An algorithm for the classification of untoward events in large scale clinical trials.

Abstract

The algorithm described in this paper derives from a proposal by Karch and Lasagna and was developed for analysis of events reported in large scale clinical trials. It is presented in the form of a decision table which allows classification of events on a five-point scale according to the probability of their relationship with the drug under study. The degree of reproducibility of judgements made with the algorithm has been assessed and the decision table has been utilized for classifying all untoward events reported during an extended clinical trial with an anti-inflammatory drug.