Abstract
The author has suggested an algorithm for the categorization of adverse reactions (AR) in large-scale clinical trials (Agents and Actions 1980; 7 [suppl]:318-322, Birkhäuser Verlag, Basel) and has been using it for the last 3 years in a Post-Marketing Surveillance (PMS) Italian national project. The proposed algorithm allows classification of drug-AR relationships in the following categories: unrelated, possible, probable, almost definite, and definite. It is based on questions considering: temporal relationship, other possible clinical causes for AR, whether AR is known or not for suspected drug, discontinuation of treatment (patient's judgment), dechallenge, and rechallenge. The conclusion is that algorithms are very useful for the assessment of whether an AR is drug-related or not, but even more for the standardization of judgment when a number of investigators are working on the same protocol. This situation is typical of PMS, where large cohorts are enrolled by hundreds of physicians.
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