[Critical review of the publication of a clinical trial].
THE MAIN OBJECTIVES OF THE CRITICAL REVIEW OF THE PUBLICATION OF A CLINICAL TRIAL: Are to underline the biases that may influence the validity and credibility of the results and to assess the quantity of the effect observed and the potential clinical impact.
Should be taken into account: publication in a journal with a reading committee, notoriousness of the author, the interest declared by the authors and the approval of an ethics committee.
Concerns the study objectives, clearly defined and integrated within the logics of a scientific context and suggesting concrete applications. A good quality demonstrative trial is prospective, controlled, randomized, and carried out double blind. The patients included are clearly characterized in order to know to what type of patient the research results can subsequently be applied. The principle end-point, whenever possible, is of clinical significance. The choice of the comparative arm is pertinent. The required number of patients has been calculated. The author has agreed to respect Good Clinical Practice and the statistical analyses are appropriate.


RESULTS
Presented clearly, must indicate the patients in whom the values observed have been calculated. The confidence intervals are provided. The principle analysis, in intent to treat, includes the principle end-point. The significance threshold is 5%. The extent of the difference between the results of the groups is detailed and of clinical significance. Any causal imputation is documented. The results of eventual sub-group analyses are only provided for information.
Concerns the scope of the results, their internal and external coherence with already validated data. The conclusion, factual, evokes the eventual therapeutic benefits of the research conducted. With regard to the latter, readers will be interested in the application of the results obtained to their own patients.
Bouvenot
Gilles
G
Laboratoire de Thérapeutique et de Méthodologie, Essais Cliniques, Faculté de Médecine de Marseille et INSERM U379. gbouvenot@ap-hm.fr
Villani
Patrick
P
Ambrosi
Pierre
P
D026683:Advisory Committees; D002986:Clinical Trials as Topic / Q000592:standards*; D016265:Conflict of Interest; D006801:Humans; D011643:Publishing; D015203:Reproducibility of Results