The MRCT Center engages diverse stakeholders to define emerging issues in global clinical trials and to create and implement ethical, actionable, and practical solutions.
Identifying, recruiting and training leaders from emerging regions who have expertise in medicine or statistics and experience in clinical trials, to equip them to serve on Data Monitoring Committees (DMCs).
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 received endorsement to become an Asia-Pacific Economic Cooperation (APEC) Pilot Center of Excellence (CoE) for Multi-Regional Clinical Trials (MRCTs) and Good Clinical Practice (GCP) inspection.
Promoting a set of harmonized competencies for training and qualification purposes of principal investigators.
Providing training of the decisions made throughout the drug and vaccine development process .
Providing training to understand how to effectively monitor for risks of medicines after approval.
Apr 04, 2017
Vivli Attains Non-Profit 501(c)3 Status
The MRCT Center is delighted to announce that Vivli has been approved as a 501(c)3 non-profit organization!
Apr 03, 2017
Data Authorship as an Incentive to Data Sharing
The MRCT Center, in collaboration with Harvard University and the American Association of Medical Colleges (AAMC), released a Sounding Board in the New England Journal of Medicine on the concept of data authorship, a designation and system of credit meant to recognize the efforts the data generators and data sharers.
Mar 24, 2017
Return of Aggregate Results Version 3.0 Released
The MRCT Center updated the MRCT Center Return of Aggregate Results Guidance Document and the MRCT Center Return of Aggregate Results Toolkit to incorporate and reflect the EU Guidelines on Summaries of Clinical Trial Results for Laypersons.
Apr 18, 2017
AAHRPP Webinar: Data Transparency and Respect for Persons: Sharing Aggregate and Individual Results with Research Participants
Dr. Barbara Bierer, Faculty Co-Director, MRCT Center, will be presenting in the Association for the Accreditation of Human Research Protection Programs (AAHRPP)’s 2017 Educational Webinar Series.
Dr. Barbara Bierer, Faculty Co-Director, MRCT Center, will be presenting at the Society for Clinical Trials and International Clinical Trials Methodology Conference.
Dr. Rebecca Li, Executive Director, MRCT Center, will be speaking on two topics: Post-Trial Access: Ensuring Patient Access Across the Development Spectrum and Data Sharing: 2017 and Beyond at the Drug Information Association (DIA) 2017 Annual Meeting.