decentralized Clinical Trials (DCT) Draft Guidance

FDA’s CDER Small Business and Industry Assistance (SBIA) group is hosting a webinar on June 20, 2023 @ 3:00 PM - 4:00 PM ET.  The webinar is FREE and more info and link to the registration is here.

ABOUT THIS WEBINAR

The FDA sees important potential benefits and value in DCTs. Advances in clinical care using electronic communications and information technology to interact with trial participants in different locations (i.e., telehealth) allow for fewer in-person visits to clinical trial sites and facilitate decentralization. In addition, digital health technologies have expanded the types of trial-related data that can be obtained remotely from trial participants. By enabling remote participation, DCTs may enhance convenience for trial participants, reduce the burden on caregivers, expand access to more diverse patient populations, improve trial efficiencies, and facilitate research on rare diseases and diseases affecting populations with limited mobility. As part of the FDA’s efforts to be responsive to the rapidly evolving clinical trial landscape and clarify the Agency’s recommendations on the conduct of DCTs, the FDA will provide an overview of the draft guidance titled Decentralized Clinical Trials for Drugs, Biological Products, and Devices.

TOPICS COVERED

• 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
• Roles and responsibilities of the sponsor and investigators in a DCT
• Obtaining informed consent and institutional review board oversight of the informed consent 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
• Software used to support the conduct of a DCT

FDA 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