Methodological Quality and Reporting of Ethical Requirements in Phase III Cancer Trials
Journal of Medical Ethics 2005 May; 31(5): 251-255
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
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Role Des Groupes Cooperateurs Dans La Qualite Ethique Et Methodologique Des Essais De Phase III en Cancerologie / Methodological and Ethical Quality in Phase III Cancer Trials: Role of the Cooperative Group Tuech, Jean-Jacques; Pessaux, Patrick; Moutel, Gregoire; Thoma, Veronique; Schraub, Simon; Herve, Christian (2004-10)