In collaboration with Ropes & Gray LLP, the MRCT Center hosted a closed, one-day roundtable on Monday, July 30th.
This meeting covered the Application of the General Data Protection Regulation (GDPR) to Research: Legal, Practical and Strategic Implications. Convening over 110 representatives from academia, industry, and government, this roundtable explored the impact of the EU GDPR on human subjects research by highlighting the challenges posed by the GDPR to clinical research, biobanking and data banking, and big data research.
Mr. Mark Barnes, MRCT Center Faculty Co-director, co-authored Will Consent be Disfavored as a Bases for Processing Personal Data in Clinical Research Under EU Data Protection Law? recently published by Bloomberg Law. The article may be accessed by navigating to his bio and scrolling to the bottom of the page for his publications.
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.
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.
