论文部分内容阅读
目的 提出用于治疗 -对照差临床意义判别的样本量测定方法。方法 依据治疗 -对照差与最小临床承认疗效差量的比较推导出所需样本量测定公式 ,以MonteCarlo方法展示其行为。结果 当最小临床承认疗效差量取值为零时 ,本文方法还原为渐近正态法。由所测样本量产生的观测功效与预定功效吻合。结论 对于以判别治疗 -对照差临床意义为目的的临床试验 ,可用本文方法测定所需样本量。
Objective To propose a sample size determination method for the treatment-control differential clinical significance. Methods According to the comparison of treatment-control difference and minimum clinically recognized therapeutic difference, the required sample size determination formula was deduced, and its behavior was demonstrated with the Monte Carlo method. Results When the minimum clinically recognized therapeutic difference was zero, the method was reduced to asymptotic normal method. The observed efficacy resulting from the measured sample volume matches the pre-determined efficacy. Conclusion For clinical trials aimed at discriminating treatment-control clinical significance, the required sample size can be determined using this method.