The MRCT Center engages diverse stakeholders to define emerging issues in global clinical trials and to create and implement ethical, actionable, and practical solutions.
Vivli promotes clinical data sharing with enhanced data discovery methods, hosting data, and bridging to other established repositories.
Providing scientific justification for when the utilization of a multi-regional clinical trial is sufficient to demonstrate safety and efficacy in a particular population.
Working closely with Indian leaders to determine tractable solutions to regulatory reform issues.
Developing an ethical framework and toolkit for addressing post-trial responsibilities related to access to investigational product, access to medical care, and access to infrastructure.
Providing Guidance Document and Toolkit for returning aggregate results to study participants; adapting to non-traditional medicine and non-Western culture and to returning individual results.
The MRCT Center previously developed guidelines for the return of aggregate results to research study participants; this project will focus on returning individual results to study participants.
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.
Dec 08, 2016
MRCT Center 2016 Impact Report Released
On December 7, 2016, at the MRCT Center Annual Meeting, we released the MRCT Center 2016 Impact Report.
On October 19, 2016, 52 participants from academia, industry, non-profit organizations, professional associations and regulatory agencies gathered at Harvard Faculty Club for a workshop on “Core Competencies in Clinical Research: Real World Applications, Convergence and Evolution of Framework.”
Dr. Barbara Bierer, Faculty Co-Director, MRCT Center, will be a panelist participating in the Portal Ethics and Health Policy Seminar: Returning Results to Research Participants. This seminar will discuss the complex questions regarding policies on how results should be returned to patients involved in research studies.
MRCT Center Executive Director, Rebecca Li, will give innovative insights on how to “Navigate through MRCT Center’s Interoperable Platform for Data Sharing in Clinical Trials.”
The Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School, with The MRCT Center, will be sponsoring the Paying Research Participants: Ethical and Regulatory Parameters symposium on December 9, 2016.