title: Novel statistical tools for monitoring the safety of marketed drugs.
abstract: Robust tools for monitoring the safety of marketed therapeutic products are of paramount importance to public health. In recent years, innovative statistical approaches have been developed to screen large post-marketing safety databases for adverse events (AEs) that occur with disproportionate frequency. These methods, known variously as quantitative signal detection, disproportionality analysis, or safety data mining, facilitate the identification of new safety issues or possible harmful effects of a product. In this article, we describe the statistical concepts behind these methods, as well as their practical application to monitoring the safety of pharmaceutical products using spontaneous AE reports. We also provide examples of how these tools can be used to identify novel drug interactions and demographic risk factors for adverse drug reactions. Challenges, controversies, and frontiers for future research are discussed.
authors.affiliation: Department of Epidemiology and Population Health, Safety Evaluation and Risk Management, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Research Triangle Park, North Carolina, USA. june.s.almenoff@gsk.com
authors.forename: J S
authors.initials: JS
authors.lastname: Almenoff
authors.forename: E N
authors.initials: EN
authors.lastname: Pattishall
authors.forename: T G
authors.initials: TG
authors.lastname: Gibbs
authors.forename: W
authors.initials: W
authors.lastname: DuMouchel
authors.forename: S J W
authors.initials: SJ
authors.lastname: Evans
authors.forename: N
authors.initials: N
authors.lastname: Yuen
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data; D003627:Data Interpretation, Statistical; D004346:Drug Information Services / Q000706:statistics & numerical data; D016903:Drug Monitoring / Q000379:methods* / Q000706:statistics & numerical data / Q000639:trends; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000706:statistics & numerical data / Q000639:trends