在轻度至中度阿尔茨海默氏症临床试验中研究伙伴类型和不良事件报告
Thuy V Lu1,2, Joshua D Grill2,3,4, Daniel L Gillen1,2,5,6
1Department of Statistics, University of California, Irvine, CA, USA.
Journal of Alzheimer's disease : JAD
|March 1, 2024
概括
研究伙伴类型没有影响阿尔茨海默病临床试验中的不良事件报告. 增加的访问与某些不良事件的报告率更高有关,为未来的试验安全监测提供了洞察力.
科学领域:
- 临床试验 临床试验
- 神经科学是一个神经科学.
- 药物监督 药物监督 药物监督
背景情况:
- 在阿尔茨海默病 (AD) 随机临床试验 (RCT) 中,对不良事件 (AE) 和严重不良事件 (SAE) 的监测至关重要.
- 所有的AD RCT都要求参与者与研究伙伴一起注册.
研究的目的:
- 调查轻度至中度AD试验中的AE报告率.
- 确定AE报告与研究合作伙伴特征之间的关联.
主要方法:
- 利用来自七个阿尔茨海默氏病合作研究RCT的安慰剂数据.
- 采用通用估计方程来评估跨访问的报告率异质性.
- 应用波桑回归来测试关于研究合作伙伴类型和时间承诺的假设.
主要成果:
- 每个参与者年份的AE报告率:1-3级AE (2.83),SAE (1.18).
- 较高的访问频率与1-2级AE和SAE报告的增加相关.
- 根据研究合作伙伴类型或时间承诺,AE报告中没有发现显著差异.
结论:
- 研究合作伙伴的特点没有影响AE报告率.
- 已建立的AE报告率可以在未来的AD研究中为安全评估提供信息,特别是那些缺乏控制臂的研究.
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