A Conference on Post-Trial Responsibilities: Ethics and Implementation 

Wasserstein Hall, Milstein East AB, 1585 Massachusetts Ave.,Cambridge, MA 02138, USA

The MRCT Center at Harvard and the Petrie-Flom Center at Harvard Law School are proud to co-host A Conference on Post-Trial Responsibilities: Ethics and Implementation. 

Introduction / Background:

The term “post-trial access” is used broadly to connote 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.  For the purposes of this conference, we will focus discussions on the following:

1. Continued access to study intervention(s) and/or other care for people who were enrolled in the clinical trial and were benefitting (whether between the end of the trial and product approval or indefinitely)
2. Provision of the study intervention(s) and/or other care to people who were enrolled in the clinical trial but did not get the intervention and would like to try it (whether between the end of the trial and product approval or indefinitely)
3. Provision of the study intervention, other care, or other resources to the community in which the trial was conducted

Law, policy, and guidance 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.  Areas that currently lack clarity include:

1. How are recommendations regarding post-trial responsibilities influenced by the trial phase and/or prior experience with the intervention?
2. What types of interventions or resources should be included within post-trial responsibilities?  Do recommendations include ancillary care, treatment of side effects and adverse events, etc.?
3. What is a reasonable duration for post-trial responsibilities to extend?
4. What is the mission and purpose of various stakeholders (sponsors, governments, investigators, etc.) in the conduct of clinical research and how do these roles intersect with post-trial access responsibilities?  In particular, how do government and sponsor responsibilities relate to each other?  Do recommendations change when research is sponsored by non-profit entities?

This conference will bring together diverse stakeholders to address some of these questions.

Objectives:

• To discuss implications of international guidance on post-trial responsibilities for clinical research sponsors, governments, investigators, and other stakeholders
• To articulate and understand the range of perspectives on post-trial responsibilities
• To draw lessons from successful and unsuccessful attempts to implement post-trial access policies
• To discuss potential scenarios and practical solutions for post-trial responsibilities that may inform policy in this important area moving forward
• To identify key priorities for a Post-Trial Responsibilities Working Group to be launched by the Multi-Regional Clinical Trials Center at Harvard

Session I: Setting the Stage (Moderator: I. Glenn Cohen)

Objective: To introduce current ethical and regulatory approaches, as well as key controversies.

Session II: Important Perspectives (Moderator: Barbara Bierer)

Objective: To convey the range of stakeholder perspectives and current approaches from sponsors, regulators, patients, and investigators, and identify areas of convergence and divergence

Session III: Lessons Learned: Case Studies on Implementing Post-Trial Responsibilities (Moderator: Holly Fernandez Lynch, Petrie-Flom Center)

Objective: To better understand real world experiences implementing post-trial responsibilities, including both successes and failures, and to more clearly articulate and assess the complexities involved.

Session IV: Working Toward Solutions: Group Discussion of Hypothetical Post-Trial Scenarios (Moderator: Mark Barnes)

For more information on the agenda, please click here.

For more information on the scenarios, please click here.