Adverse Reaction Signaling and Disproportionality Analysis: An Update

Abstract

There is an increased focus on signal detection, signal management, and the use of use of large collections of adverse event databases to meet the evolving regulatory mandates. The basic elements of signaling require an understanding of the different signaling methods, data mining approaches, and the strengths and limitations of disproportionality analysis. The application of signaling thresholds and the resulting statistical interpretation require an understanding of the methods themselves, as well as the strengths, limitations, and biases inherent in the adverse event data sources. This paper will highlight recent developments in these areas as well as provide cautions related to biases that affect reporting and analyses of adverse event databases.