Search results for "Particular populations"
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Intérêt des méthodes alternatives dans l’évaluation du médicament dans les populations particulières
2020
Well conducted randomized clinical trial is considered gold standard in drug safety and efficacy evaluation. Drug development can be challenging in rare diseases, or in ethically sensitive populations (pregnant women, children, patient with cognitive defect), because of low number of subjects. The low rate of observed events at a sample scale in this population can lead to a biased evaluation of drugs compared to the general population. The aim of this work was to address alternative methods for drug evaluation in particular populations, especially pharmaco-epidemiology on populational database of the SNDS (Système National des Données de Santé). We first evaluate the safety of anti-TNFα in…