Multiple Analyses in Clinical Trials

Concentrating on the rationale for the analyses, the difficulties posed by their interpretation, easily understood solutions, and useful problem sets, this book will help clinical investigators understand multiple analysis procedures and key issues. It is written for advanced medical students, clinical investigators at all levels, research groups within the pharmaceutical industry, regulators at the local, state, and federal level, and biostatisticians.

ISBN 038700727X   Volumes 1 ISBN13 9780387007274 (What's this?)   Weight (grammes) 824 Publisher Springer-Verlag New York Inc.   Published in New York, NY Imprint Springer-Verlag New York Inc.   Series editor Dietz, K., et al Format Hardback   Series title Statistics for Biology and Health Publication date 02 Sep 2003   Height (mm) 234 Library of Congress 30445980   Width (mm) 156 DEWEY 610.72   Spine width (mm) 25 DEWEY edition DC21   Academic level Undergraduate, Postgraduate, Professional / Scholarly Pages 464

		Blossoms on a Healthy Plant		1
Ch. 1		Fundamentals of Clinical Trial Design		21
Ch. 2		Multiple Analyses and the Random Experiment		47
Ch. 3		The Lure and Complexity of Multiple Analyses		75
Ch. 4		Multiple Analyses and Multiple Endpoints		105
Ch. 5		Introduction to Multiple Dependent Analyses I		155
Ch. 6		Multiple Dependent Analyses II		199
Ch. 7		Introduction to Composite Endpoints		219
Ch. 8		Multiple Analyses and Composite Endpoints		239
Ch. 9		Introduction to Subgroup Analyses		267
Ch. 10		Subgroups II: Effect Domination and Controversy		287
Ch. 11		Subgroups III: Confirmatory Analyses		303
Ch. 12		Multiple Analyses and Multiple Treatment Arms		341
Ch. 13		Combining Multiple Analyses		359
Ch. 14		Conclusions: The Two-Front War		379
App. A		Case Reports and Causality		385
App. B		Estimation in Random Research		393
App. C		Relevant Code of Federal Regulations		403
App. D		Sample Size Primer		409
App. E		Additional Dependent Hypothesis Testing Results		417
		Index		431

From the reviews: "Moye's background as a statistician and MD makes him especially qualified to write this book!The clinical trial examples are a major strength of the book!His medical background and extensive clinical trials experience shine through." Statistics in Medicine, 2004, 23:3551-3559 "The many examples from well known clinical trials are clearly one of the strengths of this book. It is also fascinating to share the author's experience with the FDA where he attended many meetings of Advisory Committees."Biometrics, December 2005 "According to the preface, this book is written for clinical investigators and research groups within the pharmaceutical industry, medical students and regulators. ! I admire the eloquency of the author. ! The author does a remarkable job ! . Without any doubt, the book is a valuable source of ideas for the intended audience. For statisticians it is an interesting source of experimental setups, that are actually used in practice and that consequently are worth while to be studied." (dr H. W. M. Hendriks, Kwantitatieve Methoden, Issue 72B41, 2005) "The book is entertaining and informative, sufficiently informal to recruit and retain the intended non-statistical readership, but sufficiently formal to detail methods. The author effectively sets up each issue with examples and conceptual discussion, grounding all in realistic examples." (T. A. Louis, Short Book Reviews, Vol. 24 (2), 2004) "Here in this book is a special situation for clinical trials in which the investigator must do statistical analyses for a number of different response measurements. ! The author felt that the clinical investigators needed a book that they could understand. This book is his effort to reach that audience. ! I like the book's organization. ! I enjoyed leafing through this book and would certainly enjoy having the opportunity to sit down and read it." (Eric R. Ziegel, Technometrics, Vol. 46 (3), August, 2004) "This book is written primarily for clinical researchers who are interested in designing and analysing clinical trials. It concentrates on elucidating problems arising from multiple analyses in clinical trials ! . In general, the book is well written and easy to follow. ! Although this book is written for clinical investigators, I find it a useful reference book for statisticians in the pharmaceutical industry ! . Furthermore, senior statisticians may find the non-technical discussions and practical examples useful." (Shuying Yang, Pharmaceutical Statistics, Issue 3, 2004)

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