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.
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
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.
On December 7, 2016, at the MRCT Center Annual Meeting, we released several principles documents that summarize core principles of major MRCT Center projects:
On December 7, 2016, at the MRCT Center Annual Meeting, we released the MRCT Center 2016 Impact Report.
Transparency has been a special focus of the MRCT Center’s 2016 efforts. We introduced detailed plans for Vivli – an independent Center for Global Clinical Research Data – and we developed a principled framework for the return of individual research results to study participants. The 2016 Impact Report also highlights our work on harmonized core competencies for clinical research professionals, post-trial responsibilities, Bioethics Collaborative, and global regulatory efforts in India and China.
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.
