Info Sheet
Developed on: April 5, 2018
Developed by: The Global Health Network
Focus Area: Clinical Trials & Research
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.
MRCT Center 2017 Impact Report Released
On December 6, 2017, at the MRCT Center Annual Meeting, we released the MRCT Center 2017 Impact Report, Harmonizing the Clinical Trial Ecosystem.
The MRCT Center continued to promote transparency and responsible sharing of clinical trial data. Vivli, the data sharing platform, was incorporated and awarded non-profit, tax-exempt status. The MRCT Center is developing fit-for-purpose prototype templates that will address governance issues in data sharing. Our training efforts have grown significantly this year. We hosted the first pilot training on ICH E6(R2), convening regulators and investigators from 14 countries. The MRCT Center Return of Results Workgroup completed the framework guidance and toolkit, which addresses the complexity of sharing genetic data. We have launched several new projects in 2017, two of which are related to the utility and limitations of real world evidence in regulatory decision-making. On our horizon is a new project to address the lack of diversity in clinical trials.
Return of Individual Results to Participants (Principles)
Principles
Published on: December 7, 2017
Presented at: MRCT Center Annual Meeting
Developed by: MRCT Center Return of Individual Results Workgroup
MRCT Center Return of Individual Results to Participants Toolkit Version 1.2
Tools
Released on: December 6, 2017
Developed by: MRCT Center Return of Individual Results Workgroup
Post-Trial Responsibilities Framework Released
We have released the MRCT Center Post-Trial Responsibilities Framework: Continued Access to Investigational Medicines. This framework consists of two parts: a Guidance Document (Version 1.1) and a Toolkit (Version 1.0) .
This framework 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. An international multi-stakeholder workgroup, convened by the MRCT Center, developed this framework.
The foundation of this framework is summarized in 12 principles
Using Data for the Public Good: Sharing Aggregate and Individual Results
Presentation
Presented by: Barbara Bierer
Presented on: February 10, 2017
Presented to: Portal Ethics and Health Policy Seminar: Returning Results to Research Participants, Harvard Law School, Cambridge, MA
New Publication by MRCT Center Faculty Co-Directors
In January 2017, MRCT Center Faculty Co-Directors, Dr. Barbara Bierer and Mark Barnes, JD, co-authored with Abram Barth and David Peloquin an article entitled, “HHS Finalizes Comprehensive Revisions to the Common Rule” published in Bloomberg BNA Life Sciences Law & Industry Report.
Continue reading “New Publication by MRCT Center Faculty Co-Directors”CBI Clinical Data Disclosure and Transparency Conference
Presentation
Presented by: Rebecca Li
Presented on: January 31, 2017
Presented at: CBI Clinical Data Disclosure and Transparency Conference, Philadelphia, PA
Principles Papers Released
On December 7, 2016, at the MRCT Center Annual Meeting, we released several principles documents that summarize core principles of major MRCT Center projects:
Return of Aggregate Results to Participants Principles
Principles of Post-Trial Responsibilities: Continued Access to an Investigational Medicine
These short principles documents provide a handy summary of major concepts of larger MRCT Center publications and efforts.