摘 要：随着新药临床研究的投入不断增加，传统的平行随机对照研究设计不仅越来越成为新药申办者的障碍，同时也使临床研究者、受试者受到更严格的伦理与更大风险的束缚。临床适应性设计是指在临床试验开始后，根据试验中已经积累的信息，动态修改试验规则和（或）统计规则的某些方面，以保证试验的顺利进行，而不破坏试验的有效性、科学性和完整性的一种试验设计。适应性设计与传统设计比较具有设计灵活、节约成本、缩短研发时间、加快新药上市、符合伦理的优点。综述临床适应性设计产生的背景、主要内容、类型，以及在新药研究中的应用与实施等。

Abstract: With the increase of investment and cost in clinical research and development，the traditional designs of randomized control trials become the obstacles for candidates，because of ethical problems，escalating costs and greater risks．Clinical adaptive design is referred to a modification or a change made to the trial and/or statistical procedure during a clinical trial based on the accumulated data，without undermining the validity and integrity of the trial．Compared with the traditional design，adaptive design method is to give the investigator more flexibility for identifying the best clinical benefits of the test treatment，and to make the trial faster，cheaper，and more ethical and efficient．This article reviews the background，types，strategies，and implementation of adaptive design in clinical trials．