Recent Projects
Global Regulatory
India Regulatory
Working closely with Indian leaders to determine tractable solutions to regulatory reform issues.
Training
APEC Pilot Center of Excellence
The MRCT Center received endorsement to become an Asia-Pacific Economic Cooperation (APEC) Pilot Center of Excellence (CoE) for Multi-Regional Clinical Trials (MRCTs) and Good Clinical Practice (GCP) inspection.
Ethical Frameworks
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
Training
Clinical Research Professional Competency
Promoting a set of harmonized competencies for training and qualification purposes of principal investigators.
Ethical Frameworks
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.
Data Transparency
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
Focus Areas
News
Mar 12, 2018
Global Regulatory Engagement: Mexico
Faculty Director Barbara Bierer, MD, traveled to Mexico City, Mexico, in February to learn more about the national preparedness for clinical trials.
Feb 05, 2018
MRCT Center Bioethics Collaborative published framework and toolkit on Expanded Access
The MRCT Center Bioethics Collaborative has published a framework and toolkit entitled Expanded Access to Investigational Products: A Practical Approach for Sponsors, Physicians, and Institutional Review Boards.
Dec 21, 2017
MRCT Center 2017 Impact Report Released
On December 6, 2017, at the MRCT Center Annual Meeting, we released the MRCT Center 2017 Impact Report, Harmonizing the Clinical Trial Ecosystem.
Resources
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Apr 20, 2018
2018-03-16 Public Comments: Regulation of New Drugs and Clinical Trials Rules: Comments and Rocommendations (LOGIN REQUIRED) -
Apr 19, 2018
2018-04-05 Other Resource: Essential Elements of Ethics User Statistics Dec 2017 -
Feb 27, 2018
2018-02-26 Bioethics Collaborative: Enabling Informed Selection of Clinical Trials – Meeting Summary Notes
Events
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Apr 10, 2018
APEC Pilot Center of Excellence Training on MRCT and GCPThis Asia-Pacific Economic Cooperation (APEC) Pilot Center of Excellence (CoE) training program on Multi-Regional Clinical Trials (MRCTs) and Good Clinical Practice (GCP) is a 3 1/2-day workshop — April 10-13, 2018 — hosted by the MRCT Center. It is specifically designed for regulators with responsibility for multi-regional clinical trials, drug review and approval, with priority […]
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Apr 21, 2018
AAHRPP 2018 Annual ConferenceBarbara Bierer, Faculty Director of the MRCT Center, will be presenting Participant Centered Research: Promoting the Disclosure of Individual and Aggregate Research Results at the Association for the Accreditation of Human Research Protection Programs (AAHRPP) 2018 Annual Conference in Denver, CO.
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Apr 24, 2018
MRCT Center Bioethics CollaborativeThe MRCT Center is planning the sixth meeting of the Bioethics Collaborative, which will be held on April 24th, 2018. The topic for discussion will be Axes of communication in Return of Individual Results to Research Participants.