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  1. Sample size calculations for single group post-marketing cohort studies.

    Article - En anglais

    In pharmacoepidemiology, single group cohort is the most frequently proposed design to determine if the incidence rate of an adverse drug reaction among the exposed differs from a reference value.

    In many situations, the number of events expected in the cohort is too small to conduct sample size calculations based on the normal distribution.

    This paper proposes, for a single group cohort study, calculations and tables derived from the Poisson distribution.

    The results are based on a one-sided test with a 0.05 significance level and a power of 0.9 and 0.8. Two parameters have to be specified a priori : the expected incidence of the event under the null hypothesis and the minimum risk ratio to be detected.

    Mots-clés Pascal : Epidémiologie, Médicament, Toxicité, Pharmacovigilance, Taille échantillon, Loi Poisson, Etude cohorte, Méthodologie, Homme

    Mots-clés Pascal anglais : Epidemiology, Drug, Toxicity, Drug monitoring, Sample size, Poisson distribution, Cohort study, Methodology, Human

    Logo du centre Notice produite par :
    Inist-CNRS - Institut de l'Information Scientifique et Technique

    Cote : 94-0466060

    Code Inist : 002B30A01A1. Création : 199501.