The MRCT Center submitted public comments on the definition of health literacy in Healthy People 2030 to the Secretary of Health and Human Services.
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Ethics, Conduct, and Oversight
Representation of Diverse Populations
The MRCT Center submitted public comments on “Enhancing the Diversity of Clinical Trial Populations” to the US FDA on July 30, 2019.
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.
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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Nov 15, 2019
Diversity in Clinical Trials In-Person Workgroup Meeting
Our efforts have resulted in the implementation of best practices, greater transparency, and improved safety for research participants in clinical trials.