Recent Projects
Transparency
Harmonized Governance Tools for Data Sharing
Develop harmonized governance tools for data sharing, enhance data transparency and collaboration, reduce administrative barriers, shorten the time to new discovery
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.
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
Resources
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Oct 17, 2018
Return of Individual Results to Participants – From Theory to Practice (Presentation – Login Required) -
Sep 24, 2018
Truth in Advertising: Disclosure of Participant Payment in Research Recruitment Materials (Publication) -
Sep 24, 2018
Assessment of a Shortened Informed Consent Form for Pediatric Research: A Pilot Study (Publication)
Events
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Nov 08, 2018
Research, Development, and Regulatory Roundtable (R3) on Expanded Access vs. Right to Try: Practical, Legal, and Regulatory Considerations.We will discuss the advantages and drawbacks of the two pathways by which patients may now request access to investigational therapies, considering the perspectives of both pharmaceutical companies and of largely academic healthcare facilities.
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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.
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Dec 05, 2018
MRCT Center Annual MeetingThe MRCT Center Annual Meeting (open to interested stakeholders) will be held in the morning (8:00 AM -1:00 PM), and will include updates on current projects and a keynote speaker.