Recent Projects
Ethical Frameworks
MRCT Bioethics Collaborative
A forum to encourage the discussion of bioethical issues among stakeholders in global clinical trials for drug and device development
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.
Global Regulatory
India Regulatory
Working closely with Indian leaders to determine tractable solutions to regulatory reform issues.
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.
Focus Areas
News
Apr 25, 2018
Successful APEC Center of Excellence Training Workshop on Multi-Regional Clinical Trials (MRCT) and Good Clinical Practice (GCP)
In April 2018, the MRCT Center held a 3 1/2-day training workshop at the Harvard Faculty Club focused on Multi-Regional Clinical Trials (MRCT) and Good Clinical Practice (GCP) as an APEC (Asia-Pacific Economic Cooperation) Pilot Center of Excellence (CoE), and specifically on ICH-E17 and ICH-E6(R2).
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.
Resources
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Apr 19, 2018
2018-04-05 Other Resource: Essential Elements of Ethics User Statistics Dec 2017 -
Mar 16, 2018
2018-03-16 Public Comments: Regulation of New Drugs and Clinical Trials Rules: Comments and Rocommendations (LOGIN REQUIRED) -
Feb 27, 2018
2018-02-26 Bioethics Collaborative: Enabling Informed Selection of Clinical Trials – Meeting Summary Notes
Events
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Jul 19, 2018
Vivli Platform LaunchThe official launch of the Vivli platform will take place at the National Academies in Washington D.C. on July 19, 2018.
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Jun 04, 2018
BIO 2018 conferenceBarbara Bierer, MD, MRCT Faculty Director will participate in a panel discussion on APEC regulatory convergence at the BIO 2018 conference in Boston, MA.
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May 16, 2018
Ethical and IRB Approaches for a Successful Embedded A vs. B Pragmatic TrialBarbara Bierer, MD, MRCT Faculty Director, will deliver a lecture on Ethical and IRB Approaches for a Successful Embedded A vs. B Pragmatic Trial at the Bethesda Marriott Pooks Hill in Bethesda, MD on May 16, 2018 from 8am-4:30pm