Decentralized Clinical Trials (DCT) Draft Guidance
June 20, 2023
- June 20, 2023
- 3:00 PM - 4:00 PM ET
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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landscape and clarify the Agency’s recommendations on the conduct of DCTs, the FDA will provide an overview of the draft guidance titled Decentralized Clinical Trials for Drugs, Biological Products, and Devices.
- 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
Leonard Sacks, MBBCh
Clinical Methodologies | Office of Medical Policy (OMP) | CDER | FDA
Ryan Robinson, MD
Clinical Methodologies | OMP | CDER | FDA
- 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
- Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, Guidance for Industry, Investigators, and Other Stakeholders
- DHTs for Drug Development Mailbox
Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.
This webinar has been:
- pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
- pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
- pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration
- approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
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