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Sequential case series analysis for pharmacovigilance
Author(s) -
Hocine Mounia N.,
Musonda Patrick,
Andrews Nick J.,
Paddy Farrington C.
Publication year - 2009
Publication title -
journal of the royal statistical society: series a (statistics in society)
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.103
H-Index - 84
eISSN - 1467-985X
pISSN - 0964-1998
DOI - 10.1111/j.1467-985x.2008.00555.x
Subject(s) - pharmacovigilance , medicine , drug reaction , vaccine safety , measles , rubella , series (stratigraphy) , computer science , pediatrics , adverse effect , immunization , drug , virology , vaccination , pharmacology , immunology , paleontology , antigen , biology
Summary. The self‐controlled case series method is used to evaluate drug safety, particularly the safety of paediatric vaccines with respect to rare adverse reactions. We propose a group sequential version of the method for prospective surveillance of drug safety. We focus on the surveillance of new vaccines. We develop methods that are based on the sequential probability ratio test applied at predetermined surveillance intervals, using both simple and composite alternative hypotheses. We investigate the properties of the methods analytically in a simple setting and by simulations in more realistic scenarios. The methods are applied to data on influenza vaccine and Bell's palsy, and to data on measles, mumps and rubella vaccine and bleeding disorders.