The MRCT Center engages diverse stakeholders to define emerging issues in global clinical trials and to create and implement ethical, actionable, and practical solutions.
Working closely with Indian leaders to determine tractable solutions to regulatory reform issues.
Defining and realizing a vision of developing an international non-profit entity to promote, coordinate and facilitate clinical trial data sharing, access and transparency.
Providing scientific justification for when the utilization of a multi-regional clinical trial is sufficient to demonstrate safety and efficacy in a particular population.
Providing training to ensure those tasked with adjudicating causality are up-to-date on latest methods in causality determination and have practical scenarios.
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 2015 Awards for Excellence in Human Research Protection were announced on December 28th by Dr. Peter G. Goldschmidt, President and Founder of Health Improvement Institute, “The award program recognizes submissions that our judging panel determines have demonstrated excellence in promoting the well-being of human research participants.”
Workshop in Beijing.
May 03, 2016
The New World of Transparency for Clinical Trial Results Presentation at MAGI 2016 Conference
Barbara Bierer, Faculty Co-Director, MRCT Center, and Carmen Aldinger, Program Manager for MRCT, will be presenting on Tuesday May 3 titled The New World of Transparency for Clinical Trial Results. The MAGI’s Clinical Research Conference will be taking place this year at the Westin Copley Place in Boston from May 1st to 4th.
During this 2-day, March 21-22, 2016, invitation-only meeting, the MRCT Center and collaborators will present plans to launch a new not-for-profit organization charged with directing, implementing and governing a global clinical trial data-sharing platform.