Abstract: Conventional signal detection methods based on disproportionality analysis are playing an important role in the process of signal detection of adverse drug reaction. However, these methods have their own drawbacks and the detection results are influenced greatly by the multiple hypothesis testing. These problems should be solved through new analysis strategy. In this article, we present the impact of multiple hypothesis testing on the signal detection and introduce the false discovery rate (FDR) methods that should solve the problem.

Key words: multiple hypothesis testing, adverse drug reaction, signal detection, false discovery rate