Admissible two-stage designs for phase II cancer clinical trials that incorporate the expected sample size under the alternative hypothesis
Admissible two-stage designs for phase II cancer clinical trials that incorporate the expected sample size under the alternative hypothesis
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DOI：
10.1002/pst.501
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发表时间：
2012-03-01
影响因子：
1.5
通讯作者：
Thompson, Simon G.
中科院分区：
文献类型：
--
作者：
Mander, Adrian P.;Wason, James M. S.;Thompson, Simon G.
两阶段研究可以通过最小化单个特征（如最大样本量）来最佳地选择。然而，考虑到研究者最初会选择无效治疗，ECT和临床相关的DI？因此，最好选择一个同时考虑这些值的预期样本量的设计。最大样本量和两个预期样本量在这里结合起来，产生一个预期的损失函数？和设计是可接受的。考虑到成功的先验概率和总样本量的重要性，最小化预期损失给出了这种情况下的最优设计。一个新的三角形图来表示可容许设计有助于指导决策过程。H 0-最优、H1-最优、H 0-极大极小和H1-极大极小设计都是容许设计的特殊情况。常用的H 0-最优设计很少是好的，当允许停止e？凯西此外，使最大期望样本量最小化的d-minimax设计有时在损失函数下是可容许的。然而，结果可能会有所不同，每种情况都需要评估所有的容许设计。提供了这样做的软件。版权所有（c）2012约翰威利父子有限公司
two-stage studies may be chosen optimally by minimising a single characteristic like the maximum sample size. However, given that an investigator will initially select a null treatment e?ect and the clinically relevant di?erence, it is better to choose a design that also considers the expected sample size for each of these values. The maximum sample size and the two expected sample sizes are here combined to produce an expected loss function to ?nd designs that are admissible. Given the prior odds of success and the importance of the total sample size, minimising the expected loss gives the optimal design for this situation. A novel triangular graph to represent the admissible designs helps guide the decision-making process. The H 0-optimal, H 1-optimal, H 0-minimax and H 1-minimax designs are all particular cases of admissible designs. The commonly used H 0-optimal design is rarely good when allowing stopping for e?cacy. Additionally, the d-minimax design, which minimises the maximum expected sample size, is sometimes admissible under the loss function. However, the results can be varied and each situation will require the evaluation of all the admissible designs. Software to do this is provided. Copyright (c) 2012 John Wiley & Sons, Ltd.