The use of historical controls in estimating simultaneous confidence intervals for comparisons against a concurrent control

The use of historical controls in estimating simultaneous confidence intervals for comparisons against a concurrent control
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使用历史控制来估计同时置信区间,以便与并发控制进行比较

DOI:
10.1016/j.csda.2012.05.010
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发表时间:
2012
期刊:
Comput. Stat. Data Anal.
影响因子:
--
通讯作者:
Hothorn
Hothorn
中科院分区:
--
文献类型:
--
作者:
Kitsche;Schaarschmidt;Hothorn

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在典型的毒性生物测定中,研究了未处理的对照组和几个剂量增加的组。使用既往试验的历史对照数据为统计分析提供了额外信息。假设二分响应变量(例如,死亡/存活)可以通过比较二项式比例进行适当分析,其中假定不存在对观察到的比率的任何混杂效应。使用历史对照组的二项式比例估计β先验分布的参数。使用该β先验允许将来自历史对照数据的知识应用于当前生物测定。虽然已经提出了这种情况下的趋势测试,我们的主要重点是针对建设的同时置信区间,允许在统计意义和生物相关性方面的解释。所提出的方法的性能进行了研究,在模拟研究的范围广泛的潜在情况。在许多情况下,新方法比常用方法更强大,更不保守。该方法通过评价文献中的长期致癌性示例来说明。
In a typical toxicity bioassay, an untreated control group and several groups of increasing dosage are studied. The use of historical control data from previous trials provides additional information for statistical analysis. It is assumed that dichotomous response variables (e.g., dead/alive) can be suitably analyzed through the comparison of binomial proportions, where any confounding effects on the observed rates are presumed to be absent. Binomial proportions from historical control groups are used to estimate the parameters of a beta prior distribution. Using this beta prior allows knowledge from the historical control data to be applied to a current bioassay. Although trend tests for this situation have been proposed, our main focus is directed towards the construction of simultaneous confidence intervals allowing for an interpretation both in terms of statistical significance and biological relevance. The performance of the proposed approach was investigated in simulation studies for a wide range of potential scenarios. In many cases, the new approach is more powerful and less conservative than a common approach. The method is illustrated by evaluating a long-term carcinogenicity example from the literature.
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