Two-stage designs for clinical trials.
Two-stage designs for clinical trials.
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临床试验的两阶段设计。
DOI：
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发表时间：
1969
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通讯作者：
Day Ne
中科院分区：
文献类型：
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作者：
Day Ne
最近有几篇论文从增益函数的观点讨论了临床试验的设计(Anscombe[1963]，Colton[1963,1965]，在非常相似的主题上，Wetherill和Campling[1966]等)。这篇文章考虑了一种疾病有两种治疗方法的情况。对治疗的反应是一个连续变量，使用治疗的收益是反应的值的某个单调函数。给定数量的N名患者将需要这两种治疗中的一种或另一种，该试验的目的是以使预期收益尽可能大的方式将治疗分配给患者。实现最大预期收益的试验是相当复杂的，涉及每个患者决定使用哪种治疗方法，通常人们将注意力限制在设计较简单的试验上。Colton[1963]考虑了单阶段设计和序贯概率比检验，并在后来的论文[1965]中考虑了两种类型的两阶段设计。本文对较少约束和无约束的两阶段设计进行了构造和评价。这里使用的模型与Colton使用的模型相同，如下所示：
Several papers recently have discussed the design of clinical trials from a gain function viewpoint (Anscombe [1963], Colton [1963, 1965], and, on a very similar topic, Wetherill and Campling [1966] among others). This paper considers the situation in which two treatments are available for a particular ailment. The response to the treatment is a continuous variable, and the gain in using a treatment is some monotonic function of the value of the response. A given number N of patients will be in need of one or other of the two treatments, and the trial is aimed at allocating the treatments to the patients in such a way as to make the expected gain as large as possible. The trial which achieves the largest expected gain is of considerable complexity, involving a decision with each patient as to which treatment to use, and usually one confines attention to trials with a simpler design. Colton [1963] considered single-stage designs and sequential probability ratio tests, and in a later paper [1965] two types of two-stage designs. In this paper, less restricted and unrestricted two-stage designs are constructed and evaluated. The model used here is the same as used by Colton, and is as follows: