title: Methodological quality and reporting of ethical requirements in phase III cancer trials.
abstract: 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.
  
  
  METHODS
  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 <9). The mean Berdeu score was 0.42 +/- 0.133. The mean ethical quality score for poor methodological quality RCTs (n = 75) was 0.39 +/- 0.133; it was 0.43 +/- 0.133 for good (n = 156) methodological quality RCTs (p = 0.07). There was improvement in ethical quality according to the year of commencement of the trials (p < 0.001). There was no correlation between methodological quality and the number of participating patients (R2 = 0.003, p = 0.78), between ethical quality and the number of participating patients (R2 = 0.003, p = 0.76 ), or between ethical quality and methodological quality (R2 = 0.012, p = 0.1). ICP and REC approval were not obtained for 21 and 77 trials respectively.
  
  
  CONCLUSIONS
  The association between methodological quality and the reporting of ethical requirements probably reflects the respect shown for patients during the whole research process. These results suggest that closer attention to the conduct of clinical research, as well as the reporting of its ethical aspects, is needed.
authors.affiliation: Laboratoire d'Ethique Médicale et de Santé Publique, Faculté de Médecine Necker, Université Paris René Descartes, France. tuechj@ch-mulhouse.fr
authors.forename: J J
authors.initials: JJ
authors.lastname: Tuech
authors.forename: P
authors.initials: P
authors.lastname: Pessaux
authors.forename: G
authors.initials: G
authors.lastname: Moutel
authors.forename: V
authors.initials: V
authors.lastname: Thoma
authors.forename: S
authors.initials: S
authors.lastname: Schraub
authors.forename: C
authors.initials: C
authors.lastname: Herve
mesh_terms: D017326:Clinical Trials, Phase III as Topic / Q000941:ethics* / Q000592:standards; D028744:Ethics Committees, Research; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D009369:Neoplasms / Q000628:therapy*; D010506:Periodicals as Topic; D016032:Randomized Controlled Trials as Topic / Q000941:ethics*; D012107:Research Design / Q000592:standards