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Adaptive Design for Staggered-Start Clinical Trial
Yuan, Ao1; Li, Qizhai2; Xiong, Ming3; Tan, Ming T.1
AbstractIn 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.
Keywordadaptive design allocation proportion optimality sequential design staggered-start
Funding ProjectNational 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 Research AreaMathematical & Computational Biology ; Mathematics
WOS SubjectMathematical & Computational Biology ; Statistics & Probability
WOS IDWOS:000398329700003
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Document Type期刊论文
Corresponding AuthorYuan, Ao
Affiliation1.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
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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.
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