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. The platform is designed for use by researchers and sponsors from academia, industry and the non-profit sectors.
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.
In 2014, the MRCT Center convened a multi-stakeholder workgroup to develop a Guidance Document and Toolkit for returning aggregate results to trial participants. The Guidance Document and Toolkit were released in March 2015 and, since then, modified in response to questions, suggestions, and continued progress in the field.
The MRCT Center spearheaded a Perspective in the New England Journal of Medicine that spells out the need and requirements for a global, neutral platform for sharing clinical trial data.
The MRCT Center is delighted to announce the launch of our new External Advisory Board which will have its inaugural meeting on June 29, 2016, at Harvard Faculty Club.
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.
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.