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.

Objectives

Define and analyze the current critical issues of post-trial responsibilities associated with:
- Continued access to investigational drugs/biologics after trial completion
- Maintenance or explant of implanted devices after trial completion.
Discuss and develop practical and actionable resources to assist in the planning and implementation of post-trial, continued access of Investigator-initiated research.
Explore and understand challenges associated with continued access to investigational products in resource-limited settings.
Review and improve prior recommendations and tools, as indicated.
Identify new practical and actionable resources and tools needed by stakeholders.

Key Milestones

October 2022: MRCT Center hosted a Bioethics Collaborative – Post-Trial Responsibilities: Continued Access to Investigational Medicines and Devices
June 2022: Post-Trial Responsibilities Project Update initiated
December 2017: Version 1.2 of Post-Trial Responsibilities Guidance Document and Version 1.1 of Post-Trial Responsibilities Toolkit released and Principles of Post-Trial Responsibilities Nov 2017 version released
June 2017: Version 1.1 of Post-Trial Responsibilities Framework Guidance Document and Version 1.0 of Toolkit released, Version 1.1 of Principles of Post-Trial Responsibilities released
December 2016: Version 1.0 of Post-Trial Responsibilities Framework Guidance Document released and Principles of Post-Trial Responsibilities released
December 2015: Draft Post-Trial Responsibilities Framework presented at MRCT Center Annual Meeting
March 2015: Working group agreed on definitions
February 2015: Working group launched to address key priorities identified at the September 18, 2014 conference
September 18, 2014: MRCT Center convened a conference co-hosted by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, “Post-Trial Access Responsibilities: Ethics and Implementation.”

Project Leadership & Staff

The taskforce for the project update (2022- current) includes:

Sarah White, MPH. Executive Director, MRCT Center
Karla Childers, BA, MSJ, MSBE. Co-Lead, Johnson & Johnson
Barbara Bierer, MD. Faculty Director, MRCT Center
Kayleigh To, MPH. Project Manager, MRCT Center

The original project (2015-2017) was co-chaired by:

Luann Van Campen, PhD, MA. Senior Advisor and Head of Bioethics, Eli Lilly & Company
Barbara E. Bierer, MD. Faculty Director, MRCT Center
Carmen Aldinger, PhD, MPH, PMP. Project Manager, MRCT Center