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Virtual | Virtual

Event Title
Decentralized Clinical Trials (DCT) Draft Guidance
June 20, 2023

Date:
June 20, 2023
Time:
3:00 PM - 4:00 PM ET

Topic & Presentations

Speakers

Decentralized Clinical Trials (DCT) Draft Guidance  

 

Intro - Decentralized Clinical Trials for Drugs, Biological Products, and Devices

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

Overview of the DCT Draft Guidance

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

Q&A Discussion Panel

Same as above

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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landscape and clarify the Agency’s recommendations on the conduct of DCTs, the FDA will provide an overview of the draft guidance titled Decentralized Clinical Trials for Drugs, Biological Products, and Devices.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

INTENDED AUDIENCE

  • Entities (e.g. sponsors, contract research organizations) designing clinical investigations which incorporate decentralized elements or who submit INDs/IDEs
  • Developers of DCT software or digital health technologies
  • Clinical trial personnel or other healthcare professionals involved in clinical investigations using decentralized elements
  • Patients (or caregivers of patients) participating in DCTs
  • Regulators involved in the use of DCT data to support marketing applications

FDA RESOURCES

Event Materials

Title File Type/Size
Decentralized Clinical Trials (DCT) Draft Guidance_June_30_2023.pdf pdf (318.37 KB)
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