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Feb 05, 2018

MRCT Center Bioethics Collaborative published framework and toolkit on Expanded Access

The MRCT Center Bioethics Collaborative has published a framework and toolkit entitled Expanded Access to Investigational Products: A Practical Approach for Sponsors, Physicians, and Institutional Review Boards.

This document, which is tailored to sponsors, treating physicians, and Institutional Review Boards/ Research Ethics Committees, includes a set of principles, considerations, and practical tools. It addresses expanded access to investigational products for seriously ill patients who are unable to participate in a clinical study and for whom no equivalent or satisfactory treatment options are available.