Trial Reporting in ClinicalTrials.gov — The Final Rule
Cet article présente les dernières réglementations édictées par les autorités américaines pour l'enregistrement des essais cliniques et de leurs résultats dans la base clinicaltrials.gov
Title VIII of the Food and Drug Administration (FDA) Amendments Act of 2007 (FDAAA) expanded the legal mandate for sponsors and others responsible for certain clinical trials of FDA-regulated drug, biologic, and device products to register their studies and report summary results information to ClinicalTrials.gov, which is managed by the National Library of Medicine at the National Institutes of Health (NIH). The statute expanded registration requirements and provided a legally defined timeline with specific requirements for the systematic reporting of summary trial results. Although statutory components took effect before 2010, the FDAAA directed the Department of Health and Human Services (HHS) to issue regulations regarding certain statutory provisions and to consider possible expansion of the requirements through rulemaking.
New England Journal of Medicine , article en libre accès, 2015