Publication related to RSI or an RSI staff member

Mining pharmacovigilance data using Bayesian logistic regression with James-Stein type shrinkage estimation.

Spontaneous adverse event reporting systems are widely used to identify adverse reactions to drugs following their introduction into the marketplace. In this article, a James-Stein type shrinkage estimation strategy was developed in a Bayesian logistic regression model to analyze pharmacovigilance data. This method is effective in detecting signals as it combines information and borrows strength across medically related adverse events. Computer simulation demonstrated that the shrinkage estimator is uniformly better than the maximum likelihood estimator in terms of mean squared error. This method was used to investigate the possible association of a series of diabetic drugs and the risk of cardiovascular events using data from the Canada Vigilance Online Database.

Authors

  • An, Lihua, An L, McLaughlin Centre for Population Health Risk Assessment, University of Ottawa, Ottawa, Ontario, Canada. lihuaan@yahoo.com

  • Fung, Karen Y, Fung KY,

  • Krewski, Daniel, Krewski D,

YEAR OF PUBLICATION: 2010
SOURCE: J Biopharm Stat. 2010 Sep;20(5):998-1012. doi: 10.1080/10543401003619056.
JOURNAL TITLE ABBREVIATION: J Biopharm Stat
JOURNAL TITLE: Journal of biopharmaceutical statistics
ISSN: 1520-5711 (Electronic) 1054-3406 (Linking)
VOLUME: 20
ISSUE: 5
PAGES: 998-1012
PLACE OF PUBLICATION: England
ABSTRACT:
Spontaneous adverse event reporting systems are widely used to identify adverse reactions to drugs following their introduction into the marketplace. In this article, a James-Stein type shrinkage estimation strategy was developed in a Bayesian logistic regression model to analyze pharmacovigilance data. This method is effective in detecting signals as it combines information and borrows strength across medically related adverse events. Computer simulation demonstrated that the shrinkage estimator is uniformly better than the maximum likelihood estimator in terms of mean squared error. This method was used to investigate the possible association of a series of diabetic drugs and the risk of cardiovascular events using data from the Canada Vigilance Online Database.
LANGUAGE: eng
DATE OF PUBLICATION: 2010 Sep
DATE COMPLETED: 20110114
DATE REVISED: 20131121
MESH DATE: 2011/01/15 06:00
EDAT: 2010/08/20 06:00
STATUS: MEDLINE
PUBLICATION STATUS: ppublish
LOCATION IDENTIFIER: 10.1080/10543401003619056 [doi]
OWNER: NLM

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Daniel Krewski

Chief Risk Scientist

Dr. Daniel Krewski is Chief Risk Scientist and co-founder of Risk Sciences International (RSI), a firm established in 2006 to bring evidence-based, multidisciplinary expertise to the challenge of understanding, managing, and communicating risk. As RSI’s inaugural CEO and long-time scientific...
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