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Post-Trial Responsibilities

Focus Area: Ethics, Conduct, and Oversight

Post-Trial Responsibilities

When a clinical trial is completed, stakeholders in clinical research have certain ethical responsibilities to study participants. In 2015, the MRCT Center convened a multi-stakeholder group to develop guidance on Post-Trial Responsibilities (PTR) that is both ethically sound and practically applicable.

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. Released in December 2016, the MRCT Center Post-Trial Responsibilities (PTR) Framework is the culmination of this effort. The Framework aims to provide stakeholders with ethically sound and practically applicable guidance.

Objectives:

The 2015 Workgroup was convened to provide guidance on PTR that is both ethically sound and practically applicable.

The Workgroup objective was to develop a Framework for post-trial responsibilities that would include: (1) Guidance document, and (2) Toolkit (companion document) containing: (a) Decision-making tools, (b) Case studies, (c) Resources.

Key milestones:

  • 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.”

This project 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

Program Manager: 

  • Carmen Aldinger, PhD, MPH, PMP