马艳, 程千吉, 陆瑶, 宁金铃, 葛龙. 自适应平台试验在临床研究中的应用[J]. 协和医学杂志. DOI: 10.12290/xhyxzz.2023-0424
引用本文: 马艳, 程千吉, 陆瑶, 宁金铃, 葛龙. 自适应平台试验在临床研究中的应用[J]. 协和医学杂志. DOI: 10.12290/xhyxzz.2023-0424
MY Yan, CHENG Qianji, LU Yao, NING Jinling, GE Long. Explore the Applications and Challenges of Adaptive Design in Platform trial[J]. Medical Journal of Peking Union Medical College Hospital. DOI: 10.12290/xhyxzz.2023-0424
Citation: MY Yan, CHENG Qianji, LU Yao, NING Jinling, GE Long. Explore the Applications and Challenges of Adaptive Design in Platform trial[J]. Medical Journal of Peking Union Medical College Hospital. DOI: 10.12290/xhyxzz.2023-0424

自适应平台试验在临床研究中的应用

Explore the Applications and Challenges of Adaptive Design in Platform trial

  • 摘要: 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。

     

    Abstract: 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 briefly outlines the research progress , content and characteristics, common design types, statistical analysis, and case interpretation of adaptive design, introduces the concept, types, and applications of adaptive platform trials, in the hope to provide scientific references for further exploration of clinical trials and new drug development.

     

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