FDA issues final guidance on conducting clinical trials with decentralized elements

FDA issues final guidance on conducting clinical trials with decentralized elements on 17^th Sept 2024

The FDA finalized recommendations for implementing decentralized trial elements like telehealth, in-home visits, local HCP involvement, and digital tools outside traditional sites. The guidance highlights benefit such as improved participant convenience, reduced caregiver burden, better access for rare and mobility-limited populations, and enhanced recruitment and retention representativeness.

Key highlights include:

• DCT design and conduct: Protocols should include clear instructions to limit variability, specify visit types (site-based, remote, or participant’s choice), and consider training or remote supervision for at-home assessments to reduce variability.
• Remote visits and activities: Telehealth should align with the investigational product and patient group; local HCPs may handle routine tasks within their scope, but research-specific tasks requiring protocol/IP expertise must be performed by trained trial staff.
• Digital health technologies: DHTs can securely transmit data remotely; sponsors should ensure usability and availability for all participants to promote equitable participation.
• Roles and responsibilities: Sponsors oversee contracted local HCP networks and monitor decentralized adaptations; investigators handle participant rights, safety, and delegated tasks.
• Investigators should assign a location for FDA inspections; remote consent is allowed but obtaining consent remains the investigator's responsibility, not for local HCPs.
• Investigational products: Consider safety and complexity when allowing outside site use; high-risk or complex IPs may need in-person oversight, while well-characterized IPs or suitable home-use devices can be used with qualified oversight.
• Packaging and shipping involve ensuring IP integrity/stability, tracking receipt, managing unused products, and supervising supply with investigators.

Safety monitoring: Plans should reflect decentralized operations, define how local HCPs report concerns, and instruct participants on responding to and reporting adverse events and where to seek medical help