Durrleman S, Simon R
Biometric Research Branch, National Cancer Institute, Bethesda, Maryland 20892.
Biometrics. 1990 Jun;46(2):329-36.
Demonstrating therapeutic equivalence of two treatments is the goal of many clinical trials. For instance, when the toxicity of an effective standard treatment is of concern, much effort is devoted to developing new therapies that would be both as effective and less toxic. In this paper we review the special characteristics of these trials and describe sequential monitoring of equivalence studies using repeated confidence intervals. We show how sequential monitoring may be of particular value in this setting and critically discuss the choice of some important design parameters. We also provide tables for use when planning a sequential equivalence trial.
证明两种治疗方法的治疗等效性是许多临床试验的目标。例如，当一种有效的标准治疗方法的毒性令人担忧时，人们会投入大量精力来开发既有效又毒性较小的新疗法。在本文中，我们回顾了这些试验的特殊特征，并描述了使用重复置信区间对等效性研究进行序贯监测的方法。我们展示了序贯监测在这种情况下如何具有特殊价值，并批判性地讨论了一些重要设计参数的选择。我们还提供了在规划序贯等效性试验时使用的表格。
