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Author Chow, Shein-Chung, 1955-

Title Adaptive design methods in clinical trials / Shein-Chung Chow, Mark Chang
Published Boca Raton, FL : Chapman & Hall/CRC, [2007]
Online access available from:
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Description 1 online resource (277 pages) : illustrations
Series Chapman & Hall/CRC biostatistics series ; 17
Chapman & Hall/CRC biostatistics series ; 17
Summary Although adaptive design methods are flexible and useful in clinical research, little or no regulatory guidelines are available. One of the first books on the topic, "Adaptive Design Methods in Clinical Trials" presents the principles and methodologies in adaptive design and analysis that pertain to adaptations made to trial or statistical procedures that are based on accrued data of ongoing clinical trials. The book also offers a well-balanced summary of current regulatory perspectives and recently developed statistical methods in this area. After an introduction to basic concepts and statistical considerations of adaptive design methods, the book questions the impact on target patient populations as the result of protocol amendments and discusses the generalization of statistical inference. The authors also present various adaptive design methods, including where hypotheses are modified during the conduct of clinical trials, for dose selection, and commonly used adaptive group sequential design methods in clinical trials.; Following a discussion of blind procedures for sample size re-estimation, the book describes statistical tests for seamless phase II/III adaptive designs and statistical inference for switching adaptively from one treatment to another. The book concludes with computer simulations and various case studies of clinical trials. By providing theoretical and computer simulation results, method comparisons, and practical guidelines for choosing an optimal design, "Adaptive Design Methods in Clinical Trials" fills the need for a unified, comprehensive, and updated resource in the clinical research and development of adaptive design and analysis
Bibliography Includes bibliographical references (pages 255-267) and index
Notes Print version record
Subject Adaptive sampling (Statistics)
Clinical trials -- Statistical methods.
Clinical trials.
Experimental design.
Clinical Trials as Topic -- methods.
Research Design.
Biometry -- methods.
Models, Statistical.
Form Electronic book
Author Chang, Mark.
ISBN 158488777X (electronic bk.)
9781584887775 (electronic bk.)
(alk. paper)
(alk. paper)