The MRCT Center provided public comments on the FDA Draft Guidance document “Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry.”
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Ethics, Conduct, and Oversight
Research, Development, and Regulatory Roundtable
The August 1, 2019, R3 meeting addressed two topics: (1) Exporting from China for Research: Biospecimens, DNA and Data and (2) Legal and Ethical Issues in the Enrollment of a Company or Institution’s Own Employees and/or Students in Research Studies.
Global Regulatory Engagement
Real World Evidence
OptumLabs and MRCT Center announced that two academic institutions were awarded grants to support replication of established clinical trials through the use of electronic health record and claims data.
Focus Areas
News
Jun 25, 2019
OptumLabs and MRCT Center Award Grants for Replication of Drug Clinical Trials Using Real-World Data
[CAMBRIDGE, Mass., June 25, 2019]– OptumLabs and the MRCT Center announced that two academic institutions were awarded grants to support replication of established clinical trials through the use of electronic health record (EHR) and claims data, which could help improve clinical trial design and drug development.
May 03, 2019
Kick-off of Proactive Safety Surveillance Project
As the launch to the project, on May 3, 2019, the MRCT Center invited over 40 representatives from industry, academia, government, and patient advocacy groups to discuss a vision for aglobal, cooperative model of a more proactive, predictive safety surveillance system than exists today.
Apr 22, 2019
Launch of Proactive Safety Surveillance Initiative
Ensuring the safety of biological products, drugs, and devices in healthcare is the shared responsibility of regulatory, academic and industry-related stakeholders.
Resources
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Aug 08, 2019
Comments on Healthy People 2030 Updated Health Literacy Definition (Public Comments) -
Aug 02, 2019
Post-Submission Update: The Evolving Regulatory Landscape for Clinical Trials in India (Publication) -
Jul 30, 2019
Enhancing the Diversity of Clinical Trial Populations – Comments to FDA (Public Comments)
Events
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Oct 17, 2019
MRCT Center Bioethics CollaborativeDiscussion topic to be determined.
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Nov 07, 2019
Meeting of the Research, Development and Regulatory Roundtable (R3)Discussion topics to be determined.
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Dec 04, 2019
MRCT Center Annual MeetingThe MRCT Center Annual Meeting will be held in the morning, which will be followed by the meeting of the Executive and Steering Committee in the afternoon.
Our efforts have resulted in the implementation of best practices, greater transparency, and improved safety for research participants in clinical trials.