Hung H M, Chi G Y, Lipicky R J
Statistical Evaluation and Research Branch, Food and Drug Administration, Rockville, Maryland 20857.
Biometrics. 1993 Mar;49(1):85-94.
We consider the problem of studying several dose combinations of two drugs for a therapeutic endpoint in a multilevel factorial clinical trial. Two test statistics are constructed to test whether there exists at least one dose combination that is more effective than its component doses. Their distributions involve nuisance parameters quantifying the mean differences among the doses of the two component drugs. It is shown that their power functions achieve maxima as all the nuisance parameters approach infinity in absolute value. The significance levels of the two tests are derived and two alpha-level tests are proposed. Tables are given to provide the alpha-level critical values for these tests and to gain insights into their power performances.
我们考虑在多级析因临床试验中研究两种药物的几种剂量组合用于治疗终点的问题。构建了两个检验统计量来检验是否存在至少一种剂量组合比其组成剂量更有效。它们的分布涉及量化两种组成药物剂量之间平均差异的干扰参数。结果表明，当所有干扰参数的绝对值趋近于无穷大时，它们的功效函数达到最大值。推导了这两个检验的显著性水平，并提出了两个α水平检验。给出了表格以提供这些检验的α水平临界值，并深入了解它们的功效表现。
