药物的未注册与注册随机对照试验中的有害影响:对临床试验的回顾性队列研究
Chang Xu1, Shiqi Fan2, Luis Furuya-Kanamori3
1Proof of Concept Center, Eastern Hepatobiliary Surgery Hospital, Third Affiliated Hospital, Second Military Medical University, Naval Medical University, Shanghai, China. xuchang2016@runbox.com.
BMC medicine
|October 11, 2024
概括
试验注册提高了临床研究的透明度. 非注册和追溯注册的药物试验显示伤害估计低于前性,这表明不良事件的潜在报告不足.
科学领域:
- 临床研究方法论临床研究方法论
- 药物安全和药物监督是药物安全和药物监督的重要组成部分.
- 生物统计学 生物统计学
背景情况:
- 试验登记对于临床研究的透明度和问责制至关重要.
- 选择性或不报告发现可以引入偏见.
- 调查注册状态对报告的有害影响的影响至关重要.
研究的目的:
- 评估试验注册状态对药物干预随机对照试验中估计的有害影响的影响.
- 为了比较前性注册,后性注册和未注册试验之间的危害估计.
主要方法:
- 在PubMed搜索药物危害试验 (2015-2020) 的系统审查和元分析.
- 包括至少五项试验的元分析,不同的注册状态和不良事件数据.
- 使用定向环形图 (DAG) 方法进行混协调和等级线性回归来比较危害估计 (赔率比率).
主要成果:
- 分析了629个元分析,包括10,069项试验;74.3%注册,23.9%未注册.
- 非注册 (OR=0.82) 和追溯注册 (OR=0.75) 的试验与前性注册的试验相比,损害估计较低.
- 在追溯注册和未注册的试验之间,没有发现损害估计的显著差异.
结论:
- 在未注册的试验中,药物危害可能被低估.
- 追溯登记没有明显减少对危害的选择性报告或没有报告.
- 强烈建议注册未来的试验,以确保准确报告与药物相关的危害.
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