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.
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.
In 2014, the MRCT Center convened a multi-stakeholder workgroup to develop a Guidance Document and Toolkit for returning aggregate results to trial participants. The Guidance Document and Toolkit were released in March 2015 and, since then, modified in response to questions, suggestions, and continued progress in the field.
The MRCT Center spearheaded a Perspective in the New England Journal of Medicine that spells out the need and requirements for a global, neutral platform for sharing clinical trial data.
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.
Oct 19, 2016
Core Competencies for Clinical Research Professionals: Evolution of a Harmonized Framework and Real World Applications
This workshop will include discussion of real world applications, future revisions and future objectives for core competencies framework for clinical researchers.