May 15, 2015
Post-Trial Responsibilities Defined
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.