危害报告中的非最佳实践:临床试验中的指标,复发和暴露持续时间的元流行病学研究
Qiao Huang1, Wen Wang2, Liang Zheng3
1Center for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China; Department of Evidence-Based Medicine and Clinical Epidemiology, Second School of Clinical Medicine, Wuhan University, Wuhan, China.
Journal of clinical epidemiology
|March 10, 2025
概括
临床试验往往没有充分报告不良事件的复发和多种多样的暴露时间. 未来的研究必须使用透明的指标,以便可靠地报告危害概况.
科学领域:
- 临床试验安全分析
- 药物监督 药物监督 药物监督
- 流行病学 流行病学
背景情况:
- "康索特危害2022声明"要求在临床试验中明确报告不良事件的持续时间和复发情况.
- 综合性风险评估需要适当的危害概况指标.
研究的目的:
- 为危害概况报告指标提供指导.
- 根据CONSORT Harms 2022的建议,评估当前的临床试验实践.
主要方法:
- 总结了四个报告指标:累计发病率,累计事件率,风险调整后的发病率 (EAIR) 和风险调整后的事件率 (EAER).
- 进行了116项在顶级医学期刊上发表的临床试验的元流行病学研究 (2023年9月至12月).
主要成果:
- 累积发病率是最常见的指标 (81.03%).
- 只有12.07%的试验报告了反复出现的不良事件,而5.17%的试验报告了不考虑复发的原因.
- 暴露时间的调整在试验中经常缺失,因为试验中断率不平等.
结论:
- 目前的临床试验实践不足以解决不良事件的复发和多种多样的暴露时间.
- 未来的试验应采用透明和复杂的指标,以实现多维和可靠的危害概况表示.
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