The Theory of Response-Adaptive Randomization in Clinical Trials

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Presents a firm mathematical basis for the use ofresponse-adaptive randomization procedures in practice The Theory of Response-Adaptive Randomization in ClinicalTrials is the result of the authors' ten-year collaboration aswell as their collaborations with other researchers ininvestigating the important questions regarding response-adaptiverandomization in a rigorous mathematical framework.Response-adaptive allocation has a long history in biostatisticsliterature; however, largely due to the disastrous ECMO trial inthe early 1980s, there is a general reluctance to use theseprocedures. This timely book represents a mathematically rigoroussubdiscipline of experimental design involving randomization andanswers fundamental questions, including: * How does response-adaptive randomization affect power? * Can standard inferential tests be applied followingresponse-adaptive randomization? * What is the effect of delayed response? * Which procedure is most appropriate and how can "mostappropriate" be quantified? * How can heterogeneity of the patient population beincorporated? * Can response-adaptive randomization be performed with more thantwo treatments or with continuous responses? The answers to these questions communicate a thoroughunderstanding of the asymptotic properties of each procedurediscussed, including asymptotic normality, consistency, andasymptotic variance of the induced allocation. Topical coverageincludes: * The relationship between power and response-adaptiverandomization * The general result for determining asymptotically bestprocedures * Procedures based on urn models * Procedures based on sequential estimation * Implications for the practice of clinical trials Useful for graduate students in mathematics, statistics, andbiostatistics as well as researchers and industrial and academicbiostatisticians, this book offers a rigorous treatment of thesubject in order to find the optimal procedure to use inpractice.

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Feifang Hu

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Clinical Trials Klinische Studien Medical Science Medical Sciences Special Topics Medizin Spezialthemen Medizin Spezialthemen Statistik Statistics Statistics Special Topics Statistik

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"The book provides a comprehensive overview of the theory ofrepsonse-adaptive radomization and is recommended to readers withan interest in this specialist area." (Statistics inMedicine, July 2008) "I can recommend this book for the intended target audiencewhich will include industry statisticians with a special interestin this area." (Pharmaceutical Statisitcs, 2008) "...this ground-breaking text is certainly a useful guideand reference for the academic and industry statistician alike."(Journal of the American Statistical Association, December2007) "This book is useful for graduate students inmathematics, statistics and biostatistics as well as researchersand industrial and academic biostatisticians."(Zentralblatt MATH, 2007) "...a milestone in the literature on response-adaptivedesigns in clinical trials." (Biometrics, September2007)
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