Résumé
Le critère d’efficacité dans un essai clinique permet de mettre en évidence l’effet du traitement évalué en comparant les deux groupes de l’essai thérapeutique (le groupe traité et le groupe contrôle), par exemple la réponse tumorale ou le temps jusqu’à la progression tumorale. L’effet du traitement testé sera mis en évidence en comparant les groupes randomisés au moyen d’un test statistique (test du χ2 pour la réponse tumorale ou test du logrank pour le temps jusqu’à la progression tumorale). Si l’essai montre une différence entre les groupes, on s’intéressera à savoir, d’une part, si cet effet est statistiquement significatif (p < 0,5) et, d’autre part, s’il est cliniquement pertinent.
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Références
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Buyse, M., Cucherat, M. (2010). Critères d’efficacité des traitements de première ligne métastatique du cancer du sein. In: Cancer du sein en situation métastatique. Springer, Paris. https://doi.org/10.1007/978-2-8178-0076-9_35
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DOI: https://doi.org/10.1007/978-2-8178-0076-9_35
Publisher Name: Springer, Paris
Print ISBN: 978-2-8178-0075-2
Online ISBN: 978-2-8178-0076-9