Sample size calculations for single group post-marketing cohort studies.
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
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 94-0466060
Code Inist : 002B30A01A1. Création : 199501.