US- FDA Draft Guidance on Decentralized Clinical Trials for Drugs, Biological Products, and Devices

The US FDA is announcing the draft guidance for industry entitled “Decentralized Clinical Trials for Drugs, Biological Products, and Devices.” Global Regulatory Policy and Intelligence will work with our internal SMEs and our trade organizations to consider comments.

This draft guidance provides recommendations for implementation of decentralized clinical trials (DCTs). A DCT refers to a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. DCTs have the potential to expand access to more diverse patient populations and improve trial efficiencies.

The draft guidance addresses:

• DCT Design
• Remote Clinical Trial Visits and Clinical Trial-Related Activities
• Digital Health Technologies (also see Regulatory Background below)
• Roles and Responsibilities
  • Sponsor, Investigator, and Delegation
• Informed Consent and Institutional Review Board Oversight
• Investigational Products in a DCT
  • Drugs and Biologics
  • Medical Devices
• Packaging and Shipping of Investigational Products
• Safety Monitoring Plan
• Software Used in Conducting DCTs (also see Regulatory Background below)

Sources:

Link to FDA draft guidance

Link to Federal Register notice

FDA_draft_guidance_Decentralized_Clinical_Trials_May_2023.pdf