Reporting of results in clinicaltrials.gov and high-impact journals
Ces trois articles analysent les pratiques de publication des essais cliniques
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. 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.
JAMA , article en libre accès, 2013