CLINICAL ETHICS

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

J J Tuech^1,2, P Pessaux³, G Moutel¹, V Thoma⁴, S Schraub^1,4 and C Herve¹

¹ Laboratoire d’Ethique Médicale et de Santé Publique, Faculté de Médecine Necker, Université Paris René Descartes, France
² Department of Digestive Surgery, University Hospital, France
³ Département de Statistiques Bio-médicales, CHU Angers, France
⁴ CRLCC Paul Strauss, Strasbourg, France

Correspondence to:
Correspondence to:
J J Tuech
Service de Chirurgie Digestive, Centre Hospitalier de Mulhouse, E-muller-moenchberg, 20 rue dr Laennec, 68070 Mulhouse cedex 1, France; tuechj{at}ch-mulhouse.fr

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 <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.

Conclusion: 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.

Abbreviations: ICP, informed consent from patients; RCT, randomised controlled trial; REC, research ethics committee

Keywords: clinical trials; ethics; method; randomised; quality

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