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Sequential case series analysis for pharmacovigilance

Hocine, Mounia N.; Musonda, Patrick; Andrews, Nick J. and Farrington, Paddy (2009). Sequential case series analysis for pharmacovigilance. Journal of the Royal Statistical Society: Series A (Statistics in Society), 172(1) pp. 213–236.

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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.

Item Type: Journal Item
Copyright Holders: 2009 Royal Statistical Society
ISSN: 0964-1998
Academic Unit/School: Faculty of Science, Technology, Engineering and Mathematics (STEM) > Mathematics and Statistics
Faculty of Science, Technology, Engineering and Mathematics (STEM)
Item ID: 12898
Depositing User: Paddy Farrington
Date Deposited: 19 Jan 2009 06:42
Last Modified: 07 Dec 2018 09:15
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