Blackwelder W C, Chang M A
Control Clin Trials. 1984 Jun;5(2):97-105. doi: 10.1016/0197-2456(84)90116-8.
Sample size graphs are given for clinical trials designed to test whether an experimental therapy is as effective as a standard therapy. We assume a dichotomous outcome variable and a one-sided test of the hypothesis that the probability of success with standard therapy is greater than the probability of success with experimental therapy by at least some specified amount delta. Graphs are given for significance level alpha = 0.01, 0.025, 0.05; type II error beta = 0.10, 0.20; and delta = 0.10, 0.20.
给出了样本量图表,用于旨在测试一种实验性疗法是否与标准疗法同样有效的临床试验。我们假设一个二分结果变量以及一个单侧检验假设,即标准疗法成功的概率比实验性疗法成功的概率至少高出某个指定量δ。给出了显著性水平α = 0.01、0.025、0.05;II类错误β = 0.10、0.20;以及δ = 0.10、0.20时的图表。