Recent Projects
Global Regulatory Engagement
Real World Evidence
Investigating the reliability of evidence from retrospective database studies of medical claims and electronic medical records by engaging diverse stakeholders to determine study design
Capacity Building
Good Clinical Practice (GCP) and Multi-Regional Clinical Trials (MRCT) Training
Improving regulatory capacity to provide a unified standard for conducting clinical trials.
Ethics, Conduct, and Oversight
Protocol Ethics
Providing systematic guidance for protocol writers to address ethical considerations in planned clinical trials and for ethics committee members to ensure study protocols have adequately addressed ethical issues
Ethics, Conduct, and Oversight
Post-Trial Responsibilities
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.
Global Regulatory Engagement
India Regulatory
Working closely with Indian leaders to determine tractable solutions to regulatory reform issues.
Ethics, Conduct, and Oversight
Health Literacy in Clinical Research
A collaborative project to support the development of tools and resources that more fully incorporate health literacy concepts into clinical research materials created for participants.
Focus Areas
News
Aug 28, 2018
Introducing the Research, Development, and Regulatory Roundtable (R3) of Ropes & Gray LLP and the MRCT Center
The R3 provides a periodic, non-partisan forum wherein policymakers, regulators, legal counsel, and academicians may present, discuss, and deliberate cutting-edge issues in drug and device development, regulatory oversight of clinical trials, and human subjects research.
Jul 30, 2018
Recent Publications
Dr. Barbara Bierer, MRCT Center Faculty Director, co-authored Development of a Plain-Language Library of Educational Resources for Research Participants, recently published in the Journal of Clinical and Translational Research.
Jun 22, 2018
Bioethics Collaborative Meeting Summary Notes Released
The MRCT Center Bioethics Collaborative is delighted to share a very brief summary of the April 24, 2018 discussion related to Return of Individual Results to Research Participants and Axes of Communication. Read the summary here
Events
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Sep 21, 2018
Harvard Medical School Center for Bioethics’ September Research Ethics ConsortiumDr. Barbara E. Bierer, MRCT Center Faculty Director, will be a commentator at the Harvard Medical School Center for Bioethics’ September Research Ethics Consortium.
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Oct 24, 2018
Seventh Meeting of the MRCT Bioethics CollaborativeThe MRCT Center is planning the seventh meeting of the Bioethics Collaborative, which will be held on October 24th, 2018. The topic for discussion will be Withdrawal of a Marketed Product: Ethical, Practical, and Regulatory Considerations.
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Nov 15, 2018
PRIM&R’s 2018 Advancing Ethical Research ConferenceSarah White, MRCT Center Executive Director, will co-present (1) ClinicalTrials.gov: How Academic Institutions Can Respond to New Clinical Trial Disclosure Requirements and (2) Ideas and Practices for for Compliance and Auditing of Single IRB Studies at the Advancing Ethical Research Conference.