Version
2.3
Date Updated
Tuesday, April 20, 2010
Descripton

The Food and Drug Administration Amendments Act (FDAAA) of 2007 (US Public Law 110-85) expanded the scope of registration of clinical trials at ClinicalTrials.gov, increased the amount of information that must be provided at the time of registration, required the inclusion of trials results, and imposed penalties for non-compliance. 

Previously, the Food and Drug Administration Modernization Act (FDAMA) of 1997, which established ClinicalTrials.gov, mandated the registration of FDA-regulated efficacy drug trials for serious or life-threatening diseases or conditions.

As of 2005, most medical journals, including the International Committee of Medical Journal Editors (ICMJE), require as a condition of consideration for publication, the prospective registration of certain clinical trials in a public trials registry.  Failing to register makes the results of the trial ineligible for publication in the ICMJE member journals.  ICMJE member publications include:

  • Journal of the American Medical Association (JAMA)
  • New England Journal of Medicine (NEJM)
  • Annals of Internal Medicine
  • The Lancet
  • Canadian Medical Association Journal (CMAJ)
  • The New Zealand Medical Journal
  • The Medical Journal of Australia
  • Norwegian Medical Journal
  • Croatian Medical Journal
  • Nederlands Tijdschrift voor Geneeskunde (Dutch Journal of Medicine)
  • Journal of the Danish Medical Association