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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. The workgroup developed principles, Guidance Document and Toolkit which were released in 2017.

Current status: Dissemination and Communication

Impact: Trial sponsors, trial sites, clinical trial investigators and their study teams, and healthcare providers collaboratively understand their responsibilities to study participants at the end of trial with regard to investigational products and required medical care. A practical interpretation of the Declaration of Helsinki’s paragraph 34 guides that understanding.

Deliverables:

Key milestones:

  • 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 conference brought together key stakeholders in industry, government, academia, and non-profit sector and centered on:
    – perspectives on post-trial responsibilities
    – lessons learned from efforts to implement post-trial access policies
    – successful case studies for post-trial access to investigational drugs
    – framing the issues and expectations on the issue
    –  suggesting a range of practical issues
  • December 2014 – Objectives for workgroup finalized with Executive Committee input
  • February 2015 – Working group launched to address key priorities identified at the September 18, 2014 conference.
  • March 2015: Working group agreed on definitions
  • December 2015: Draft Post-Trial Responsibilities Framework presented at MRCT Center Annual Meeting
  • December 2016: Version 1.0 of Post-Trial Responsibilities Framework Guidance Document released and Principles of Post-Trial Responsibilities 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 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

Related external links:

International Compilation of Human Research Standards (including Declaration of Helsinki and Belmont Report)

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