PUBLIC HEALTH, THERAPEUTICS
A post-market risk identification and analysis system for active surveillance of drugs and devices in a postmarket setting.
The program was developed by the FDA in 2008, and collates data from 26 collaborating institutions and about 125 million patients. It addresses covariates and exposures, validation of selected health outcomes, application of a distributed data set that conforms to a common data model, the development of statistical methods and analytical approaches to ensure validity and privacy.
Reference JAMA 2013; 309:1895-1896