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.
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.
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.
Ensuring the safety of biological products, drugs, and devices in healthcare is the shared responsibility of regulatory, academic and industry-related stakeholders.
Discussion topic: Real-World Evidence & Pragmatic Clinical Trials
Discussion topic: to be decided
Discussion topic: Artificial Intelligence in Clinical Trials