Secondary Uses of Sentinel

FDA’s new drug safety surveillance system is up and running, though the implications for safety oversight are only just beginning to be felt. But the conversation is already under way about what else Sentinel can do—and the answers may be very important to the future of drug regulation.

FDA’s Sentinel post-marketing surveillance system relies on what is known as "secondary use” of health records. That is, the system analyzes data created for one purpose (to process insurance claims) for a completely different reason (to answer research questions about outcomes of therapy, and especially adverse events).

The application of health claims data to regulatory purposes is, in fact, the key accomplishment of the Sentinel project to...

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