Cette étude parue le 14 août 2015 dans BMC Medicine est un bon travail supervisé par l'équipe du centre Cochrane français. Comme souvent, le titre n'est pas suffisamment informatif "Comparison of serious adverse events posted at ClinicalTrials.gov and published in corresponding journal articles" car la conclusion est claire : Many trials with serious adverse events (SAEs) posted at ClinicalTrials.gov are not yet published, omit the reporting of these SAEs in corresponding publications, or report a discrepant number of SAEs as compared with ClinicalTrials.gov. These results underline the need to consult ClinicalTrials.gov for more information on serious harms.
Un constat de plus, sans que réellement la communauté scientifique ne s'alarme !
Les auteurs ont analysés 300 essais de phase 3 ou 4 (tirés au sort parmi 1580) qui rapportaient des effets indésirables sévères dans le registre www.clinicaltrials.gov. Les résultats sont clairs et ont montré que les effets indésirables sévères n'étaient pas, pas suffisamment ou mal rapportés dans les publications. Voici le paragraphe résultats du résumé :"Among the sample of 300 trials with SAEs posted at ClinicalTrials.gov, 78 (26 %) did not have a corresponding publication, and 20 (7 %) had a publication that did not match the ClinicalTrials.gov record. For the 202 remaining trials, 26 published articles (13 %) did not mention SAEs, 4 (2 %) reported no SAEs, and 33 (16 %) did not report the total number of SAEs per treatment group. Among the remaining 139 trials, for 44 (32 %), the number of SAEs per group published did not match those posted at ClinicalTrials.gov. For 31 trials, the number of SAEs was greater at ClinicalTrials.gov than in the published article, with a difference ≥30 % for at least one group for 21. Only 33 trials (11 %) had a publication reporting matching numbers of SAE and describing the type of SAE."
