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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.

Working Group Agreed-upon DEFINITIONS (As of March 2015)

“Post-trial responsibilities”
The term “post-trial responsibilities” is sometimes used to denote “post-trial access to an investigational drug”, but it should be interpreted to include more expansive responsibilities after the conclusion of a clinical trial. Post-trial responsibilities may include, for instance, transitioning research participants (patients) to other venues for obtaining clinical care and treatment, provision of counseling, and/or the obligation (if any) to provide benefits to the community and country in which the clinical trials were conducted.
 “Post-trial access to an Investigational Drug”
The term “post-trial access” has varied meanings, often resulting in confusion and misunderstanding. For the purpose of this workgroup, post-trial access will be used to mean “continued access to an investigational drug for participants who have participated in the clinical trial”. In contrast to expanded access that is directed to individuals who cannot participate in a clinical trial, post-trial access refers to individuals who did participate in a clinical trial. It is commonly the sponsor’s provision of investigational product for clinical trial participants after their trial participation ends. Continued access options may include open-label trial extensions, rollover studies, separate protocols, or protocol amendments.

Current status: Finalizing 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

Related external links:

2017 Edition of the International Compilation of Human Research Standards (including Declaration of Helsinki and Belmont Report)

Program Manager: Carmen Aldinger