适应性设计
临时的
临床试验
灵活性(工程)
食品药品监督管理局
临床研究设计
计算机科学
研究设计
中期分析
医学物理学
医学
风险分析(工程)
I类和II类错误
药物开发
人口
重症监护医学
药品
统计
数学
病理
药理学
考古
环境卫生
历史
出处
期刊:Annual Review of Medicine
[Annual Reviews]
日期:2014-01-14
卷期号:65 (1): 405-415
被引量:108
标识
DOI:10.1146/annurev-med-092012-112310
摘要
In recent years, the use of adaptive design methods in clinical trials based on accumulated data at interim has received much attention because of its flexibility and efficiency in pharmaceutical/clinical development. In practice, adaptive design may provide the investigators a second chance to modify or redesign the trial while the study is still ongoing. However, it is a concern that a shift in target patient population may occur after significant adaptations are made. In addition, the overall type I error rate may not be preserved. Moreover, the results may not be reliable and hence are difficult to interpret. As indicated by the US Food and Drug Administration draft guidance on adaptive design clinical trials, the adaptive design has to be a prospectively planned opportunity and should be based on information collected within the study, with or without formal statistical hypothesis testing. This article reviews the relative advantages, limitations, and feasibility of commonly considered adaptive designs in clinical trials. Statistical concerns when implementing adaptive designs are also discussed.
科研通智能强力驱动
Strongly Powered by AbleSci AI