Statistical Approaches to Group Sequential Monitoring of Postmarket Safety Surveillance Data: Current State of the Art for use in the Mini-Sentinel Pilot

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
Date
Thursday, January 19, 2012
Location
Description

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.

Corresponding Author

A. J. Cook, Biostatistics Unit, Group Health Research Institute, 1730 Minor Avenue, Suite 1600, Seattle, WA 98101, USA. Email: cook.aj@ghc.org

Authors

Andrea J. Cook PhD; Ram C. Tiwari PhD; Robert D. Wellman MS; Susan R. Heckbert MD, PhD; Lingling Li, PhD; Patrick Heagerty PhD; Tracey Marsh MS; Jennifer C. Nelson PhD

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