Spontaneous reporting: how many cases are required to trigger a warning? [see comments]

Abstract

A statistical method is proposed to aid decisions on the recognition of new adverse drug reactions on the basis of spontaneous reports. The maximal number of associations between drug exposure and event is calculated from an independence test between drug and event, taking into account the expected incidence of that particular event in the general population. An example is given which illustrates the method. 1991 The British Pharmacological Society