Reality Check For Real World Data: FDA’s Sentinel Network Enters “Production” Stage

FDA’s Sentinel drug safety surveillance network has completed an important transition, moving from “experimental” to “production stage” as a tool to help inform post-market safety decisions. Now the question is whether real-world data can be used in making efficacy decisions.

There’s no formal way to quantify it, but 2015 annual Sentinel Initiative stakeholder meeting was probably the least newsworthy of the seven held since the launch of the “real world” data monitoring system was mandated by the 2007 FDA Amendments Act.

The 2015 update conference did not include any major new functionality announcements, significant new milestones in the scope or capability of the program, or even much in the way of previously undisclosed outputs from the claims data safety analyses done as part of the project

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