PLANNED VERSUS ATTAINED DESIGN IN PHASE-II CLINICAL-TRIALS
PLANNED VERSUS ATTAINED DESIGN IN PHASE-II CLINICAL-TRIALS
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DOI：
10.1002/sim.4780110703
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发表时间：
1992-05-01
影响因子：
2
通讯作者：
DAHLBERG, S
中科院分区：
文献类型：
--
作者：
GREEN, SJ;DAHLBERG, S
标准的II期试验问题是决定是否继续测试新的药物组合）。通常情况下，我们测试零假设H0：p = p0与备择假设H（A）：p = p（A），其中p是响应概率。有各种两阶段第二阶段设计，包括根据各种标准的最佳设计。然而，在进行多中心试验时的实际考虑使得很难精确地遵循设计。我们研究了几种方法，以适应停止规则时，达到的样本量是不是计划的大小。我们发现，一个简单的方法，测试H（A）：p = p（A）在0.02的水平在第一阶段和H0：p = p0在0.055的水平在第二阶段的工作以及各种功率，p0 s和P（A）S。
The standard phase II trial problem is to decide whether or not to continue the testing of a new agent combination). Typically, one tests the null hypothesis H0:p = p0 against the alternative H(A):p = p(A), where p is the probability of response. There is available a variety of two-stage phase II designs, including optimal designs according to various criteria. Practical considerations in the conduct of multicentre trials, however, make it difficult to follow designs precisely. We investigate several approaches to adapting stopping rules when the attained sample size is not the planned size. We find that a simple approach of testing H(A):p = p(A) at the 0.02 level at the first stage and H0:p = p0 at the 0.055 level at the second stage works well across a variety of powers, p0s and P(A)S.