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Representation of Diverse Populations homepage format

The MRCT Center provided public comments on the FDA Draft Guidance document “Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry.”

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.

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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.

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Focus Areas

Our efforts have resulted in the implementation of best practices, greater transparency, and improved safety for research participants in clinical trials.