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Title Analysis of clinical trials using SAS : a practical guide / edited by Alex Dmitrienko, Gary G. Koch. [O'Reilly electronic resource]

Edition Second edition.
Publication Info. Cary, NC : SAS Institute, [2017]
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Description 1 online resource (1 volume) : illustrations
Note Previous edition published: 2005.
Bibliography Includes bibliographical references and index.
Contents Intro -- Contents -- Preface -- About This Book -- About These Authors -- Chapter 1: Model-based and Randomization-based Methods -- Chapter 2: Advanced Randomization-based Methods -- Chapter 3: Dose-Escalation Methods -- Chapter 4: Dose-finding Methods -- Chapter 5: Multiplicity Adjustment Methods -- Chapter 6: Interim Data Monitoring -- Chapter 7: Analysis of Incomplete Data -- Index.
Summary Analysis of Clinical Trials Using SAS®: A Practical Guide, Second Edition bridges the gap between modern statistical methodology and real-world clinical trial applications. Tutorial material and step-by-step instructions illustrated with examples from actual trials serve to define relevant statistical approaches, describe their clinical trial applications, and implement the approaches rapidly and efficiently using the power of SAS. Topics reflect the International Conference on Harmonization (ICH) guidelines for the pharmaceutical industry and address important statistical problems encountered in clinical trials. Commonly used methods are covered, including dose-escalation and dose-finding methods that are applied in Phase I and Phase II clinical trials, as well as important trial designs and analysis strategies that are employed in Phase II and Phase III clinical trials, such as multiplicity adjustment, data monitoring, and methods for handling incomplete data. This book also features recommendations from clinical trial experts and a discussion of relevant regulatory guidelines. This new edition includes more examples and case studies, new approaches for addressing statistical problems, and the following new technological updates: SAS procedures used in group sequential trials (PROC SEQDESIGN and PROC SEQTEST) SAS procedures used in repeated measures analysis (PROC GLIMMIX and PROC GEE) macros for implementing a broad range of randomization-based methods in clinical trials, performing complex multiplicity adjustments, and investigating the design and analysis of early phase trials (Phase I dose-escalation trials and Phase II dose-finding trials) Clinical statisticians, research scientists, and graduate students in biostatistics will greatly benefit from the decades of clinical research experience and the ready-to-use SAS macros compiled in this book.
Subject SAS (Computer file)
SAS (Computer file)
Clinical trials -- Statistical methods.
Études cliniques -- Méthodes statistiques.
Clinical trials -- Statistical methods
Added Author Dmitrienko, Alex, editor.
Koch, Gary G. (Gary Grove), editor.
SAS Institute, publisher.
Other Form: Print version: Analysis of clinical trials using SAS. Second edition. Cary, NC : SAS Institute, [2017] 162959847X 9781629598475 (OCoLC)994961702
ISBN 9781635261448
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