title: Compliance with results reporting at ClinicalTrials.gov.
abstract: BACKGROUND
  The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to ClinicalTrials.gov. We characterized the proportion of applicable clinical trials with publicly available results and determined independent factors associated with the reporting of results.
  
  
  METHODS
  Using an algorithm based on input from the National Library of Medicine, we identified trials that were likely to be subject to FDAAA provisions (highly likely applicable clinical trials, or HLACTs) from 2008 through 2013. We determined the proportion of HLACTs that reported results within the 12-month interval mandated by the FDAAA or at any time during the 5-year study period. We used regression models to examine characteristics associated with reporting at 12 months and throughout the 5-year study period.
  
  
  RESULTS
  From all the trials at ClinicalTrials.gov, we identified 13,327 HLACTs that were terminated or completed from January 1, 2008, through August 31, 2012. Of these trials, 77.4% were classified as drug trials. A total of 36.9% of the trials were phase 2 studies, and 23.4% were phase 3 studies; 65.6% were funded by industry. Only 13.4% of trials reported summary results within 12 months after trial completion, whereas 38.3% reported results at any time up to September 27, 2013. Timely reporting was independently associated with factors such as FDA oversight, a later trial phase, and industry funding. A sample review suggested that 45% of industry-funded trials were not required to report results, as compared with 6% of trials funded by the National Institutes of Health (NIH) and 9% of trials that were funded by other government or academic institutions.
  
  
  CONCLUSIONS
  Despite ethical and legal obligations to disclose findings promptly, most HLACTs did not report results to ClinicalTrials.gov in a timely fashion during the study period. Industry-funded trials adhered to legal obligations more often than did trials funded by the NIH or other government or academic institutions. (Funded by the Clinical Trials Transformation Initiative and the NIH.).
authors.affiliation: From the Department of Medicine, Division of Cardiology (M.L.A., E.D.P., R.M.C.), the Duke Clinical Research Institute, Duke University Medical Center (M.L.A., K.C., E.D.P., A.T., J.T.), and the Duke Translational Medicine Institute (R.M.C.), Duke University School of Medicine, Durham, NC.
authors.forename: Monique L
authors.initials: ML
authors.lastname: Anderson
authors.forename: Karen
authors.initials: K
authors.lastname: Chiswell
authors.forename: Eric D
authors.initials: ED
authors.lastname: Peterson
authors.forename: Asba
authors.initials: A
authors.lastname: Tasneem
authors.forename: James
authors.initials: J
authors.lastname: Topping
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
mesh_terms: D000465:Algorithms; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data; D016208:Databases, Factual / Q000706:statistics & numerical data; D030881:Disclosure / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000706:statistics & numerical data; D033161:Government Regulation; D006801:Humans; D037141:Mandatory Programs; D009317:National Library of Medicine (U.S.); D016016:Proportional Hazards Models; D012042:Registries; D012109:Research Support as Topic; D014481:United States; D014486:United States Food and Drug Administration