The MRCT Center has four primary areas of focus that address pressing issues in multi-regional clinical trials.
The MRCT Center engages global regulatory leaders to promote convergence between local regulations and internationally accepted best practices. Our approach involves working with our stakeholders to identify emerging issues in global clinical trial practice and, in our role as independent advisors, to develop country-specific and culturally-relevant solutions, working with local partners to strive towards regulatory convergence.
The MRCT Center develops guidance, resources, and tools that promote safe and ethical clinical trials. We perform our work through convening representatives from academia, industry, not-for-profit organizations, patients and patient advocacy groups, and others to create practical resources for the ethical design, conduct and oversight of multi-regional clinical trials.
The MRCT Center examines barriers to clinical trial data sharing and develops practical, actionable solutions driven through multi-stakeholder participation. Our projects include returning aggregate and individual results to study participants, the development of a global infrastructure for sharing of participant-level clinical trial data (now Vivli), progress towards establishment of academic credit for data generators who share their data, and comprehensive model governance templates.
The MRCT Center offers a variety of training resources to principal investigators, ethics committee members, regulators and other clinical trial staff to build capacity with a focus on sites and personnel in the emerging economies. When trainings are offered in country, a local partner is always involved. It is critical that trials are conducted ethically and overseen by experienced and competent professionals, at well-qualified sites that have the necessary resources, and with the highest standards of protections for clinical trial participants.