Post-Trial Responsibilities

Post-Trial Responsibilities

Post-trial responsibilities refer to a wide range of possibilities for providing continued access to study interventions (and potentially other care) once a trial is over, or a participant’s time on the trial has completed. Post-trial responsibilities may include access to study medications and/or health care and infrastructure for study participants or their communities for a given amount of time. Law, policy, and guidance in this area are vague and/or conflicting, and often lacking in concrete approaches regarding post-trial responsibilities. The issues are complex and demand thoughtful discourse to move the clinical trial enterprise towards meaningful solutions.

In 2015, the MRCT Center convened a multi-stakeholder group to interpret the Declaration of Helsinki’s paragraph 34 and to develop guidance on the practical implementation of post-trial responsibilities. In November 2017, the MRCT Center published the Post-Trial Responsibilities: Continued Access to Investigational Medicines Guidance Document and Toolkit. This original 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. These resources have been used to develop policies and procedures at many global research organizations.

In 2022, the MRCT Center initiated a taskforce to update and add to the original resources. Utilization identified that the ethical principles and main consensus points remained valid, however additional work was needed to advise on the practical application of the work. Our current work includes a revised set of principles with an associated analysis to assist in implementation, and a framework that outlines stakeholder responsibilities for continued access to investigational products. The current work was discussed at the MRCT Center annual meeting in December 2023, which included a panel of PTR subject matter experts. Proceedings of this meeting are available.

The MRCT Center’s future work in this area includes challenges associated with post-trial, continued access for medical devices, investigator-initiated research, and research in lower and middle-income countries.

New and updated tools produced from this project will be published below and will offer guidance and address challenges that the clinical trial enterprise encounters through the application of the ethical principles and implementation of consensus points from the first version of the PTR Framework.

Project Resources