Les Annals of Oncology, bonne revue européenne, commencent bien l'année 2013, avec la publication d'un article très commenté dans d'autres revues, dont le BMJ. Une équipe canadienne a analysé les publications d'essais de phase 3 dans le domaine du cancer du sein. L'article, d'accès gratuit, a montré que des biais existaient pour rapporter les résultats des critères primaires dits 'négatifs' : ce sont des spin. Cet article est bien fait. Ces données étaient connues, mais aucune étude n'avait été faite dans un seul domaine, et les données montraient moins de biais. Pour la toxicité, ce sont 67 % des résumés qui ont des biais. Voici le résumé de cet article :
Methods: PUBMED was searched from 1995 to 2011 to identify RCTs for breast cancer. Bias in the reporting of the PE and of toxicity was assessed using pre-designed algorithms. Associations of bias with the Journal Impact Factor (JIF), changes in the PE compared with information in ClinicalTrials.gov and funding source were evaluated.
Results: Of 164 included trials, 33% showed bias in reporting of the PE and 67% in the reporting of toxicity. The PE was more likely to be reported in the concluding statement of the abstract when significant differences favoring the experimental arm were shown; 59% of 92 trials with a negative PE used secondary end points to suggest benefit of experimental therapy. Only 32% of articles indicated the frequency of grade 3 and 4 toxicities in the abstract. A positive PE was associated with under-reporting of toxicity.
Merci à Pierre Biron
Hawkes N. Abstracts often do not accurately reflect trial results,study shows. BMJ 2013;346:f179 doi: 10.1136/bmj.f179
Vera-Badillo FE et al. Bias in reporting of end points of efficacy and toxicity in randomized, clinical trials for women with breast cancer. Annals of Oncology 2013 00: 1–6, 2013 doi:10.1093/annonc/mds636 (Advance access published January 9, 2013)
