Methodological quality and reporting of ethical requirements in phase III cancer trials.

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

https://www.ncbi.nlm.nih.gov/pubmed/15863678

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.