Compliance with Results Reporting at ClinicalTrials.gov
Compliance with Results Reporting at ClinicalTrials.gov
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DOI：
10.1056/nejmsa1409364
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发表时间：
2015-03-12
影响因子：
158.5
通讯作者：
Califf, Robert M.
中科院分区：
文献类型：
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作者：
Anderson, Monique L.;Chiswell, Karen;Califf, Robert M.
美国食品和药物管理局修正案（FDAAA）要求及时向ClinicalTrials.gov报告适用临床试验的结果。我们描述了具有公开结果的适用临床试验的比例，并确定了与结果报告相关的独立因素。方法使用基于国家医学图书馆输入的算法，我们确定了2008年至2013年可能受FDAAA条款约束的试验（高度可能适用的临床试验，或HLACT）。我们确定了在FDAAA规定的12个月间隔内或5年研究期间任何时间报告结果的HLACT比例。我们使用回归模型来检查与12个月和整个5年研究期间报告相关的特征。从ClinicalTrials.gov上的所有试验中，我们确定了从2008年1月1日到2012年8月31日终止或完成的13，327项HLACT。在这些试验中，77.4%被归类为药物试验。共有36.9%的试验为II期研究，23.4%为III期研究; 65.6%由行业资助。只有13.4%的试验在试验完成后12个月内报告了总结结果，而38.3%的试验在2013年9月27日之前的任何时间报告了结果。及时报告与FDA监督、后期试验阶段和行业资金等因素独立相关。一项抽样审查表明，45%的行业资助的试验不需要报告结果，相比之下，由美国国立卫生研究院（NIH）资助的试验6%，由其他政府或学术机构资助的试验9%。CONCLUSIONSDespite伦理和法律的义务，及时披露调查结果，大多数HLACT没有报告结果，以及时的方式在研究期间的ClinicalTrials.gov。与NIH或其他政府或学术机构资助的试验相比，行业资助的试验更经常地遵守法律的义务。
BACKGROUNDThe Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to ClinicalTrials.gov. We characterized the proportion of applicable clinical trials with publicly available results and determined independent factors associated with the reporting of results.METHODSUsing an algorithm based on input from the National Library of Medicine, we identified trials that were likely to be subject to FDAAA provisions (highly likely applicable clinical trials, or HLACTs) from 2008 through 2013. We determined the proportion of HLACTs that reported results within the 12-month interval mandated by the FDAAA or at any time during the 5-year study period. We used regression models to examine characteristics associated with reporting at 12 months and throughout the 5-year study period.RESULTSFrom all the trials at ClinicalTrials.gov, we identified 13,327 HLACTs that were terminated or completed from January 1, 2008, through August 31, 2012. Of these trials, 77.4% were classified as drug trials. A total of 36.9% of the trials were phase 2 studies, and 23.4% were phase 3 studies; 65.6% were funded by industry. Only 13.4% of trials reported summary results within 12 months after trial completion, whereas 38.3% reported results at any time up to September 27, 2013. Timely reporting was independently associated with factors such as FDA oversight, a later trial phase, and industry funding. A sample review suggested that 45% of industry-funded trials were not required to report results, as compared with 6% of trials funded by the National Institutes of Health (NIH) and 9% of trials that were funded by other government or academic institutions.CONCLUSIONSDespite ethical and legal obligations to disclose findings promptly, most HLACTs did not report results to ClinicalTrials.gov in a timely fashion during the study period. Industry-funded trials adhered to legal obligations more often than did trials funded by the NIH or other government or academic institutions.