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  • 标题:Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA
  • 本地全文:下载
  • 作者:Ramtin Talebi ; Rita F. Redberg ; Joseph S. Ross
  • 期刊名称:Trials
  • 印刷版ISSN:1745-6215
  • 电子版ISSN:1745-6215
  • 出版年度:2020
  • 卷号:21
  • 期号:1
  • 页码:675-678
  • DOI:10.1186/s13063-020-04603-9
  • 出版社:BioMed Central
  • 摘要: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 ClinicalTrials.gov . 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 ClinicalTrials.gov 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.
  • 关键词:Accurate reporting;Clinical trial reporting;FDA Amendments Act;Result reporting
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