临床试验中多处理组比较期中分析方法研究

目的 :介绍临床试验中多处理组比较期中分析方法。方法 :在多处理组比较分析方法的基础上 ,将两处理组比较成组序贯期中分析方法进一步扩展用于多处理组比较期中分析。结果 :多处理组期中分析包括各组的总检验和处理组间的两两比较。结论 :多处理组期中分析的关键是每次期中分析时界值的确定     

Using Graphical Displays of Exact Overall Significance Levels as a Guideline for Choosing a Significance Level for Pairwise Comparisons of a Dichotomous Variable

Abstract

Exact overall significance levels for selected sample sizes and response probabilities are graphically displayed when a dichotomous variable is compared between a placebo and two or more active treatments. A Z-statistic with a pooled variance estimator is used as the test statistic and critical values are based on the (1 ? α/2)th percentile of the standard normal distribution. These figures are used as a simple guideline for choosing significance levels that achieve a desired overall significance level. If an overall significance level of 0.05 is desired when comparing a placebo to two, three, or four active treatments, the recommended significance levels to be used for each of the two, three, or four pairwise comparisons are 0.027, 0.019, or 0.015. If an overall significance level of 0.10 is desired, the corresponding recommended significance levels are 0.055, 0.039, or 0.031.