自适应平台试验在临床研究中的应用

Applications and Challenges of Adaptive Platform Trial

适应性设计以动态调整试验设计、减少资源浪费、提高试验效率等优势突破了新药研发的竞争态势,逐渐满足临床需求。近年来,结合适应性设计的平台试验作为一种创新研究模式,为新药研发增添了动力。本文简要概述适应性设计的研究进展、内容及特点、设计类型、统计分析方法和案例解读,介绍自适应平台试验的概念、类型及应用,以期为深入探索临床试验和新药研发提供科学参考。

Adaptive design,with advantages such as dynamically adjusting trial plans,reducing resource waste,and improving trial efficiency,has broken through the competitive situation of new drug development and gradually met the needs of clinical research.In recent years,the use of adaptive design in platform trials as an innovative research model has added impetus to new drug development.This article outlines the research progress,contents and characteristics,common design types,statistical analysis,and case interpretation of adaptive design,and introduces the concept,types,and applications of adaptive platform trials,with the hope of providing scientific reference for further exploration of clinical trials and new drug development.