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.
Ethics, Conduct, and Oversight
Impact of GDPR on Clinical Research
The MRCT Center, in collaboration with Ropes and Gray, has led an effort to understand the key issues and implications of the GDPR on multi-regional clinical trials, clinical research, and public health.
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Global Regulatory Engagement
New Rules Released in India
On May 10, 2019, the MRCT Center, in collaboration with Ropes & Gray LLP, hosted a special presentation and discussion with the Drugs Controller General of India to discuss the final New Drugs and Clinical Trials Rules, 2019, that were released in March, 2019 by India’s Ministry of Health and Family Welfare. LINK TO MORE
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 topics: (1) Legal and Ethical Issues in the Enrollment of a Company or Institution’s Own Employees and/or Students in Research Studies, and (2) Exporting from China for Research: Biospecimens, DNA and Data
Discussion topic to be determined.
Discussion topics to be determined.