The FDA's Sentinel Initiative is growing up, but its potential is just starting to be realized.
Over the past eight years, the network of FDA adverse event claims has matured from what's been known as Mini-Sentinel and expanded beyond drug surveillance to include vaccines, blood and biologic products, and medical devices.
In the process, Sentinel has become a routine part of the agency's postmarket vigilance, the FDA's Janet Woodcock said Wednesday at the eighth annual Sentinel Initiative Workshop. Now the FDA is looking at adding data types and moving Sentinel into new uses, such as effectiveness studies.
The goal is to make the data housed in the Sentinel network a national resource that's available to other researchers, Woodcock said. To do that, the FDA is developing a "distributed data network" through partnerships and collaborations with data sources at university medical research centers, hospital systems, insurance