In September 2024 FDA issued its final guidance, "Conducting Clinical Trials With Decentralized Elements", replacing the May 2023 draft. It applies to drugs, biologics and devices, and covers trials where some or all activities take place at locations other than traditional sites.
Key expectations
- The investigator remains responsible for trial-related activities wherever they occur, including those performed by local healthcare providers.
- A data management plan should describe the data flow from each source, including digital health technologies, and how data integrity is maintained.
- Investigational product shipping, administration and accountability must be controlled when products go directly to participants.
- Sponsors must consider how decentralised elements affect safety monitoring and adverse event reporting.
Practical implications
Decentralised elements reduce participant burden but increase the number of vendors and data sources a study manager must oversee. Our trial management and trial monitoring teams have built oversight plans for hybrid studies that satisfy both this guidance and the E6(R3) direction.