Sharing clinical trial data: Maximizing benefits, minimizing risk
Cet article analyse les recommandations d'un rapport de l'"Institute of Medicine" américain sur la transparence en matière de données d'essais cliniques
All patients and their relatives want the best information possible regarding the effectiveness and safety of therapies. Responsible sharing of clinical trial data serves this public interest by strengthening the science that is the foundation of safe and effective clinical care. Sharing also fosters sound regulatory decisions, generates new research hypotheses, and increases the scientific knowledge gained from the contributions of clinical trial participants, the efforts of clinical trial investigators, and the resources of clinical trial funders. However, results from about one-third of clinical trials remain unpublished 4 years after trial completion, and much data from trials are never analyzed. Several large pharmaceutical companies and some academic investigators are already sharing clinical trial data, and the European Medicines Agency will do so beginning in 2015...
JAMA , article en libre accès, 2014