摘要
适应性设计因为具有设计灵活、节约成本、缩短研发时间、加快医药产品上市的优势,近年来越来越受到临床试验工作者和统计学家的关注。在临床试验探索期引入适应性设计很有意义,特别是复杂的新药临床试验。某降脂药临床试验采用双重适应性有偏硬币设计(doubly adaptive biased coin design,DBCD)适应性设计方案,在保证检验功效的前提下,将降脂药临床试验的Ⅱb期和Ⅱc期无缝链接起来。DBCD缩短了研发周期,减少了样本量,并且将更多的患者分配到较好的治疗组。
In recent years,adaptive design has been more and more popular among clinical trialists and statisticians. This is because the adaptive designs are often more flexibility,less cost,shorter in development time and faster in marketing pharmaceutical products. It is valuable and important to introduce adaptive designs in the exploration phase of clinical trials,especially complex drugs. In this study,we implement doubly adaptive biased coin design in one clinical trial of a new drug of reducing lipid-level. By combining phase IIb and phase IIc seamlessly,the proposed procedure maintains test power,greatly shortens the development time,and assigns more patients to better treatment groups.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2017年第4期389-393,共5页
Chinese Journal of New Drugs
基金
国家"重大新药创制"科技重大专项资助项目(2012ZX09303-010-002)
国家中医药管理局中医药科学技术研究专项资助项目(国中医药科2016ZX10)
国家自然科学基金资助项目(11371366)