The Post-Trial Responsibilities Working Group, sponsored by the MRCT Center at Harvard, was launched in February 2015 and is a multi-stakeholder group with 55 members from academia, industry, non-profit organizations, government, and patient organizations. Twelve countries are represented.
The purpose of this working group is to develop an ethical framework for post-trial responsibilities, including case studies and practical guidance, which can then be used to conduct training sessions.
As an initial step, the working group focused on a single consensus definition of post-trial responsibilities and related terminology – post-trial access to an investigational drug, and expanded access of an investigational drug. These definitions will serve as the platform upon which the framework will be based. The consensus definitions as of March 2015 can be accessed below.
There are multiple ethical challenges for conducting multi-regional clinical trials in developing countries, such as whether patients in developing countries are free to participate in research if access to essential medicines is tied to research, and how informed consent can be assessed and risks and benefits understood when the element of choice is so different.
The MRCT Center has developed an Essential Ethics Toolkit and E-Learning course that address these and other issues and is committed to transparency, dissemination, and harmonization.
MRCT Center at Harvard collaboratively with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School hosted a one-day open conference on post-trial responsibilities on September 18, 2014, at the Harvard Law School.
The objectives of the conference were to discuss implications of international guidance on post-trial responsibilities for clinical research, to articulate and understand the range of perspectives on post-trial responsibilities, to draw lessons from successful and unsuccessful attempts to implement post-trial policies, and to discuss potential scenarios and practical solutions for post-trial responsibilities that may inform policy in this important area moving forward.
MRCT Center at Harvard and the Petrie-Flom Center at Harvard Law School 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:
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)
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)
Provision of the study intervention, other care, or other resources to the community in which the trial was conducted
Harvard Law School, Wasserstein Hall, Millstein East, Cambridge, MA
The objectives of the conference were to discuss implications of international guidance on post-trial responsibilities for clinical research, to articulate and understand the range of perspectives on post-trial responsibilities, to draw lessons from successful and unsuccessful attempts to implement post-trial policies, and to discuss potential scenarios and practical solutions for post-trial responsibilities that may inform policy in this important area moving forward.
