title: Trial registration and results disclosure: impact of US legislation on sponsors, investigators, and medical journal editors.
abstract: BACKGROUND
  Recently enacted federal legislation, the Food and Drug Administration Amendments Act of 2007 (FDAAA), mandates public registration and disclosure of results of "applicable" clinical trials of drugs, biologics and devices on www.clinicaltrials.gov. The law calls for registering more information about more trials than has been the policy of many medical journal editors to date. Beginning December 2007, results disclosure will occur in three stages initially with links to information from the FDA and NIH about FDA-approved products, as well as to Medline citations. A Basic Results Database will appear in September 2008, and an Expanded Results Database two years later. Results for trials of FDA-approved products must be posted within 12 months of trial completion. Such postings will not be peer reviewed or contain explanatory text or discussion. Sponsors who file regulatory submissions (IND, NDA, 510(k), PMA, etc.) to the FDA must certify compliance with FDAAA's registration and disclosure provisions. The FDA's determination of such compliance will be made public, and if non-compliance is not cured within 30 days, sponsors may be fined up to $10,000/day.
  
  
  CONCLUSIONS
  FDAAA requirements differ in a number of ways from those of the International Committee of Medical Journal Editors (ICMJE) and other journal editors, creating potential conflicts for sponsors and investigators who must comply with the law, and a need for better alignment of editors' policies with the law. The public will have access to massive amounts of clinical trial data as a result of FDAAA but it is unclear this will be useful to patients and prescribing physicians.
authors.affiliation: President and founding member of the International Society for Medical Publication Professionals, Briarcliff Manor, NY, USA. laurence_hirsch@bd.com
authors.forename: Laurence
authors.initials: L
authors.lastname: Hirsch
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D030881:Disclosure / Q000331:legislation & jurisprudence*; D035081:Editorial Policies; D033161:Government Regulation; D006801:Humans; D011643:Publishing / Q000639:trends; D012042:Registries; D014481:United States; D014486:United States Food and Drug Administration