AN ADAPTIVE METHOD FOR ESTABLISHING A DOSE-RESPONSE RELATIONSHIP
AN ADAPTIVE METHOD FOR ESTABLISHING A DOSE-RESPONSE RELATIONSHIP
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DOI：
10.1002/sim.4780141410
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发表时间：
1995-07-30
影响因子：
2
通讯作者：
ROHMEL, J
中科院分区：
文献类型：
--
作者：
BAUER, P;ROHMEL, J
在剂量-效应试验中提出了一种多阶段抽样方法，其中可以在预先计划的适应性中期分析中进行剂量调整。通过Fisher乘积标准对来自不同阶段不相交样本中剂量效应单独检验的p值进行总体检验，以证明剂量-效应关系。基于这些p值，引入了早期停止的决策边界，拒绝了不存在剂量-反应关系的全局零假设。功率的自适应两阶段的程序使用一个特定的自适应规则进行比较，在广泛的模拟方差分析假设下的线性趋势的测试的功率。估计偏差也被量化。该程序可用于建立剂量-反应关系，不包括安慰剂治疗。
A multistage sampling method is proposed in dose-response trials, where dose adaptions can be performed in the preplanned adaptive interim analyses. The overall test for proving a dose-response relationship is performed by Fisher's product criterion for the p-values from the separate tests of a dose effect in the disjoint samples at the different stages. Based on these p-values decision boundaries for early stopping with the rejection of the global null hypothesis of no existing dose-response relationship are introduced. The power of the adaptive two-stage procedure using a particular adaptation rule is compared with the power of the test for a linear trend under analysis of variance assumptions in extensive simulations. The bias in estimation is also quantified. This procedure could be used for establishing a dose-response relationship without including a placebo treatment.