In November 2017, the MRCT Center published the Post-Trial Responsibilities: Continued Access to Investigational Medicines Guidance Document and Toolkit. This framework outlined a case-based, principled, stakeholder approach to evaluate and guide the ethical responsibilities related to providing continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial.
Over the past 5 years, sponsors and investigators have utilized the MRCT Center guidance to create their own internal PTR policies. While the ethical principles and main consensus points remain valid, the application of the ethical principles and implementation of consensus points continue to challenge clinical research stakeholders and study participants. It is therefore timely to revisit and update the framework. This meeting served as a launch for revisiting the MRCT Center’s 2017 Guidance Document. Starting in January 2023, the Center will be convening a monthly task force to (1) define the current issues associated with continued access to investigational drugs and maintenance of implantable devices after trial completion and (2) identify practical and actionable resources and tools needed by stakeholders.
Released on: October 2022
Developed by: MRCT Center Bioethics Collaborative
See Meeting Summary