在clinicaltrials.gov注册的受控人类感染研究的分析
Danny Toomey1,2, Jupiter Adams-Phipps1, James Wilkinson1
11Day Sooner Research Team, Claymont, Delaware, USA.
BMJ open
|February 7, 2025
概括
在受控人类感染研究 (CHIS) 中,报告不良事件 (AE) 和参与者流动的差异很常见. 在ClinicalTrials.gov和出版物之间发现了40%的差异率,突出了需要一致的CHIS数据报告的需要.
科学领域:
- 传染性疾病 传染性疾病
- 临床试验方法论 临床试验方法论
- 数据科学数据科学数据科学
背景情况:
- 人类受控感染研究 (CHIS) 故意将志愿者暴露在感染病原体中.
- 之前的审查表明CHIS中不一致的不良事件 (AE) 报告,阻碍了数据聚合.
- 像ClinicalTrials.gov这样的临床试验注册表可能为标准化数据报告提供解决方案.
研究的目的:
- 为了评估clinicaltrials.gov从CHIS报告数据.
- 为了在CHIS中比较ClinicalTrials.gov和已发表的文章之间的参与者流和AE报告.
主要方法:
- 包括来自ClinicalTrials.gov的CHIS记录,通过API.gov访问.
- 将注册表数据与相关出版物的结果进行比较.
- 分析了基于赞助商类型,队列大小和偏差风险的差异.
主要成果:
- 分析了344个CHIS记录;40%显示注册表和出版物之间存在差异.
- 在公共资助的试验,较大的试验和具有偏见高风险的试验中,显著的差异更为常见.
- 在ClinicalTrials.gov报告的五种严重的副作用不在相关出版物中.
结论:
- 在CHIS报告中40%的差异率与其他临床试验相当.
- 中型,公开资助的试验显示出更多的报告不一致性.
- 提高CHIS报告的清晰度和一致性对于数据可靠性至关重要.
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