Adaptive Design Theory and Implementation Using SAS and R: 2nd Edition (Paperback) book cover

Adaptive Design Theory and Implementation Using SAS and R

2nd Edition

By Mark Chang

Chapman and Hall/CRC

706 pages | 42 B/W Illus.

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pub: 2016-10-14
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Description

Get Up to Speed on Many Types of Adaptive Designs

Since the publication of the first edition, there have been remarkable advances in the methodology and application of adaptive trials. Incorporating many of these new developments, Adaptive Design Theory and Implementation Using SAS and R, Second Edition offers a detailed framework to understand the use of various adaptive design methods in clinical trials.

New to the Second Edition

  • Twelve new chapters covering blinded and semi-blinded sample size reestimation design, pick-the-winners design, biomarker-informed adaptive design, Bayesian designs, adaptive multiregional trial design, SAS and R for group sequential design, and much more
  • More analytical methods for K-stage adaptive designs, multiple-endpoint adaptive design, survival modeling, and adaptive treatment switching
  • New material on sequential parallel designs with rerandomization and the skeleton approach in adaptive dose-escalation trials
  • Twenty new SAS macros and R functions
  • Enhanced end-of-chapter problems that give readers hands-on practice addressing issues encountered in designing real-life adaptive trials

Covering even more adaptive designs, this book provides biostatisticians, clinical scientists, and regulatory reviewers with up-to-date details on this innovative area in pharmaceutical research and development. Practitioners will be able to improve the efficiency of their trial design, thereby reducing the time and cost of drug development.

Reviews

"Rigidly adhering to frequentist principles can only take one so far. Mark Chang dedicates his marvellous tome to ‘those who are striving toward a better way’; this book is an ideal vessel with which to begin."

International Society for Clinical Biostatistics, 2017

"… this text is a compilation of numerous adaptive trial designs that have been developed over the past few decades, including interim analyses, sample size re-estimation, biomarker enrichment, and response-adaptive treatment assignment. It is also an update to the first edition published in 2008 and includes 12 new chapters, as well as reformulations of several other chapters. … Two strengths of this text are the numerous examples that are included throughout and the inclusion of open-ended problems at the end of chapters to help readers work through some of the concepts on their own. Another strength of this text is its attempt to cover as many adaptive designs as possible. … This text is certainly a useful reference that covers approaches to adaptive clinical trial design, but would only be suitable for those with sufficient graduate-level statistical training and background in clinical trial design and programming."

—Thomas M. Braun, Department of Biostatistics, University of Michigan, writing in International Statistical Review, (2015), 83, 3, 511-522

Praise for the First Edition:

"The SAS and R programs are available on the web. This is good news since it avoids painful re-typing and error checking. … The book can provide all statisticians interested in the adaptive design field with an overview of the topic and software to run practical examples."

Pharmaceutical Statistics, 2011, 10

"… this book covers many of the different forms of adaptive design. … The book also provides both SAS and R code to implement the theory, making the implementation of the theory much more accessible to readers. … Its strength is that it provides an overview on many different types of adaptive designs, with an excellent source of references. … a useful resource in this relatively new and quickly developing field."

—Patrick Kelly, Statistics in Medicine, Vol. 29, 2010

"This book provides a thorough overview of adaptive designs in clinical trials similar to another book on adaptive designs coauthored by Dr. Chang (Chow and Chang, 2006), but using a more theoretical framework. … this book is an excellent addition to the biostatistics book series … . It provides a comprehensive summary of adaptive designs that have been developed, and includes about 400 references in the bibliography. The general theory behind most of the adaptive designs is helpful in understanding their advantages over fixed designs, as well as their potential pitfalls. The SAS and R programs associated with each adaptive design make the book practical as well."

Journal of the American Statistical Association, Vol. 104, No. 487, September 2009

"… this book provides a systematic introduction to adaptive design theory. It also gives trial examples and computing code to help readers construct a comprehensive understanding of adaptive designs. It is certainly a useful guide and reference for academic and industry statisticians alike."

—Feifang Hu, Biometrics, June 2009

"This easy-to-read book provides the reader with a unified and concise presentation of adaptive design theories, together with computer programs written in SAS and R for the design and simulation of adaptive trials. … The text, computer programs, and data sets will be of value to both practitioners and students alike."

International Statistical Review, 2008

Table of Contents

Introduction

Classic Design

Theory of Hypothesis-Based Adaptive Design

Method with Direct Combination of P-values

Method with Inverse-Normal P-values

Adaptive Non-Inferiority Design With Paired Binary Data

Trial Design and Analysis with Incomplete Paired Data

Implementation of N-Stage Adaptive Designs

Conditional Error Function Method and Conditional Power

Recursive Adaptive Design

Unblinded Sample-Size Re-Estimation Design

Blinded Sample Size Re-Estimation

Adaptive Design with Co-Primary Endpoint

Multiple-Endpoint Adaptive Design

Pick-the-Winners Design

The Add-Arms Design For Unimodal Response

Biomarker-Adaptive Design

Biomarker-Informed Adaptive Design

Survival Modeling and Adaptive Treatment Switching

Response-Adaptive Allocation Design

Bayesian Adaptive Dose Finding Design

Bayesian Phase I-II Adaptive Design

Adaptive Design for Biosimilarity Trial

Multi-Regional Adaptive Trial Design

Bayesian Adaptive Design

Planning, Execution, Analysis, and Reporting

Data Analysis of Adaptive Design

Debates in Adaptive Designs

SAS Adaptive Design Modules: SEQDESIGN Procedure

Appendix A: Random Number Generation

Appendix B: A Useful Utility

Appendix C: SAS Macros for Add-Arm Designs

Appendix D: Implementing Adaptive Designs in R

Bibliography

Index

About the Series

Chapman & Hall/CRC Biostatistics Series

Learn more…

Subject Categories

BISAC Subject Codes/Headings:
MAT029000
MATHEMATICS / Probability & Statistics / General
MED071000
MEDICAL / Pharmacology
MED090000
MEDICAL / Biostatistics