|Project Title||Statistical Approaches to Group Sequential Monitoring of Postmarket Safety Surveillance Data: Current State of the Art for use in the Mini-Sentinel Pilot|
Thursday, January 19, 2012
This article describes the current statistical methodology available for active postmarket surveillance of pre-specified safety outcomes using a prospective incident user concurrent control cohort design with existing electronic healthcare data. Four sequential monitoring statistical methods are presented along with hypothetical applications.
- Vaccines, Blood & Biologics
- Devices and Radiologic Health