Pharmacovigilance, signal detection and signal intelligence overview

The field of pharmacovigilance (or drug safety surveillance) has evolved significantly over the last few years. Most notably, various statistical methods have been developed and applied to the scan of large-scale adverse event (AE) databases to identify disproportionality in the reporting of specific product-AE combinations against marginal distributions as a background. This paper provides an overview of the safety signal detection framework and how statistical data mining methods complement traditional safety monitoring approaches in the framework. In addition, commonly used statistical methods and AE databases are described with some analytical examples. Finally, emerging trends and future considerations in safety signal detection are discussed. This paper provides a context for the topics related to cross-functional signal intelligence.