《FDAAA 实施十年后：ClinicalTrials.gov 与相应出版物之间试验报告的一致性》
Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA.
机构信息
Section of Cardiovascular Medicine, Department of Medicine, University of California at San Francisco School of Medicine, San Francisco, CA, USA.
Section of General Medicine, Department of Medicine, Yale School of Medicine, New Haven, CT, USA.
出版信息
Trials. 2020 Jul 23;21(1):675. doi: 10.1186/s13063-020-04603-9.
Abstract
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.
摘要
《食品和药物管理局修正案》（FDAAA）要求在 ClinicalTrials.gov 上公开报告某些临床试验的信息，如研究设计特征和终点的详细信息，以及结果。我们对 2016 年 1 月 1 日至 2017 年 6 月 30 日在高影响力期刊上发表的主要结果为三期试验进行了横断面分析，发现 74%的试验结果在 ClinicalTrials.gov 和相应的出版物之间至少存在一处差异。我们的研究结果强调了对临床试验信息和结果报告进行来源之间监测的必要性；检查表可能为研究人员和编辑提供一个系统的程序，以监测准确的报告。
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