在clinicaltrials.gov上报告临床试验结果的法律要求:一项队列研究
Nicholas J DeVito1, Seb Bacon1, Ben Goldacre1
1The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Lancet (London, England)
|January 21, 2020
概括
根据2007年食品和药物管理局修正法案 (FDAAA) 报告的临床试验结果很差,只有40.9%的试验达到1年的最后期限. 合规性没有改善,表明需要监管执法和赞助商行动.
科学领域:
- 临床试验的透明度
- 研究中的合规性
- 基于证据的医学
背景情况:
- 没有报告临床试验结果会扭曲证据基础,浪费研究资源.
- 2007年食品和药物管理局修订法案 (FDAAA) 要求在完成后的一年内在ClinicalTrials.gov上报告试验结果.
- 第一个受FDAAA最终规则影响的试验将于2018年1月报告.
研究的目的:
- 评估符合FDAAA2007年关于临床试验结果报告的最终规则.
- 确定与及时提交结果相关的试验特征.
- 审查发起人层面的趋势和报告要求的遵守情况.
主要方法:
- 从2018年3月到2019年9月的临床试验数据分析的队列研究.
- 包含所有适用的试验,由于FDAAA报告结果,但不包括不适用的或延迟报告的试验.
- 使用后勤回归和卡普兰-梅尔方法来评估合规性,相关因素和报告时间.
主要成果:
- 只有40. 9%的适用试验在一年的最后期限内报告了结果; 63. 8%的结果在任何时间提交.
- 自2018年7月以来,合规率没有提高,平均延迟时间为424天.
- 行业赞助商和管理众多试验的人员表现出明显更高的合规率.
结论:
- 符合FDAAA 2007年临床试验结果报告的最终规则是不可接受的低,并且没有改善.
- 缺乏监管执法可能是不合规的原因.
- 加强对赞助商合规的执法和公共审计是提高透明度的必要.
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