Healthy Skepticism Library item: 11440

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Almenoff JS, Pattishall EN, Gibbs TG, DuMouchel W, Evans SJ, Yuen N.
Novel statistical tools for monitoring the safety of marketed drugs.
Clin Pharmacol Ther 2007 Aug; 82:(2):157-66
http://www.nature.com/clpt/journal/v82/n2/abs/6100258a.html;jsessionid=5B6CB91FDA21892A00C116FA19C27A3B

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.

Keywords:
Publication Types: Review MeSH Terms: Adverse Drug Reaction Reporting Systems/statistics & numerical data Data Interpretation, Statistical* Drug Information Services/statistics & numerical data Drug Monitoring/methods* Drug Monitoring/statistics & numerical data Drug Monitoring/trends Humans Product Surveillance, Postmarketing/methods* Product Surveillance, Postmarketing/statistics & numerical data Product Surveillance, Postmarketing/trends