The New Sentinel Network — Improving the Evidence of Medical-Product Safety

TLDR

In 2007, Congress directed the FDA to create a new postmarketing surveillance system that will, by 2012, use electronic health data from 100 million people to prospectively monitor the safety of marketed medical products, complementing existing spontaneous adverse‑event reporting systems. The FDA announced the Sentinel Initiative in May 2008 to access the capabilities of multiple existing data systems, such as electronic health record systems and medical claims databases. The network of data systems is intended to detect signals of higher‑than‑expected rates of adverse outcomes and confirm those signals. No additional metadata provided.

Abstract

In 2007, Congress directed the Food and Drug Administration (FDA) to create a new postmarketing surveillance system that will, by 2012, be using electronic health data from 100 million people to prospectively monitor the safety of marketed medical products.1 This new system is intended to complement existing systems of "spontaneous" adverse-event reporting. In May 2008, the FDA announced the Sentinel Initiative, which would "access the capabilities of multiple, existing data systems (i.e., electronic health record systems, medical claims databases.)"2 The network of data systems is intended both to detect signals (i.e., higher-than-expected rates of adverse outcomes) and to confirm signals, . . .