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.
Sep 14, 2016
Register for the MRCT Center Annual Meeting
The MRCT Center will hold its 2016 Annual Meeting on December 7, 2016, at Harvard Faculty Club’s Loeb House in Cambridge, Massachusetts.
The MRCT Center will host a workshop to discuss the evolution of a harmonized framework of core competencies for clinical research professionals and its application to real world experiences. Fifteen real life case studies applying the core competencies by industry, professional societies and academia in the US and global settings will be presented.
A multi-stakeholder work group, led by the MRCT Center, discussed over the last six months issues relevant to returning individual results of clinical trials to participants. We have drafted an initial set of eight principles that are directly relevant to the return of individual results and that are open for comment.
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.
Key themes of the meeting are: Discussion of the impact of the newly released ICH E17 Guidelines, and Data Transparency (sharing data with researchers and individual participants). This meeting is for all MRCT Center stakeholders.
We will host an in-person meeting of the IRR workgroup that has been convening since December 2015. This workgroup will finalize the draft of the Recommendations Document and Toolkit for returning individual results.