The MRCT Center
The MRCT Center is a research and policy center focused on the conduct, oversight, ethics, and regulatory environment of multi-national clinical research. We are associated with two of the world’s most respected names in healthcare and academia: Brigham and Women’s Hospital and Harvard University.
We function as an independent convening group to bring together collaborative multidisciplinary teams to identify expert stakeholders from industry, academia, advocacy groups, nonprofit organizations, and regulatory agencies to address critical issues in the conduct and oversight of clinical trials. We engage patients and participants throughout all stages of our work.
Our efforts have resulted in the implementation of improved clinical research practices, greater transparency, clearer communication, increased diversity and inclusion, and improved safety for research participants.
Our Vision
Improve the integrity, safety, and rigor of global clinical trials
Our Mission
Engage diverse stakeholders to define emerging issues in global clinical trials and to create and implement ethical, actionable, and practical solutions.
History
Founding – The “MRCT Project” was initiated in 2008. An initial plan was first reported in 2009 at a summit meeting held at Harvard University with a group of diverse stakeholders. The output culminated in recommendations that led to the establishment of the Multi-Regional Clinical Trials Center (MRCT Center) under the joint leadership of Barbara E. Bierer, MD, and Mark Barnes, JD. The report served as the blueprint for the Center’s first initiatives. The mission of the MRCT Center was to focus on the design, conduct, and oversight of multi-regional clinical trials, emphasizing those issues involving multinational and emerging economies.
Expansion – Starting in 2010, additional industry, non-profit and academic stakeholders joined the MRCT Center as members of the Executive and Steering Committee, forming a diverse stakeholder community of like-minded organizations to address the common challenges associated with globalization of clinical trials. The MRCT Center was administratively located at the Harvard Global Health Institute, under the Provost’s Office at Harvard University, with offices in Harvard Square. Numerous projects and workstreams were launched, including Post-Trial Access to Medicines, Return of Results, and Core Competencies in Clinical Research Professionals. In 2013, the MRCT Center launched a workstream to address data sharing and transparency that, among other issues, envisioned a platform to enable access to clinical trial data with the capacity to combine data sets. In 2017, the MRCT Center launched this platform as Vivli, a Center for Global Data Sharing, that was incorporated as a separate 501(c)(3) entity. We have worked in China, India, Mexico, Algeria, Indonesia, and the continent of Africa to provide in-person or virtual training.
Today – The MRCT Center is located at the Brigham and Women’s Hospital and is administratively associated with the Division of Global Health Equity at the Brigham and Women’s Hospital. The Center leads numerous projects that seek to identify the emerging challenges in global clinical trials and deliver ethical, actionable, and practical solutions for the global clinical trial enterprise. Our Executive and Steering Committees are actively engaged in the development of our ongoing work. We are actively engaged in regulatory and ethics systems capacity-building and coordination across the African continent. Through multiple capacity building and training assets, including the Joint Taskforce for Clinical Trial Competency, the Clinical Research Glossary, guidance for patient data return, frameworks for post-trial, continued access, oversight of decentralized elements in clinical trials, and using artificial intelligence in clinical research, we seek to increase the skill and capacity of the clinical trial workforce, as well as the participant-facing resources they have to clearly communicate research. As the official ICH training partner for the E6(R3) Guideline for Good Clinical Practice, we are training clinical research stakeholders around the world.
Access to Resources and Tools – Since 2009, the MRCT Center’s efforts have resulted in the implementation of best practices, greater transparency, and improved safety for research participants. The majority of our resources and tools are freely and openly available. Our collaborative community includes approximately 10,000 people from 100 countries.
