11:39 AM
Jan 09, 2019
 |  BC Extra  |  Politics & Policy

FDA to expand Sentinel in five-year plan

FDA announced Wednesday a five-year plan to expand the analysis capabilities of its Sentinel safety monitoring platform and leverage the platform to accelerate the use of real-world evidence.

Sentinel allows FDA to run queries that look for postmarketing safety signals across data sets from U.S. insurance companies and healthcare providers. The database was built to incorporate primarily insurance claims data, electronic health records and registry data.

"This strategy envisions a more robust Sentinel System which operates as a transformative national resource," FDA’s Scott Gottlieb and Gerald Dal Pan said in a joint statement. "The data and scientific resources will function as a multi-purpose center for evidence generation with the potential to be used by more stakeholders and inform all aspects of healthcare decision-making."

Gottlieb is FDA commissioner, while Dal Pan is director of CDER’s Office of Surveillance and Epidemiology.

By 2023, FDA aims to enhance Sentinel's foundational data, infrastructure, operations and technology; augment its safety analysis capabilities using advances in data science and signal detection; use the platform to accelerate access to and broaden the use of real-world data for real-world evidence; broaden Sentinel's user base; and disseminate knowledge and advance regulatory science to encourage innovation.

The agency will hold a public workshop in April to discuss the new Sentinel strategy.

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