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.
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.
The MRCT Center 2016 Annual Meeting was held on December 7, 2016 and was attended by about 80 stakeholders, including representatives from academia, governmental agencies, institutional review boards, the pharmaceutical industry, and non-profit organizations.
The MRCT Center is pleased to announce that we have received endorsement to become a Pilot Center of Excellence (CoE) at the Asia-Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee (RHSC) SOM1 Meeting in Nha Trang, Vietnam.
Apr 03, 2017
New England Journal of Medicine Webinar: Aligning Incentives for Sharing Clinical Trial Data
Dr. Barbara Bierer, Faculty Co-Director, MRCT Center, will be a panelist participating in the New England Journal of Medicine Webinar: Aligning Incentives for Sharing Clinical Trial Data. This webinar on April 3 and 4 will foster a conversation among a variety of stakeholders in clinical trials, to discuss responsible data sharing and help determine sustainable solutions. […]
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. This webinar, which will take place on April 18, 10:00-11:30am and April 20, 3:30-5:00pm, will review current efforts and regulations in returning aggregate and individual results to study participants […]
Dr. Barbara Bierer, Faculty Co-Director, MRCT Center, will be presenting at the Society for Clinical Trials and International Clinical Trials Methodology Conference. For those working in clinical trials, this conference on May 8-10 offers one of the largest international platforms for discussion and collaboration. Dr. Bierer will be speaking in the third workshop on Tuesday, […]