Consistency of trial reporting between and corresponding publications: one decade after FDAAA

Trials. 2020 Jul 23;21(1):675. doi: 10.1186/s13063-020-04603-9.


The FDA Amendments Act (FDAAA) required that information for certain clinical trials, such as details about study design features and endpoints, as well as results, be publicly reported in . We conducted a cross-sectional analysis of phase III trials with primary results published between January 1, 2016, and June 30, 2017, in high-impact journals and found 74% contained at least one discrepancy between results reported in and the corresponding publication. Our findings underscore the necessity for monitoring of clinical trial information and result reporting between sources; a checklist may provide a systemized procedure for investigators and editors to monitor accurate reporting.

Keywords: Accurate reporting; Clinical trial reporting; FDA Amendments Act; Result reporting.

MeSH terms

  • Clinical Trials, Phase III as Topic / standards*
  • Cross-Sectional Studies
  • Humans
  • Registries*
  • Research Design*
  • Research Report / standards*
  • United States
  • United States Food and Drug Administration