Design and Analysis of Clinical Trials: Concept and Methodologies / Edition 1

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Overview

A unique, unifying treatment for statistics and science in clinical trials

What sets this volume apart from the many books dealing with clinical trials is its integration of statistical and clinical disciplines. Stressing communication between biostatisticians and clinical scientists, this work clearly relates statistical interpretation to clinical issues arising in different stages of pharmaceutical research and development. Plus, the principles presented here are universal enough to be easily adapted in non-biopharmaceutical settings.

Design and Analysis of Clinical Trials tackles concepts and methodologies. It not only covers statistical basics such as uncertainty and bias, design considerations such as patient selection, randomization, and the different types of clinical trials but also deals with various methods of data analysis, group sequential procedures for interim analysis, efficacy data evaluation, analysis of safety data, and more. Throughout, the book:
*Surveys current and emerging clinical issues and newly developed statistical methods
*Presents a critical review of statistical methodologies in various therapeutic areas
*Features case studies from actual clinical trials
*Minimizes the mathematics involved, making the material widely accessible
*Offers each chapter as a self-contained entity
*Includes illustrations to highlight the text

This monumental reference on all facets of clinical trials is important reading for physicians, clinical and medical researchers, pharmaceutical scientists, clinical programmers, biostatisticians, and anyone involved in this burgeoning area of clinical research. It can also be used as a textbook ingraduate-level courses in the field.

Incl. critical review of statistical methodologies; case studies; minimal mathematics; hypotheses testing; controls.

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Editorial Reviews

Booknews
Chow (biostatistics and data management, Covance, Inc.; Princeton, NJ) and Liu (statistics, National Cheng-Kung U.; Tainan, Taiwan) offer a balanced overview of the clinical issues and statistical concepts of importance to clinicians, biostatisticians, and other clinical scientists involved in evaluating the safety and efficacy of drug therapies in human subjects. Methodological considerations include: selection of patient and control samples, multicenter trials, adjustment for covariates, and data monitoring. Clinical priorities focus on the regulatory process and requirements, new drug applications, and analysis of adverse events. Includes statistical tables and SAS programs. Annotation c. by Book News, Inc., Portland, Or.
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Product Details

  • ISBN-13: 9780471134046
  • Publisher: Wiley, John & Sons, Incorporated
  • Publication date: 11/28/1998
  • Series: Wiley Series in Probability and Statistics Series , #342
  • Edition description: Older Edition
  • Edition number: 1
  • Pages: 672
  • Product dimensions: 6.58 (w) x 9.56 (h) x 1.52 (d)

Meet the Author

Shein-Chung Chow works in biostatistics and data management for Covance Inc.

Jen-Pei Liu works in biostatistics for the National Health Research Institutes and National Chen-Kung University, Taiwan." 1578701260

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Table of Contents

Preface
1 Introduction 1
2 Basic Statistical Concepts 47
3 Basic Design Consideration 93
4 Randomization and Blinding 121
5 Designs for Clinical Trials 176
6 Classification of Clinical Trials 212
7 Analysis of Continuous Data 259
8 Analysis of Categorical Data 306
9 Censored Data and Interim Analysis 363
10 Sample Size Determination 424
11 Issues in Efficacy Evaluation 483
12 Safety Assessment 535
References 572
Appendix A 599
Appendix B 627
Index 635
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