Novel statistical tools for monitoring the safety of marketed drugs

Clin Pharmacol Ther. 2007 Aug;82(2):157-66. doi: 10.1038/sj.clpt.6100258. Epub 2007 May 30.


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.

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