Excellent article d'un journaliste américain dans JAMA Internal Medicine en février 2015. Voici la copie du résumé de cet article :
Fifty-seven published clinical trials were identified for which an FDA inspection of a trial site had found significant evidence of 1 or more of the following problems: falsification or submission of false information, 22 trials (39%); problems with adverse events reporting, 14 trials (25%); protocol violations, 42 trials (74%); inadequate or inaccurate recordkeeping, 35 trials (61%); failure to protect the safety of patients and/or issues with oversight or informed consent, 30 trials (53%); and violations not otherwise categorized, 20 trials (35%). Only 3 of the 78 publications (4%) that resulted from trials in which the FDA found significant violations mentioned the objectionable conditions or practices found during the inspection. No corrections, retractions, expressions of concern, or other comments acknowledging the key issues identified by the inspection were subsequently published.
En pratique, la FDA conduit des audits sur des essais cliniques, et dans certains cas des fraudes sont découvertes. Le plus souvent ces audits mettent en évidence de mauvaises pratiques. Mais ces mêmes essais ont en général été publiés par des universitaires…. et les articles restent inchangés, sans corrections… c'est anormal.
