Schäfer Helmut, Timmesfeld Nina, Müller Hans-Helge
Institute of Medical Biometry and Epidemiology, Philipps-University of Marburg, Bunsenstrasse 3, D-35037 Marburg, Germany.
Biom J. 2006 Aug;48(4):507-20. doi: 10.1002/bimj.200510234.
With adaptive design methods for clinical trials, design elements such as sample size or further interim sample sizes may be changed during the course of the trial depending on all previously collected data. The focus of the overview is on group sequential approaches where the types of adaptations need not be specified in advance. An overview of the different statistical approaches for adaptive design methods proposed in the literature is given, relations between these methods are described and some perspectives of application and for future research are discussed.
对于临床试验的适应性设计方法，诸如样本量或进一步的期中样本量等设计要素可能会在试验过程中根据所有先前收集的数据进行更改。本综述的重点是成组序贯方法，其中适应性类型无需事先指定。给出了文献中提出的适应性设计方法的不同统计方法综述，描述了这些方法之间的关系，并讨论了一些应用前景和未来研究方向。
