在比较生物可用性研究中的组对待相互作用效应
Helmut Schütz1,2,3, Divan A Burger4,5, Erik Cobo6
1Center for Medical Data Science of the Medical University of Vienna, 1090, Vienna, Austria. helmut.schuetz@bebac.at.
The AAPS journal
|April 17, 2024
概括
在比较生物可用性研究中对治疗组之间的相互作用进行测试是误导性的. 统计测试通常会产生错误的阳性结果,并且无法检测到真正的相互作用,这使得它在聚合数据分析中没有信息.
科学领域:
- 药物动力学和生物制药学
- 在临床试验中的统计建模.
背景情况:
- 由于实际限制,比较生物可用性研究经常使用多个受试者群体.
- 这种做法需要评估跨组数据的统计有效性.
- 在这种设计中,评估每组治疗相互作用的必要性和可靠性经常受到质疑.
研究的目的:
- 在比较生物可用性研究中调查治疗组相互作用的存在和影响.
- 通过模拟和元分析来确定统计测试对每组治疗相互作用的有效性.
- 评估在多组研究的统计模型中包括每组治疗相互作用的实用性.
主要方法:
- 利用模拟技术在各种条件下模拟每组治疗相互作用.
- 进行了一项元研究,分析了经过良好控制的比较生物利用性试验.
- 评估了统计测试的性能,以检测真假的组对组治疗相互作用.
主要成果:
- 对于每组治疗相互作用的统计测试经常产生假阳性,而没有真正的相互作用存在.
- 相反,该测试往往无法检测出真正的组对组治疗相互作用.
- 超级研究结果表明,检测到的相互作用在很大程度上处于统计学意义水平,这表明错误的阳性.
结论:
- 在比较生物可用性研究中对组对组治疗相互作用的测试在统计学上是不可靠的和误导性的.
- 目前的测试方法既没有信息性,也没有足够的敏感性来可靠地检测真实相互作用.
- 在统计模型中,将组对组治疗相互作用纳入单站比较生物利用性研究的统计模型,对多个组进行比较生物利用性研究,缺乏实际实用性.
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