MRCT Focus Areas

Overview

The MRCT Center has five 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 advisors, to develop country-specific and culturally-relevant solutions and to work 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 of representatives from industry, not-for-profit organizations, patients and patient advocacy groups, and academia to create practical resources for the ethical design and conduct 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 results to study participants as well as development of a global infrastructure for sharing of participant-level clinical trial data.

The MRCT Center offers training courses, in conjunction with a local partner, 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 world. It is critical that trials are conducted ethically and overseen by experienced and competent professionals and at well-qualified sites that have the necessary resources and appropriate human research protections.