|
| 基于FDA新版指南草案浅谈适应性设计的发展 |
| Development of Adaptive Designs for Clinical Trials Based on the New FDA Draft Guidance |
| |
| DOI： |
| 中文关键词: 临床试验 适应性设计 FDA指南草案 适应性设计类型 |
| 英文关键词:Clinical trials Adaptive design FDA draft guidance Types of adaptive design |
| 基金项目:中国中医科学院院级第十二批自主选题资助项目（编号：Z0599） |
|
| 摘要点击次数: 538 |
| 全文下载次数: 373 |
| 中文摘要: |
| 摘 要在过去的二、三十年中，适应性设计一直是临床研究设计的热点。继2010年美国食品药品管理局（FDA）发布第一版适应性设计指南草案后，2018年9月FDA再次发布了第二版适应性设计指南草案：“Adaptive Designs for Clinical Trials of Drugs and Biologics Guidance for Industry”（以下简称“新版指南草案”）。此次颁布的指南草案在2010年版的基础上增加了临床试验中适应性设计的原则、适应性设计的类型、与适应性设计有关的注意事项及主题，如适应性设计计划中的模拟问题、贝叶斯适应性设计以及终点考虑和安全性考虑等内容，为临床试验的研究者们提供了非常重要的蓝本。本文将基于该新版指南草案内容，同时结合国内外适应性设计的发展概况，对适应性设计类型等相关的问题进行浅析，以期为相关研究人员提供参考。 |
| 英文摘要: |
| ABSTRACTIn the past two or three decades, adaptive design has been the hot topic in clinical research areas. After the first edition of the adaptive design draft guidance in 2010, FDA release the second edition which named “Adaptive Designs for Clinical Trials of Drugs and Biologics Guidance for Industry” in September 2018. Compared to the first edition, the new one updated and added the following contents: (1) adaptive designs in clinical trials; (2) types of adaptive design; (3) the considerations and themes related to adaptive design, e.g. simulations in adaptive design plans, Bayesian Adaptive designs,endpoint considerations and safety considerations, which provide a very important blueprint for researchers in clinical trials. Based on the content of the new draft guidance and the development of adaptive design at home and abroad, in this paper, we will focus on the adaptive design types and some critical issues in order to provide some useful reference for clinical researchers. |
| 查看全文 查看/发表评论 下载PDF阅读器 |
| 关闭 |
