良好的试验设计是确保临床研究科学性和结果真实性的关键。 在试验设计时,统计学的充分运用可为临床方案的合理制定提供保障。 在方案中的总体设计、研究假设、主要指标选择和样本量计算等要素,背后都有对应的统计学思维。 本文针对此特点展开讨论,在给出概念、原理的同时,结合实例对试验设计过程中的统计学思维进行解读,具体对统计学在设计阶段的作用进行阐述,并指明可能对设计结果造成影响的相关因素。 强调在设计过程中临床和统计两个专业相结合的重要性。

Good study design is key to ensuring scientificity of clinical studies and authenticity of the results. During the study design, full use of statistics a guarantee of reasonable development of clinical programs. Statistical considerations are the fundamental elements in the overall design of the program,hypothesis generation,selection of primary endpoints,and sample size determination,etc. In this paper,the discussion is made in view of this characteristic, Statistical considerations in the study design process are interpreted combining with living examples, while concepts and principles are given simultaneously. The specific role of statistics in the design phase is elaborated, and the relevant factors are pointed out that possibly affect the design results. The importance is emphasized of the integration of clinical and statistical considerations for a good study design.