On December 7, 2016, at the MRCT Center Annual Meeting, we released Version 1.0 of the MRCT Center Post-Trial Responsibilities Framework: Continued Access to Investigational Medicines – Guidance Document.
A multi-stakeholder workgroup, convened by the MRCT Center, developed this document, which outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial.