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Post-Trial Responsibilities

Focus Area: Ethics, Conduct, and Oversight

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 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 Post-Trial Responsibilities guidance. 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. Therefore, in the fall of 2022, the MRCT Center started to revisit and update the framework.

New and updated tools produced from this project revision 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 the current critical issues associated with:
    1. Post-trial responsibilities
    2. Continued access to investigational drugs, and
    3. Maintenance of implanted devices after trial completion
  • 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.”

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

  • Sarah White, Executive Director, MRCT Center
  • Barbara Bierer, Faculty Director, MRCT Center
  • Kayleigh To, Project Manager, MRCT Center

Taskforce to be determined late 2022.

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

Project Manager:  Carmen Aldinger, PhD, MPH, PMP