TabsDetailsBasic DetailsDate: Thursday, January 19, 2012Type: PublicationDescription: 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. Read More Materials: Pharmacoepidemiology and Drug Safety, Volume 21, Issue Supplement S1, January 2012, Pages 72-81, DOI: 10.1002/pds.2320Additional InformationRelated Assessment(s): Sequential Testing MethodsPDS Supplement: The U.S. Food and Drug Administration's Mini-Sentinel ProgramContributorsAuthor(s): 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 PhDCorresponding Author: A. J. Cook, Biostatistics Unit, Group Health Research Institute, 1730 Minor Avenue, Suite 1600, Seattle, WA 98101, USA. Email: cook.aj@ghc.org
