Methodological quality and reporting of ethical requirements in phase III cancer trials.
Fiche publication
Date publication
mai 2005
Auteurs
Membres identifiés du Cancéropôle Est :
Pr PESSAUX Patrick
Tous les auteurs :
Tuech JJ, Pessaux P, Moutel G, Thoma V, Schraub S, Herve C
Lien Pubmed
Résumé
BACKGROUND: The approval of a research ethics committee (REC) and obtaining informed consent from patients (ICP) could be considered the main issues in the ethics of research with human beings. The aim of this study was to assess both methodological quality and ethical quality, and also to assess the relationship between these two qualities in randomised phase III cancer trials. METHOD: Methodological quality (Jadad score) and ethical quality (Berdeu score) were assessed for all randomised controlled trials (RCTs) published in 10 international journals between 1999 and 2001 (n = 231). RESULTS: The mean Jadad score was 9.86 +/- 1.117. The methodological quality was poor in 75 RCTs (Jadad score
Référence
J Med Ethics. 2005 May;31(5):251-5.