Adaptive Design for Staggered-Start Clinical Trial

doi:10.1515/ijb-2015-0011

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	Adaptive Design for Staggered-Start Clinical Trial
	Yuan, Ao 1; Li, Qizhai2 ; Xiong, Ming 3; Tan, Ming T.1
	2016-11-01
发表期刊	INTERNATIONAL JOURNAL OF BIOSTATISTICS
ISSN	2194-573X
卷号	12 期号:2 页码:17
摘要	In phase II and/or III clinical trial study, there are several competing treatments, the goal is to assess the performances of the treatments at the end of the study, the trial design aims to minimize risks to the patients in the trial, according to some given allocation optimality criterion. Recently, a new type of clinical trial, the staggered-start trial has been proposed in some studies, in which different treatments enter the same trial at different times. Some basic questions for this trial are whether optimality can still be kept? under what conditions? and if so how to allocate the the coming patients to treatments to achieve such optimality? Here we propose and study a class of adaptive designs of staggered- start clinical trials, in which for given optimality criterion object, we show that as long as the initial sizes at the beginning of the successive trials are not too large relative to the total sample size, the proposed design can still achieve optimality criterion asymptotically for the allocation proportions as the ordinary trials; if these initial sample sizes have about the same magnitude as the total sample size, full optimality cannot be achieved. The proposed method is simple to use and is illustrated with several examples and a simulation study.
关键词	adaptive design allocation proportion optimality sequential design staggered-start
DOI	10.1515/ijb-2015-0011
语种	英语
资助项目	National Cancer Institute (NCI)[R01CA164717] ; National Cancer Institute (NCI)[P30CA 051008] ; National Science Foundation of China[11371353] ; National Science Foundation of China[61134013] ; Breakthrough Project of Strategic Priority Program of the Chinese Academy of Sciences[XDB13040600]
WOS研究方向	Mathematical & Computational Biology ; Mathematics
WOS类目	Mathematical & Computational Biology ; Statistics & Probability
WOS记录号	WOS:000398329700003
出版者	WALTER DE GRUYTER GMBH
引用统计
文献类型	期刊论文
条目标识符	http://ir.amss.ac.cn/handle/2S8OKBNM/25123
专题	系统科学研究所
通讯作者	Yuan, Ao
作者单位	1.Georgetown Univ, Dept Biostat Bioinformat & Biomath, Washington, DC 20057 USA 2.Chinese Acad Sci, Acad Math & Syst Sci, Beijing 100190, Peoples R China 3.Cent China Normal Univ, Sch Math & Stat, Wuhan 430079, Peoples R China
推荐引用方式 GB/T 7714	Yuan, Ao,Li, Qizhai,Xiong, Ming,et al. Adaptive Design for Staggered-Start Clinical Trial[J]. INTERNATIONAL JOURNAL OF BIOSTATISTICS,2016,12(2):17.
APA	Yuan, Ao,Li, Qizhai,Xiong, Ming,&Tan, Ming T..(2016).Adaptive Design for Staggered-Start Clinical Trial.INTERNATIONAL JOURNAL OF BIOSTATISTICS,12(2),17.
MLA	Yuan, Ao,et al."Adaptive Design for Staggered-Start Clinical Trial".INTERNATIONAL JOURNAL OF BIOSTATISTICS 12.2(2016):17.