适应性设计随机对照临床试验 Adaptive Design Randomized Controlled Clinical Trials

Abstract

近年来，适应性设计因其灵活性和高效率而在临床试验中得到了广泛的应用。在实践中，适应性设计可以为研究者提供第二次机会，在研究进行中调整试验设计。本文将重点从历史渊源、基本概念、设计类型、设计特点、案例解读、统计分析及报告规范等方面对适应性设计进行简要介绍。 Abstract: In recent years, adaptive design has been widely used in clinical trials due to its flexibility and efficiency. In practice, adaptive design can give researchers a second chance to adjust the trial design during the study. This article briefly introduced historical origins, basic concepts, design types, design characteristics, case analysis, statistical methods, and reporting standards of adaptive design.

Keywords

• 适应性设计
• 临床试验
• 成组序贯试验
• 随机对照
• adaptive design
• clinical trial
• group sequential trial
• randomized controlled trial