在临床试验中报告非劣势差额.gov:系统性审查
Camille Reinaud1, Sandra Mavoungou1, David Hajage1
1Sorbonne Université, Institut National de la Santé et de la Recherche Médicale, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Pitié-Salpêtrière, Département de Santé Publique, Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), Paris, France.
JAMA network open
|April 7, 2025
概括
在ClinicalTrials.gov上报告临床试验中的非劣势差额很低. 在注册时强制报告可以提高透明度和试验结果可靠性.
科学领域:
- 临床试验方法论 临床试验方法论
- 监管科学 监管科学
- 生物统计学 生物统计学
背景情况:
- 非劣势差距对于设计和解释非劣势试验至关重要.
- 准确报告这一边际影响样本大小和结果评估.
- 报告的透明度对于科学严谨性至关重要.
研究的目的:
- 评估临床试验.gov.gov上的非劣势差额报告实践.
- 评估试验注册和出版之间的边际报告的一致性.
- 检查近期试验中非劣势差额披露的及时性.
主要方法:
- 在clinicaltrials.gov.gov上注册的非劣等性试验的系统审查.
- 审查有两个阶段:2010-2015年的试验及其出版物,以及2022-2023年新注册的试验.
- 手动提取方法特征,包括在注册时,注册后和出版物中的非劣势差额报告.
主要成果:
- 在注册时报告低的非劣势差额率 (在2010-2015年试验中为3.0%,在2022-2023年试验中为9.2%).
- 在出版物中报告 (94.2%) 和在clinicaltrials.gov上发布结果 (59.8%) 的比例更高.
- 观察到的一致性,当报告在注册和出版两个试验的一个小部分的试验.
结论:
- 在ClinicalTrials.gov上报告非劣势差额仍然低于最佳.
- 建议在注册时强制报告试验设计和非劣势差额.
- 提高透明度可以带来更可靠和可解释的临床试验结果.
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