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Post-Trial Responsibilities

Focus Area: Ethical Frameworks

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 subject’s participation has ended. This may include access to study medications and/or health care and infrastructure for study participants or entire communities for a specific time or lifelong.

Law, policy, and guidance in this area are vague, sometimes conflicting, and generally lacking in concrete solutions for questions regarding post-trial responsibilities. The issues are complex and demand thoughtful discourse to move the clinical trial enterprise towards meaningful solutions.

Current status: Published ethical framework; dissemination

Impact:

Bringing the clinical trial community towards a practical interpretation of the Declaration of Helsinki’s paragraph 34 that addresses post-trial access responsibilities

Objectives:

  • Develop a common terminology
  • Compile a case studies/scenarios portfolio
  • Develop an ethical framework for post-trial responsibilities
  • Create practical solutions for post-trial responsibilities
  • Develop training materials

Key milestones:

Project co-chairs: Luann Van Campen (Lilly), Barbara Bierer (MRCT Center)

  • September 18, 2014 – MRCT Center of Brigham and Women’s Hospital and Harvard convened a conference co-hosted by the Petrie-Flom Center for 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
    –  a range of practical issues
  • December 2014 – Objectives for workgroup finalized with Executive Committee input
  • February 2015 – Working group launched that addresses 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 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 Version 1.1 of Post Trial Responsibilities Toolkit released and Principles of Post-Trial Responsibilities Nov 2017 version released

Related external links:

2018 Edition of the International Compilation of Human Research Standards (including Declaration of Helsinki and Belmont Report)

Program Manager: Carmen Aldinger