Resumen de Reporting of Results in ClinicalTrials.gov and High-Impact Journals

Jessica E. Becker, Harlan M. Krumholz, Gal Ben Josef, Joseph S. Ross

• The 2007 Food and Drug Administration (FDA) Amendments Act expanded requirements for ClinicalTrials.gov, a public clinical trial registry maintained by the National Library of Medicine, mandating results reporting within 12 months of trial completion for all FDA-regulated medical products. Reporting of mandatory trial registration information on ClinicalTrials.gov is fairly complete, although there are concerns about its specificity; optional trial registration information is less complete.1- 4 To our knowledge, no studies have examined reporting and accuracy of trial results information. Accordingly, we compared trial information and results reported on ClinicalTrials.gov with corresponding peer-reviewed publications.