生物医药是国家'十二五'规划中七大战略性新兴产业之一。作为新药研发中的重要组成部分，临床试验是我国许多医疗机构和制药企业需要大力加强和创新的工作内容。近时期来，适应性设计以其高效灵活和节约成本等特性成为研究热点和发展方向。但关于该设计还存在大量理论方法和实际应用的问题有待理清和解决。 本项研究将着眼于一些含多终点的临床试验设计和含有一期内部试验的两阶段适应性设计。研究的目标是（1）建立关于多终点试验设计的一些基础理论方法，（2）对一些常用的含多终点两阶段适应性试验提出设计方案，（3）为该类设计建立相应的统计推断方法，制作分析软件。本项研究准备采用以非参数方法为主的分析路线和以数据自身驱动的两阶段适应性设计。这个研究方案的优点是能够获得一个安全稳健，适用性强的方法体系，从而能被更广泛的应用于临床试验及其相关研究，为高效节约的药物研发提供支持。

Biopharmaceutical industry is one of seven strategic new industries in the state the 12th 'five-year-plan'. As an important component of new drug development, innovative clinical trials play a key role and need to obe further developed by medical research institutes and pharmaceutical companies. Recently adaptive designs are widely recommended for their efficiency and cost-saving and become a new research direction. However, there remain many unsettled problems both in theory and in practice about adaptive designs. This proposal will focus on some problems of such designs involving multiple endpoints and two-stage designs with interim analysis. The goals of this study are (1) to establish some basic theory for single stage designs with multiple endpoints, (2) to develop some designs for two-stage adaptive designs with multiple endpoints, and (3) to establish statistical inference and develop statistical packages for the corresponding designs. We will use nonparametric methods and data-driven approach to solve these problems. The advantage of this approach lies on its robustness and simplicity for adaptation. So that the theory and methodology can be extended and widely applied in other related areas for efficient and cost-saving drug development.