AN ALGORITHM FOR THE DESIGN OF EPIDEMIOLOGIC STUDIES APPLIED TO DRUG SURVEILLANCE

Spontaneous reporting of adverse drug reactions (ADRs), although commo nly used, is of limited efficacy for the establishment of causation, a nd must be complemented by more rigorous epidemiologic studies. This a rticle presents a decision algorithm that could be used as a tool in t he selection of the most appropriate study design to investigate the c ausal relationship between a given ADR and a drug. It is based on the incidence of the ADR, on the objective of the study determination of a ll the adverse effects of a given drug, or all the drugs increasing th e risk of occurrence of a given adverse event - and on the funds avail able to the researcher.