The MRCT Center engages diverse stakeholders to define emerging issues in global clinical trials and to create and implement ethical, actionable, and practical solutions.
Recent Projects
Data Transparency
Global Clinical Research Data
Vivli promotes clinical data sharing with enhanced data discovery methods, hosting data, and bridging to other established repositories.
Global Regulatory
China Global Regulatory Program
Providing scientific justification for when the utilization of a multi-regional clinical trial is sufficient to demonstrate safety and efficacy in a particular population.
Global Regulatory
India Regulatory
Working closely with Indian leaders to determine tractable solutions to regulatory reform issues.
Ethical Frameworks
Post-Trial Responsibilities
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.
Data Transparency
Return of aggregate results
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.
Data Transparency
Return of 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.
Focus Areas
News
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.
Sep 14, 2016
Register for October 19, 2016 Workshop: Core Competencies in Clinical Research
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.
Aug 01, 2016
Draft Principles for Return of Individual Results Available for Comments
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.
Resources
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Sep 14, 2016
2016-08-15 Public Comment: Summary of Clinical Trial Results for Laypersons – Comments to European Medicines Agency -
Aug 01, 2016
Report and Guidance Documents: Return of Individual Results: Principles and Approach -
Jul 22, 2016
2016-7-12 Presentation: Third Clinical Regulatory Medical Writing Forum(Login Required)
Events
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Dec 09, 2016
Paying Research Participants: Ethical and Regulatory ParametersThe 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.
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Dec 07, 2016
The MRCT Center 2016 Annual MeetingThis meeting for all MRCT Center stakeholders will present key deliverables of major projects achieved during 2016 and new projects planned for 2017.
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Dec 06, 2016
Individual Return of Results (IRR) Workgroup In-Person MeetingWe 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.
Our efforts have resulted in the implementation of best practices, greater transparency, and improved safety for research participants in clinical trials.