Recent Projects
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
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.
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
Data Transparency
Return of Individual Results
The MRCT Center previously developed guidelines for the return of aggregate results to research study participants; this project will focus on returning individual results to study participants.
Data Transparency
Return of aggregate results
Providing Guidance Document and Toolkit for returning aggregate results to study participants; adapting to non-traditional medicine and non-Western culture and to returning individual results.
Data Transparency
Data Sharing & Transparency Initiative
Defining and realizing a vision of developing an international non-profit entity to promote, coordinate and facilitate clinical trial data sharing, access and transparency.
Focus Areas
News
May 09, 2017
Joint Task Force for Clinical Trial Competency Launches Website
The Joint Task Force for Clinical Trial Competency (JTF) has launched its new website: ClinicalTrialCompetency.org. This site hosts the Harmonized Core Competency Framework, as well as the news about the JTF’s latest initiatives, events, and resources.
Apr 04, 2017
Vivli Attains Non-Profit 501(c)3 Status
The MRCT Center is delighted to announce that Vivli has been approved as a 501(c)3 non-profit organization!
Apr 03, 2017
Data Authorship as an Incentive to Data Sharing
The MRCT Center, in collaboration with Harvard University and the American Association of Medical Colleges (AAMC), released a Sounding Board in the New England Journal of Medicine on the concept of data authorship, a designation and system of credit meant to recognize the efforts the data generators and data sharers.
Events
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Jun 18, 2017
Drug Information Association (DIA) 2017 Annual MeetingDr. Rebecca Li, Executive Director, MRCT Center, will be speaking on two topics: Post-Trial Access: Ensuring Patient Access Across the Development Spectrum and Data Sharing: 2017 and Beyond at the Drug Information Association (DIA) 2017 Annual Meeting.
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Jul 10, 2017
Fourth Clinical Regulatory Medical Writing ForumDr. Carmen Aldinger, Program Manager, MRCT Center, will be presenting at the Fourth Clinical Regulatory Medical Writing Forum.
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Jul 24, 2017
2017 Ethical Issues in Global Health Research Workshop at Harvard T.H. Chan School of Public HealthMRCT Center Faculty Co-Directors, Dr. Barbara Bierer and Mark Barnes, will be speaking at the 2017 Ethical Issues in Global Health Research Workshop at Harvard T.H. Chan School of Public Health (Sponsored by PRIM&R), which will take place July 24 – 27, 2017 in Boston, MA.