Principles
Date: November 13, 2024
The Principles of Post-Trial Responsibilities: Continued Access to an Investigational Product are 12 principles that guide the shared responsibilities and actions to provide continued access to an investigational product at the conclusion of a patient’s participation in a clinical trial. The principles, accompanied by an analysis, should be read as a whole.
The principles are designed to be used in coordination with the Framework of Responsibilities (Medicines) and (Devices – coming in 2025), a framework of milestones, specific scenarios, and considerations that organizations can utilize to make equitable and fair decisions related to continued access to an investigational product.