Sentinel Will Start Small, FDA Tells IoM; Are Expectations Too Big?

Agency plans to launch two "mini-Sentinel" pilots, one using private data sources and one tying together Medicare, VA and DoD data. More importantly, agency is focusing on using Sentinel for signal strengthening-that is, to test signals generated via existing means, not generate new ones. That position seems to have broad support from thought leaders in epidemiology, but may not match stakeholder expectations for Sentinel

FDA plans to launch two "mini-Sentinel" pilot projects as the next steps towards building the active surveillance capability called for under the FDA Amendments Act of 2007, Sentinel Initiative Scientific Lead Judith Racoosin told a Sept. 2 Institute of Medicine meeting focused on the drug safety system post-FDAAA.

Those projects—one testing FDA's proposed model for a distributed data network model using private data sources, the other combining government-only...

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