Methodological and ethical quality in phase III--breast cancer trials.
OBJECTIVE
The gold standard of Evidence Based Medicine remains the randomised controlled trial (RCT), which is the only tool that allows an approach to the "therapeutic truth". To reach credible conclusions, these trials need to be perfect in methodological and ethical quality. The purpose of this study is to evaluate methodological quality (MQ), ethical quality (EQ) and compliance with ethical requirements in phase III randomized clinical trials of breast cancer treatment.


METHODS
MQ was evaluated by the Jadad-scale and EQ by the Berdeu-score for all the randomised controlled clinical trials (RCT) (n = 137), published between January 2001 and December 2005 in 11 international journals.


RESULTS
Mean MQ was 9.88 +/- 1.43. MQ was insufficient (Jadad score pound 9) for 49 RCT (35,8%). Mean EQ was 0.45 +/- 0.12. Mean EQ for RCT with insufficient MQ (n = 49) was 0.43 +/- 0.12; Mean EQ for RCT with good MQ (Jadad score > 9)(n = 88) was 0.46 +/- 0.11. There was significant improvement in MQ depending on the year in which the study was started (p = 0.002). EQ was independent of the year of study's start (p = 0.134).There was no relationship between MQ or EQ and the number of patients included in the study (p = 0.53 and p = 0.1). There was a tendency towards correlation between MQ and EQ (p = 0.052), but the correlation between these two variables could not be considered as significant (r = 0.67). Informed consent from patients (ICP) was not obtained in 5.8% (n = 8) of the RCTs and the approval of a research ethics committee (REC) was not mentioned in 26.3% (n = 36) of the RCTs.


CONCLUSIONS
Good MQ and reporting of ethical requirements (EQ) reflects the respect shown to the patients during the whole research process. There are still deficiencies in EQ and MQ. Quality improvement requires education and appropriation by the scientific community, in particular, medical staff, of methodological and ethical basic rules concerning trials involving human beings.
Thoma
Véronique
V
IRCAD/EITS, 1 Place de l'Hôpital- BP 426 -67091 Strasbourg Cedex, France.
Bridoux
Valérie
V
Lefebure
Benoit
B
Wattiez
Arnaud
A
Nisand
Israël
I
Tuech
Jean-Jacques
JJ
D001943:Breast Neoplasms / Q000628:therapy*; D017326:Clinical Trials, Phase III as Topic / Q000379:methods / Q000592:standards*; D032984:Ethics, Research; D005260:Female; D006801:Humans; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards*