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Table of Contents Biostatistics Methods & Applications Exercises and Solutions in Biostatistical Theory ................3 Bayesian Missing Data Problems: EM, Data Augmentation and Noniterative Computation ........3 Testing Statistical Hypotheses of Equivalence and Noninferiority, Second Edition..........................................3 Antedependence Models for Longitudinal Data ..............3 Missing Data in Longitudinal Studies: Strategies for Bayesian Modeling and Sensitivity Analysis ................4 Handbook of Markov Chain Monte Carlo ........................4 Handbook of Spatial Statistics ..........................................4 Longitudinal Data Analysis ..............................................4 Principles of Uncertainty ..................................................5 Computational Biostatistics SAS and R: Data Management, Statistical Analysis, and Graphics....................................................................5 Using SAS for Data Management, Statistical Analysis, and Graphics....................................................................5 Using R for Data Management, Statistical Analysis, and Graphics....................................................................5 Practical Statistical Methods: A SAS Programming Approach ........................................6 Bayesian Analysis Made Simple: An Excel GUI for WinBUGS ..............................................6 Analysis of Questionnaire Data with R ..............................6 A Handbook of Statistical Analyses using SAS, Third Edition ....................................................................6 A Handbook of Statistical Analyses Using R, Second Edition ................................................................7 Clinical Trials & Pharmaceutical Stats Controversial Statistical Issues in Clinical Trials..................7 Clinical Trial Methodology................................................7 Clinical Trial Data Analysis Using R ..................................7 Bayesian Adaptive Methods for Clinical Trials ..................8 Monte Carlo Simulation for the Pharmaceutical Industry: Concepts, Algorithms, and Case Studies............8 Dose Finding by the Continual Reassessment Method ....8 Design and Analysis of Quality of Life Studies in Clinical Trials, Second Edition ......................................8 Cluster Randomised Trials ................................................9 Data and Safety Monitoring Committees in Clinical Trials......9 Sample Sizes for Clinical Trials ..........................................9

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Sample Size Calculations in Clinical Research, Second Edition ................................................................9 Adaptive and Flexible Clinical Trials ................................10 Handbook of Adaptive Designs in Pharmaceutical and Clinical Development ..............................................10 Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition ............................10 Multiple Testing Problems in Pharmaceutical Statistics ..10 Multiple Comparisons Using R ......................................11 Translational Medicine: Strategies and Statistical Methods ........................................................11 Survival Analysis Flexible Parametric Survival Analysis Using Stata: Beyond the Cox Model ..................................................11 An Introduction to Survival Analysis Using Stata, Third Edition ..................................................................11 Frailty Models in Survival Analysis ..................................12 Modeling Survival Data Using Frailty Models ................12 Design and Analysis of Clinical Trials with Time-to-Event Endpoints ................................................12 Epidemiology Statistical Thinking in Epidemiology ..............................12 Biosurveillance: Methods and Case Studies ....................13 Measurement Error: Models, Methods, and Applications ............................................................13 Bayesian Disease Mapping: Hierarchical Modeling in Spatial Epidemiology..................................................13 Medical Diagnostics & Testing Statistical Evaluation of Diagnostic Performance: Topics in ROC Analysis ..................................................13 ROC Curves for Continuous Data ..................................14 Advanced Bayesian Methods for Medical Test Accuracy ....14 Bayesian Methods for Measures of Agreement ..............14 Measures of Interobserver Agreement and Reliability, Second Edition ..............................................................14 Bioinformatics & Statistical Genetics Bayesian Modeling in Bioinformatics ..............................15 Clustering in Bioinformatics and Drug Discovery............15 Statistics in Human Genetics and Molecular Biology ......15 Statistical and Computational Pharmacogenomics ........15 Design and Analysis of Non-Inferiority Trials ..................16

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Biostatistics Methods & Applications

New!

Exercises and Solutions in Biostatistical Theory Lawrence Kupper, Brian Neelon, and Sean M. O’Brien “… it should appeal to … anyone interested in mastering the concepts of probability and mathematical statistics … Students and instructors of such courses as well as anyone studying on their own to brush up their knowledge of statistical theory will find the book very useful. … Overall, I like this book very much. The problems are carefully chosen and cover a wide range of real-world applications of biostatistical methods. … I have taught courses in mathematical statistics on several prior occasions and wish a book like this was available earlier.” —Kaushik Ghosh, Journal of Biopharmaceutical Statistics

Catalog no. C7222, January 2011, 420 pp. Soft Cover, ISBN: 978-1-58488-722-5, $49.95 / £24.99

Testing Statistical Hypotheses of Equivalence and Noninferiority Second Edition Stefan Wellek Central Institute of Mental Health, Mannheim, and University of Heidelberg, Germany

“… The update is timely and includes some material on new subjects as well as updates of material presented in the original edition. … this book deserves a place on the bookshelf of the library of every pharmaceutical company. … this book remains the standard for texts on equivalence studies. The addition of information on noninferiority analyses is welcome. A copy of this book should be available to every statistician who works on clinical trials.” —Brian Wiens, Journal of Biopharmaceutical Statistics, Issue 3, 2011

Catalog no. K10408, 2010, 431 pp. ISBN: 978-1-4398-0818-4, $99.95 / £63.99 Also available as an eBook

Also available as an eBook

Bayesian Missing Data Problems EM, Data Augmentation and Noniterative Computation

Antedependence Models for Longitudinal Data Dale L. Zimmerman

Ming T. Tan

University of Iowa, Iowa City, USA

University of Maryland, Baltimore, USA

Vicente A. Núñez-Antón

Guo-Liang Tian and Kai Wang Ng

The University of the Basque Country (UPV/EHU), Bilbao, Spain

University of Hong Kong, Kowloon

This book presents solutions to missing data problems through explicit or noniterative sampling calculation of Bayesian posteriors, based on the inverse Bayes formulae. The authors focus on exact numerical solutions, a conditional sampling approach via data augmentation, and a noniterative sampling approach via EM-type algorithms. They describe Monte Carlo simulation, numerical techniques, and optimization methods. The book illustrates the methods with biostatistical models and real-world applications, including mixed effects and hierarchical models, nonresponse and contingency tables, and the constrained parameter problem reformulated as a missing data problem. Catalog no. C7749, 2010, 344 pp. ISBN: 978-1-4200-7749-0, $89.95 / £57.99 Also available as an eBook

“…This book is the first one dedicated entirely to antedependence models … The material presented is well organized. … Several relevant R functions are available for download from the first author’s webpage … a welcome addition to the bibliography of longitudinal data, combining rigorous statistical presentation with interesting real life examples.” —Raúl E. Macchiavelli, SORT, Vol. 34 (1), 2010

“… I enjoyed reading the book … an excellent addition to the literature and I recommend it to any professional statistician.” —Journal of Time Series Analysis, 2010

Catalog no. C6426, 2010, 288 pp. ISBN: 978-1-4200-6426-1, $89.95 / £57.99 Also available as an eBook

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Biostatistics Methods & Applications

Missing Data in Longitudinal Studies Strategies for Bayesian Modeling and Sensitivity Analysis

Handbook of Spatial Statistics

Michael J. Daniels

Edited by

University of Florida, Gainesville, USA

Alan E. Gelfand, Peter J. Diggle, Montserrat Fuentes, and Peter Guttorp

Joseph W. Hogan Brown University, Providence, Rhode Island, USA

“… They [the authors] have gone further than anyone else in developing methods for the not missing at random (NMAR) case. … an excellent introduction and a first-rate treatment of cutting-edge topics. …” —Paul D. Allison, Significance, September 2010

“This text is the only Bayesian textbook that provides a contemporary and comprehensive treatment of Bayesian approaches to a common and critically important topic. … I have used the techniques proposed in the text with much success … . I strongly endorse this book.” —Sharon-Lise Normand, Harvard School of Public Health, Boston, Massachusetts, USA

Catalog no. C6099, 2008, 328 pp. ISBN: 978-1-58488-609-9, $85.95 / £54.99

“… a successor of the famous work by Noel Cressie. The authors are all high-ranked statisticians with great experience in both teaching and research. … the reviewer warmly recommends this great volume to all spatial statisticians. …” —Biometrical Journal, 53 (2011), 1

“…I strongly recommend Handbook of Spatial Statistics as a textbook for an advanced class in spatial statistics and as a reference book for anyone dealing with spatial data. It will definitely be one of my favorite books in the field for years to come, and I am convinced that it will be the case for many scientists. …” —Statistics and Computing, October 2010

Catalog no. C7287, 2010, 619 pp. ISBN: 978-1-4200-7287-7, $99.95 / £63.99 Also available as an eBook

Also available as an eBook

New!

Handbook of Markov Chain Monte Carlo

Longitudinal Data Analysis Edited by

Edited by

Steve Brooks, Andrew Gelman, Galin Jones, and Xiao-Li Meng “… The handbook provides a state-of-the-art view of a technology that has revolutionized contemporary model fitting. Researchers at all levels of familiarity with MCMC will find novel morsels of material to chew on.”

Garrett Fitzmaurice, Marie Davidian, Geert Verbeke, and Geert Molenberghs “… The editors clearly have taken great care to ensure a whole document rather than a disjointed patchwork typical of similar collections. … Experienced researchers and those new to the field will find useful material here. …” —Biometrics, September 2010

—Alan E. Gelfand, Duke University, Durham, North Carolina, USA

“… This is a wonderful assemblage of the state of the art in MCMC methods from a world-class collection of probabilists, statisticians, and biostatisticians known for their accomplishments in this area. … a must-read for anyone wanting a comprehensive, modern, and in-depth look at MCMC.” —Bradley P. Carlin, University of Minnesota, Minneapolis, USA

Catalog no. C7941, May 2011, 619 pp. ISBN: 978-1-4200-7941-8, $99.95 / £63.99

“… Longitudinal Data Analysis is the first book to collect and sort through many of the most important developments. … a wellorganized, excellent overview of the state of the art in modeling longitudinal data and would make a useful supplement to the library of anyone that analyzes this type of data.” —Journal of the American Statistical Association, June 2010

Catalog no. C6587, 2009, 632 pp. ISBN: 978-1-58488-658-7, $99.95 / £62.99 Also available as an eBook

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MBCBST1 MC_ISSUU:MBCBST1 MC 7/13/11 8:47 AM Page 5

Biostatistics Methods & Applications

Computational Biostatistics New!

Using SAS for Data Management, Statistical Analysis, and Graphics

New!

Principles of Uncertainty

Ken Kleinman

Joseph B. Kadane

Nicholas J. Horton

Carnegie Mellon University, Pittsburgh, Pennsylvania, USA

“It’s a lovely book, one that I hope will be widely adopted as a course textbook.” —Michael Jordan, University of California, Berkeley, USA

“A careful, complete, and lovingly written exposition of the subjective Bayesian viewpoint by one of its most eloquent and staunch defenders. Summarizes a lifetime of theory, methods, and application developments for the Bayesian inferential engine. A must-read for anyone looking for a deep understanding of the foundations of Bayesian methods and what they offer modern statistical practice.” —Bradley P. Carlin, University of Minnesota, Minneapolis, USA

Catalog no. K12848, May 2011, 503 pp. ISBN: 978-1-4398-6161-5, $89.95 / £57.99

Harvard Medical School, Boston, Massachusetts, USA Smith College, Northampton, Massachusetts, USA

“This book is a well-organized reference text that summarizes and illustrates SAS code and common SAS features most often used by statistical analysts and others engaged in research and data analysis. … a handy reference tool for common tasks performed in SAS due to the book’s task-oriented nature and the broad range of topics covered. This book would also nicely serve as a supplemental reference text for an introductory SAS programming class.” —Journal of Biopharmaceutical Statistics, Issue 3, 2011

Catalog no. K11361, January 2011, 305 pp. Soft Cover, ISBN: 978-1-4398-2757-4, $59.95 / £38.99 Also available as an eBook

Computational Biostatistics New!

SAS and R Data Management, Statistical Analysis, and Graphics

Using R for Data Management, Statistical Analysis, and Graphics Nicholas J. Horton Smith College, Northampton, Massachusetts, USA

Ken Kleinman Harvard Medical School, Boston, Massachusetts, USA

Ken Kleinman Harvard Medical School, Boston, Massachusetts, USA

Nicholas J. Horton Smith College, Northampton, Massachusetts, USA

“… a convenient reference text to quickly learn by example how to perform common tasks in both software packages. … the book provides a powerful starting point to a wide variety of statistical techniques available in SAS and R. … it facilitates a translation between SAS and R, without getting overly detailed or technical. … useful as a starting point for those who already know either R or SAS, and want to learn the other language, without going over extensive manuals or introductory texts.” —Journal of Statistical Software, January 2011, Vol. 37

Catalog no. C7057, 2010, 343 pp. ISBN: 978-1-4200-7057-6, $71.95 / £45.99

This book presents an easy way to learn how to perform an analytical task in R, without having to navigate through its extensive, idiosyncratic, and sometimes unwieldy software documentation and vast number of add-on packages. Showing how to efficiently use the powerful R system, the authors cover data management, descriptive summaries, inferential procedures, regression analysis, multivariate methods, and the creation of graphics. The text includes convenient indices organized by topic and R syntax. Data sets and code are available for download on the book’s website. Catalog no. K11360, January 2011, 297 pp. Soft Cover, ISBN: 978-1-4398-2755-0, $59.95 / £38.99 Also available as an eBook

Also available as an eBook

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Computational Biostatistics New!

Practical Statistical Methods

Coming soon!

A SAS Programming Approach

Analysis of Questionnaire Data with R

Lakshmi Padgett

Bruno Falissard

Centocor, Malvern, Pennsylvania, USA

This book presents a broad spectrum of statistical methods useful for researchers without an extensive statistical background. Omitting mathematical details and complicated formulae, it provides SAS programs to carry out the necessary analyses and draw appropriate inferences for common statistical problems. The author describes methods used for quantitative data and continuous data following normal and nonnormal distributions. She also focuses on simple linear regression, logistic regression, and the proportional hazards model. The final chapter briefly discusses propensity scores, misclassification errors, interim analysis, conditional power, bootstrap, and jackknife. Catalog no. K10634, April 2011, 304 pp. ISBN: 978-1-4398-1282-2, $79.95 / £49.99

INSERM U669, Paris, France

Addressing the problem of inefficient collection and analysis of questionnaire data, this book proposes a methodology that uses R software. The author takes a practical approach to the subject, presenting principles first followed by detailed examples of their application to real data. He discusses principles of good questionnaire design, data management, capture, and manipulation and covers descriptive statistics, scoring, reliability, and missing data. The book discusses the implementation of readily available R packages and integrates code throughout. All the data sets and R code packages are provided on a website. Catalog no. K10917, August 2011, c. 272 pp. ISBN: 978-1-4398-1766-7, $89.95 / £57.99

Also available as an eBook

Coming soon!

Bayesian Analysis Made Simple

A Handbook of Statistical Analyses using SAS Third Edition

An Excel GUI for WinBUGS

Geoff Der

Phil Woodward

Brian S. Everitt

Pfizer, LTD, Sandwich, Kent, UK

King’s College, University of London, UK

From simple NLMs to complex GLMMs, this book describes how to use the GUI for WinBUGS—BugsXLA—an Excel add-in written by the author that allows a range of Bayesian models to be easily specified. With case studies throughout, the text shows how to routinely apply even the more complex aspects of model specification, such as GLMMs, outlier robust models, random effects Emax models, auto-regressive errors, and Bayesian variable selection. It provides brief, up-to-date discussions of current issues in the practical application of Bayesian methods. The author also explains how to obtain free software to get started immediately.

“… The third edition of this handbook will prove to be an extremely useful reference tool for current and future SAS users.”

Catalog no. K11808, September 2011, c. 358 pp. ISBN: 978-1-4398-3954-6, $69.95 / £44.99

Catalog no. C7842, 2009, 392 pp. Soft Cover, ISBN: 978-1-58488-784-3, $59.95 / £37.99

University of Glasgow, Scotland

—Antonio Pinon, Journal of the Royal Statistical Society, Series A, 2010

“… this edition emphasizes how to conduct a range of statistical analyses using the latest version of SAS, version 9.2. … The Output Delivery System (ODS), the new graphic procedures, and ODS graphics can be used for presenting the results. … In summary, SAS users will find the new edition quite useful.” —Technometrics, November 2009, Vol. 51, No. 4

Also available as an eBook

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Computational Biostatistics

A Handbook of Statistical Analyses Using R Second Edition

Clinical Trials & Pharmaceutical Stats New!

Clinical Trial Methodology Karl E. Peace

Brian S. Everitt King’s College, University of London, UK

Jiann-Ping Hsu College of Public Health, Georgia Southern University, Statesboro, USA

Torsten Hothorn

Ding-Geng (Din) Chen

Ludwig-Maximilians-Universität München, Germany

University of Rochester Medical Center, New York, USA

“… an extensive selection of real data analyzed with [R] … Viewed as a collection of worked examples, this book has much to recommend it. Each chapter addresses a specific technique. … the examples provide a wide variety of partial analyses and the datasets cover a diversity of fields of study. … This handbook is unusually free of the sort of errors spell checkers do not find. …”

“The book is an excellent overview predicated on the first author’s seasoned experiences in designing, analyzing, and communicating the results of clinical trials across a broad number of medical disciplines. … The real-world examples that dominate the last few chapters are fantastic. … This book does an admirable job in giving the regulatory and statistical foundations for clinical trials, coupled with real-world examples of how statistical methodology has guided the development of important medicines. …”

—MAA Reviews, April 2011

Catalog no. C7933, 2010, 376 pp. Soft Cover, ISBN: 978-1-4200-7933-3, $57.95 / £36.99 Also available as an eBook

—Gregory Enas

Catalog no. C9179, January 2011, 420 pp. ISBN: 978-1-58488-917-5, $89.95 / £57.99 Also available as an eBook

Clinical Trials & Pharmaceutical Stats New!

Clinical Trial Data Analysis Using R

New!

Controversial Statistical Issues in Clinical Trials Shein-Chung Chow Duke University School of Medicine, Durham, North Carolina, USA

Written by one of the preeminent experts in the field, this book covers commonly encountered controversial statistical issues in clinical trials and, whenever possible, makes recommendations to resolve these problems. It focuses on issues occurring at various stages of clinical research and development, including early-phase clinical development, bench-to-bedside translational research, and latephase clinical development. Numerous examples illustrate the impact of these issues on the evaluation of the safety and efficacy of the test treatment under investigation. Catalog no. K12247, June 2011, 612 pp. ISBN: 978-1-4398-4961-3, $99.95 / £63.99

Ding-Geng (Din) Chen University of Rochester Medical Center, New York, USA

Karl E. Peace Jiann-Ping Hsu College of Public Health, Georgia Southern University, Statesboro, USA

This book thoroughly covers biostatistical analyses of clinical trial data and shows step by step how to implement the statistical methods using R. Each chapter presents examples of clinical trials based on the authors’ actual experiences in clinical drug development. Various biostatistical methods for analyzing the data are then identified. The authors also develop analysis code using appropriate R packages and functions. This approach enables readers to gain an understanding of the analysis methods and R implementation so that they can use R to analyze their own clinical trial data. Catalog no. K11861, January 2011, 387 pp. ISBN: 978-1-4398-4020-7, $89.95 / £57.99 Also available as an eBook

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Clinical Trials & Pharmaceutical Stats

New!

New!

Bayesian Adaptive Methods for Clinical Trials Scott M. Berry, Bradley P. Carlin, J. Jack Lee, and Peter Müller “… a rich introduction to Bayesian clinical trial design in general. It is written in an extremely readable style and is furnished with numerous examples and a great deal of helpful supplementary code. … a worthy addition to the practicing statistician’s library.” —Journal of Statistical Software, November 2010, Volume 37

“This fine book represents the most recent and exciting developments in this area and gives ample justification for the power and elegance of Bayesian trial design and analysis. … a major contribution to the science and practice of clinical trials.” —David J. Spiegelhalter, MRC Biostatistics Unit, University of Cambridge, UK

Catalog no. K11217, January 2011, 323 pp. ISBN: 978-1-4398-2548-8, $89.95 / £57.99

Dose Finding by the Continual Reassessment Method Ying Kuen Cheung Columbia University, New York, New York, USA

This book presents the continual reassessment method (CRM) as a tool for dose-finding studies. With a focus on the implementation and practice of the CRM and its variations, it explains how the CRM may be calibrated and extended to suit common clinical settings. The book includes examples of real clinical trials data to illustrate the calibration techniques and shows how R can be used to carry out the techniques. It reviews the literature, related methodology, and theoretical properties of the CRM. It also explores alternatives for situations where the CRM fails. Catalog no. C9151, March 2011, 200 pp. ISBN: 978-1-4200-9151-9, $79.95 / £49.99 Also available as an eBook

Also available as an eBook

New!

Monte Carlo Simulation for the Pharmaceutical Industry Concepts, Algorithms, and Case Studies

Design and Analysis of Quality of Life Studies in Clinical Trials Second Edition Diane L. Fairclough

Mark Chang AMAG Pharmaceuticals, Lexington, Massachusetts, USA

University of Colorado Health Sciences Center, Denver, USA

Helping you become a skillful “simulator,” this book provides broad coverage of the drug development process, from drug discovery to preclinical and clinical trial aspects to commercialization. It presents the theories and methods for carrying out computer simulations efficiently, covers both descriptive and pseudocode algorithms that provide the basis for implementing the simulation methods, and illustrates real-world problems through case studies. The author discusses game theory, adaptive design, molecular design, prescription drug marketing, biological pathway simulation, genetic programming, and pharmacokinetic modeling.

“… this book offers unique perspectives and insights that reflect decades of hands-on experience with HRQoL trials and that will certainly benefit researchers in this area. … Written clearly and concisely, the book is a pleasure to read. The technical level is reasonable for statistical practitioners and medical researchers with a good understanding of basic statistical concepts and methods. I would definitely recommend the book to researchers in HRQoL studies, and I think it is worth reading by anyone interested in clinical trials, because many of the issues discussed extend far beyond HRQoL studies.”

Catalog no. K11621, January 2011, 564 pp. ISBN: 978-1-4398-3592-0, $89.95 / £57.99 Also available as an eBook

—Statistics in Medicine, 2011, 30

Catalog no. C6117, 2010, 424 pp. ISBN: 978-1-4200-6117-8, $89.95 / £57.99 Also available as an eBook

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MBCBST1 MC_ISSUU:MBCBST1 MC 7/13/11 8:47 AM Page 9

Clinical Trials & Pharmaceutical Stats

Cluster Randomised Trials Richard J. Hayes London School of Hygiene & Tropical Medicine, UK

Lawrence H. Moulton

Sample Sizes for Clinical Trials

Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA

Steven A. Julious

“This comprehensive book covers all the main topics associated with design, conduct, and analysis of CRTs. … research-based examples aid understanding and bridge theory with practical applications. … I would highly recommend the book to all interested parties. …”

“…It is worth noting that the accumulation of references to the author’s published work in a multitude of journals as one reads through the text is demonstrative of the level of contributions he has made to the topic of this book. He clearly has a comprehensive knowledge of the literature that contributes to the body of knowledge in this area of methodology. … this is an extremely useful reference book that does not require a large investment of time to be able to put it to good use. …”

—Pharmaceutical Statistics, 2011

“… This is a well-written book which I definitely recommend, especially as a textbook for graduate or postgraduate level studies, or as a reference book for researchers working on the design or analysis of CRTs. …” —Journal of the Royal Statistical Society, Series A, Vol. 173, Issue 1, January 2010

Catalog no. C8164, 2009, 338 pp. ISBN: 978-1-58488-816-1, $92.95 / £56.99

University of Sheffield, UK

—Christopher A. Assaid, Journal of Biopharmaceutical Statistics, Issue 4, 2010

Catalog no. C7397, 2010, 317 pp. ISBN: 978-1-58488-739-3, $82.95 / £49.99 Also available as an eBook

Also available as an eBook

Data and Safety Monitoring Committees in Clinical Trials Jay Herson Johns Hopkins University, Baltimore, Maryland, USA

“… I highly recommend this book—not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC. …” —The American Statistician, November 2010, Vol. 64, No. 4

“…When searching for books about DSMCs, you will find that Ellenburg et al. (2002) published a book with an almost identical title to Herson’s. … overall I would recommend Herson’s book as more readable and detailed. …” —Andrea M. Rehman, Journal of the Royal Statistical Society, Series A, 2010

Catalog no. C7037, 2009, 191 pp. ISBN: 978-1-4200-7037-8, $89.95 / £57.99 Also available as an eBook

Sample Size Calculations in Clinical Research Second Edition Shein-Chung Chow, Hansheng Wang, and Jun Shao “… well written and easy to read … this book is recommended to biostatisticians and clinical scientists in medical or pharmaceutical research and provides a comprehensive reference of sample size calculations covering a wide range of different clinical research topics.” —Iris Burkholder, Zentralblatt MATH, 2009

“This impressive book contains formulae for computing sample size in a wide range of settings. … a useful reference for the mathematical statistician …” —Ian White, Journal of the Royal Statistical Society

Catalog no. C9829, 2008, 480 pp. ISBN: 978-1-58488-982-3, $89.95 / £60.99 Also available as an eBook

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Clinical Trials & Pharmaceutical Stats Coming soon!

Adaptive and Flexible Clinical Trials Richard Chin Institute for One World Health, San Francisco, California, USA

Unlike traditional fixed clinical trials that cannot be altered once the study begins, adaptive designs allow the study design to be modified in response to the data being generated in the course of the trial. The newly developed web-based real-time data entry and recent advances in statistical methods have made it possible to perform real-time, adaptive clinical trials. Suitable for readers in academia, industry, and government involved in drug development, this up-to-date, easy-to-read book covers the essential aspects of adaptive clinical trials. It discusses the design, conduct, and execution of these trials. Catalog no. K11738, August 2011, c. 196 pp. ISBN: 978-1-4398-3832-7, $89.95 / £57.99

Design and Analysis of Bioavailability and Bioequivalence Studies Third Edition Shein-Chung Chow Duke University School of Medicine, Durham, North Carolina, USA

Jen-pei Liu National Taiwan University, Taipei

“The text is well written and rich in all statistical methods … an important reference covering nearly all of the most relevant literature. Hence, it is a very valuable reference for anyone interested in the statistical aspects of bioequivalence.” —Journal of Biopharmaceutical Statistics, 2009

This third edition takes into account the regulatory and scientific developments that have occurred since the publication of its predecessor. It contains four new chapters, along with several new and updated sections. Catalog no. C6684, 2009, 760 pp. ISBN: 978-1-58488-668-6, $99.95 / £66.99 Also available as an eBook

New!

Handbook of Adaptive Designs in Pharmaceutical and Clinical Development

Multiple Testing Problems in Pharmaceutical Statistics

Edited by

Edited by

Annpey Pong

Alex Dmitrienko, Ajit C. Tamhane, and Frank Bretz

Merck Research Laboratories, Rahway, New Jersey, USA

Shein-Chung Chow Duke University School of Medicine, Durham, North Carolina, USA

This handbook provides a comprehensive and unified presentation of the principles and latest statistical methodologies used when modifying trial procedures based on accrued data of ongoing clinical trials. It also gives a well-balanced summary of current regulatory perspectives and presents real-world examples of a range of adaptive designs. Leading clinical researchers examine issues commonly encountered when applying adaptive design methods in clinical trials. They discuss the importance of sample size estimation/allocation, justification, and adjustment when implementing a complicated adaptive design. Catalog no. K10507, January 2011, 496 pp. ISBN: 978-1-4398-1016-3, $99.95 / £63.99

“If you are a statistician in the pharmaceutical industry looking for a comprehensive description of multiple testing in a clinical trial, this book is for you. … the book certainly attains its objective of being a modern summary of the approaches to multiplicity issues primarily in clinical trials, serving as an excellent guide for those who find themselves face to face with simultaneous testing and would like to have an overview over possible ways of tackling the problem. …” —Vera Lisovskaja and Carl-Fredrik Burman, Journal of Biopharmaceutical Statistics, Issue 6, 2010

Catalog no. C9845, 2010, 320 pp. ISBN: 978-1-58488-984-7, $89.95 / £57.99 Also available as an eBook

Also available as an eBook

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Clinical Trials & Pharmaceutical Stats

Survival Analysis New!

New!

Multiple Comparisons Using R Frank Bretz, Torsten Hothorn, and Peter Westfall “I found the book to be a rare gem … It is simply written, yet manages to explain the key concepts remarkably well. Above all, it introduces a comprehensible structure that unifies seemingly different methodologies into a single system. … I believe this book could be useful to all those seeking guidance [on] the multitude of multiplicity correcting procedures. … The authors managed to create a fine balance between theory and practical applications … The book is warmly recommended.” —Vera Lisovskaja, Journal of Biopharmaceutical Statistics, Vol. 21, 2011

Catalog no. C5742, January 2011, 205 pp. ISBN: 978-1-58488-574-0, $79.95 / £49.99

Flexible Parametric Survival Analysis Using Stata Beyond the Cox Model Patrick Royston University College London and MRC Clinical Trials Unit, UK

Paul C. Lambert University of Leicester, UK

Through real-world case studies, this book shows how to use Stata to estimate a class of flexible parametric survival models. It discusses the modeling of time-dependent and continuous covariates and looks at how relative survival can be used to measure mortality associated with a particular disease when the cause of death has not been recorded. The book describes simple quantification of differences between any two covariate patterns through calculation of time-dependent hazard ratios, hazard differences, and survival differences.

Also available as an eBook

Catalog no. N10372, July 2011, c. 339 pp. Soft Cover, ISBN: 978-1-59718-079-5, $79.95 / £49.99

Translational Medicine

New!

Strategies and Statistical Methods Edited by

An Introduction to Survival Analysis Using Stata

Dennis Cosmatos

Third Edition

Parexel International, Rydal, Pennsylvania, USA

Shein-Chung Chow Duke University School of Medicine, Durham, North Carolina, USA

This volume examines the critical decisions that must be made to successfully transition from basic to clinical science. Along with a review of existing processes, the book presents a detailed discussion of alternative research approaches that lead to faster and more accurate decisions on data. It provides insight on biomarker development in early phase clinical trials, integrates genomic and clinical databases for the establishment of medical predictive models in various diseases, and reviews the design and analysis for translating research findings. Catalog no. C8725, 2009, 224 pp. ISBN: 978-1-58488-872-7, $89.95 / £60.99 Also available as an eBook

Mario Cleves, William Gould, Roberto Gutierrez, and Yulia Marchenko This book provides the foundation to understand various approaches for analyzing time-to-event data. This third edition highlights new features of Stata 11, including competing-risks analysis and the treatment of missing values via multiple imputation. Other additions include new diagnostic measures after Cox regression, Stata’s new treatment of categorical variables and interactions, and a new syntax for obtaining prediction and diagnostics after Cox regression. The book helps you understand the formulas, gain intuition about how survival analysis estimators work and what information they exploit, and acquire deeper, more comprehensive knowledge of Stata’s survival analysis routines. Catalog no. N10331, January 2011, 412 pp. Soft Cover, ISBN: 978-1-59718-074-0, $79.95 / £49.99 Also available as an eBook

For more information and complete contents, visit www.crcpress.com

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Survival Analysis

New!

Frailty Models in Survival Analysis

Design and Analysis of Clinical Trials with Time-to-Event Endpoints Edited by

Karl E. Peace

Andreas Wienke Martin-Luther-University Halle-Wittenberg, Germany

Jiann-Ping Hsu College of Public Health, Georgia Southern University, Statesboro, USA

Accessible to nonspecialists, this book explains the basic ideas in frailty modeling and statistical techniques, with a focus on real data application and interpretation of the results. It extensively explores how univariate frailty models can represent unobserved heterogeneity. It also emphasizes correlated frailty models as extensions of univariate and shared frailty models. The author analyzes similarities and differences between frailty and copula models, discusses problems related to frailty models, and describes parametric and semiparametric models using both frequentist and Bayesian approaches. He also shows how to apply the models to real data using R, SAS, and Stata.

This resource provides a thorough presentation of the design, monitoring, analysis, and interpretation of clinical trials in which time-toevent is of critical interest. It discusses the design and monitoring of Phase II and III clinical trials with time-to-event endpoints. The book presents parametric, semiparametric, categorical, and Bayesian inferential and descriptive methods for analyzing time-to-event endpoints. It also covers numerous clinical trial applications, including analgesic, antibiotic, antiviral, cancer and cardiovascular prevention, optimal assignment of treatments, adverse events, and carcinogenicity.

Catalog no. C7388, January 2011, 312 pp. ISBN: 978-1-4200-7388-1, $99.95 / £63.99 Also available as an eBook

Catalog no. C6639, 2009, 616 pp. ISBN: 978-1-4200-6639-5, $99.95 / £63.99 Also available as an eBook

Epidemiology New!

New!

Modeling Survival Data Using Frailty Models

Statistical Thinking in Epidemiology

David D. Hanagal

University of Leeds, Leeds, UK

University of Pune, India

Frailty models have been introduced into the statistical literature to account for the existence of unmeasured attributes, such as genotypes that introduce heterogeneity into a study population. Including inference results, applications, and references, this book presents the basic concepts of frailty models in survival analysis. The author also addresses advanced topics in frailty models, including estimation procedures, tests for frailty, and additive frailty models. The text covers frailty models based on Levy processes as well as correlated frailty models.

This book provides new insights into the many existing problems in statistical modeling and offers several alternative strategies to approach these problems. Emphasizing the importance of statistical thinking behind all analyses, the authors use specific examples in epidemiology to illustrate different model specifications that can imply different sets of causal relationships between variables. Each model is interpreted with regard to the context of implicit or explicit causal relationships. The authors also use vector geometry where applicable to provide an intuitive understanding of important statistical concepts.

Catalog no. K11657, January 2011, 334 pp. ISBN: 978-1-4398-3667-5, $89.95 / £57.99

Catalog no. K10018, July 2011, c. 224 pp. ISBN: 978-1-4200-9991-1, $89.95 / £57.99

Yu-Kang Tu and Mark S Gilthorpe

Also available as an eBook

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For more information and complete contents, visit www.crcpress.com

MBCBST1 MC_ISSUU:MBCBST1 MC 7/13/11 8:47 AM Page 13

Epidemiology New!

Biosurveillance Methods and Case Studies Edited by

Taha Kass-Hout Atlanta, Georgia, USA

Bayesian Disease Mapping Hierarchical Modeling in Spatial Epidemiology Andrew Lawson

Xiaohui Zhang International Public Health Institute, Tucson, Arizona, USA

Medical University of South Carolina, Charleston, USA

This volume discusses how biosurveillance systems support epidemiologists and public health officials in the early identification, situational awareness, and response management of natural and man-made health-related events. Initial chapters build a foundation while subsequent chapters present applied case studies from around the world, including China, the United States, Denmark, and the Asia-Pacific region. Through these case studies, the expert contributors offer first-hand insight on lessons learned and unresolved issues. The book also addresses policy and organizational issues related to the construction of biosurveillance systems.

“This book provides a technical grounding in spatial models while maintaining a strong grasp on applied epidemiological problems. … A welcome effort is made to clarify concepts which might, in other texts, have been skimmed over in a rush to fit models. … the concepts are illustrated with disease mapping examples, including R and WinBUGS code. … The book has relatively few errors … I recommend the book. It taught me new ideas and clarified existing ones. …”

Catalog no. K10043, January 2011, 380 pp. ISBN: 978-1-4398-0046-1, $89.95 / £57.99

—Journal of the Royal Statistical Society, Series A, April 2011

Catalog no. C8407, 2009, 368 pp. ISBN: 978-1-58488-840-6, $85.95 / £54.99 Also available as an eBook

Also available as an eBook

Medical Diagnostics & Testing

Measurement Error

New!

Models, Methods, and Applications

Statistical Evaluation of Diagnostic Performance

John P. Buonaccorsi

Topics in ROC Analysis

University of Massachusetts, Amherst, USA

“This book is a successful attempt to collect, organize and present the literature over the newly developed and earlier existing topics of measurement error models in one place. … This book should be of immense help to those who are interested in the theoretical as well as applied aspects of measurement error models. … The book is overall well written, presents updated developments in the area of measurement error models and is an excellent guide to applications. I am sure that it will stimulate researchers in and newcomers to this area.” —Journal of the Royal Statistical Society, Series A, April 2011

Catalog no. C6656, 2010, 463 pp. ISBN: 978-1-4200-6656-2, $89.95 / £57.99

Kelly H. Zou, Aiyi Liu, Andriy. I Bandos, Lucila Ohno-Machado, and Howard E. Rockette This book presents innovative approaches in Receiver Operating Characteristic (ROC) analysis, which are relevant to a wide variety of applications, including medical imaging, cancer research, epidemiology, and bioinformatics. The covered topics include monotonetransformation techniques in parametric ROC analysis, ROC methods for combined and pooled biomarkers, Bayesian hierarchical transformation models, sequential designs and inferences in the ROC setting, predictive modeling, multireader ROC analysis, and free-response ROC (FROC) methodology. Catalog no. K10617, July 2011, c. 253 pp. ISBN: 978-1-4398-1222-8, $89.95 / £57.99

Also available as an eBook

For more information and complete contents, visit www.crcpress.com

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Medical Diagnostics & Testing

ROC Curves for Continuous Data Wojtek J. Krzanowski

Bayesian Methods for Measures of Agreement

University of Exeter, UK

Lyle D. Broemeling

David J. Hand

Broemeling and Associates, Medical Lake, Washington, USA

Imperial College, London, UK

“Drs. Krzanowski and Hand provide a thorough overview of ROC curve analysis, similar to books already available, but with a more comprehensive approach, including many recent advancements from the literature. … it covers not only application to medical testing but extends to other fields where ROC analysis can be very useful: geosciences, finance, psychology, and sociology. … this book is an excellent enhancement to the biostatistics literature. It will be a helpful reference not only for those in medicine but for researchers in all sectors…” —Journal of the American Statistical Association, Vol. 105, No. 492, December 2010

Catalog no. K10031, 2009, 232 pp. ISBN: 978-1-4398-0021-8, $71.95 / £45.99

“This book is a welcome addition to the literature on Bayesian inference as it presents methods for the design and analysis of agreement studies. … The approach presented by the author is novel and the novice will find a helpful introduction to Bayesian inference in an appendix. … The text is readable and will form a valuable reference source. For those unfamiliar with WinBUGS, the author introduces the fundamentals of programming and executing BUGS.” —International Statistical Review, 2010

Catalog no. C3414, 2009, 340 pp. ISBN: 978-1-4200-8341-5, $92.95 / £58.99 Also available as an eBook

Also available as an eBook

New! New!

Advanced Bayesian Methods for Medical Test Accuracy

Measures of Interobserver Agreement and Reliability Second Edition

Lyle D. Broemeling

Mohamed M. Shoukri

Broemeling and Associates, Medical Lake, Washington, USA

King Faisal Specialist Hospital & Research Centre, Riyadh, Saudi Arabia

This reference presents advanced techniques for assessing medical test accuracy. After reviewing specificity, sensitivity, positive predictive value, negative predictive value, and the area under the ROC curve, the book expands its scope to cover the more advanced topics of verification bias, diagnostic tests with imperfect gold standards, and medical tests where no gold standard is available. The author offers a practical treatment by including R and WinBUGS code in the examples and by employing the Bayesian approach throughout the text. He also provides practical problems at the end of each chapter.

Exploring applications in medical research and clinical epidemiology, this text continues to cover important issues related to the design and analysis of reliability and agreement studies. This edition contains a new chapter that describes various models for methods comparison studies as well as a new chapter on the analysis of reproducibility using the within-subjects coefficient of variation. It also emphasizes sample size determination and the definition of the subjects’ and raters’ population. The accompanying CD-ROM includes data sets and SAS code.

Catalog no. K11763, July 2011, c. 499 pp. ISBN: 978-1-4398-3878-5, $139.95 / £89.00

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Catalog no. K10539, January 2011, 291 pp. ISBN: 978-1-4398-1080-4, $99.95 / £63.99 Also available as an eBook

For more information and complete contents, visit www.crcpress.com

MBCBST1 MC_ISSUU:MBCBST1 MC 7/13/11 8:47 AM Page 15

Bioinformatics & Statistical Genetics

New!

Bayesian Modeling in Bioinformatics Edited by

Statistics in Human Genetics and Molecular Biology

Dipak K. Dey, Samiran Ghosh, and Bani K. Mallick

Cavan Reilly

This volume discusses the development and application of Bayesian statistical methods for the analysis of high-throughput bioinformatics data arising from problems in molecular and structural biology and disease-related medical research. It presents a broad overview of statistical inference, clustering, and classification problems in two main high-throughput platforms: microarray gene expression and phylogenic analysis. Illustrating concepts using real-world data, the book covers a variety of recently developed Bayesian techniques, along with applications in genome-wide studies, phylogenetics, breast cancer, expression genomics, and more.

With worked examples and end-of-chapter exercises, this book provides a basic understanding of problems arising in the analysis of genetics and genomics and presents statistical applications in genetic mapping, DNA/protein sequence alignment, and analyses of gene expression data from microarray experiments. It covers basic molecular biology, likelihood-based statistics, physical mapping, markers, linkage analysis, parametric and nonparametric linkage, sequence alignment, feature recognition, hidden Markov models, and Bayesian approaches. It also discusses differential gene expression detection as well as classification and cluster analysis using gene expression data sets.

Catalog no. C7017, January 2011, 466 pp. ISBN: 978-1-4200-7017-0, $89.95 / £57.99 Also available as an eBook

University of Minnesota, Minneapolis, USA

Catalog no. C7263, 2009, 280 pp. ISBN: 978-1-4200-7263-1, $61.95 / £39.99 Also available as an eBook

New!

Clustering in Bioinformatics and Drug Discovery John D. MacCuish and Norah E. MacCuish Mesa Analytics & Computing, Inc., Santa Fe, New Mexico, USA

“… Those of us who learned their clustering from Anderberg, Sokal and Sneath, and Willett now have a valuable additional resource suitable for the 21st century.” —John Bradshaw, Barley, Hertfordshire, UK

With a DVD of color figures, this book provides an expert guide on extracting the most pertinent information from pharmaceutical and biomedical data. It offers a concise overview of common and recent clustering methods used in bioinformatics and drug discovery. The authors include many real-world examples from industrial settings, such as combinatorial library design and compound databases. Catalog no. K10863, January 2011, 244 pp. ISBN: 978-1-4398-1678-3, $79.95 / £49.99

Statistical and Computational Pharmacogenomics Rongling Wu University of Florida, Gainesville, USA

Min Lin Duke Clinical Research Institute, Durham, North Carolina, USA

“… [Pharmacogenomics] can address questions such as whether individuals with different versions of a gene are more or less likely to respond to a particular drug. However, Wu and Lin go well beyond this and discuss methods for relating genetic variation to dynamic pharmacokinetic and pharmacodynamic profiles of drugs. … One of the main clinical applications of these methods will be in predicting efficacy and toxicity of drugs, allowing treatment to be tailored to an individual’s genetic background, and this book makes a valuable contribution towards this.” —Significance, June 2010

Catalog no. C8288, 2009, 368 pp. ISBN: 978-1-58488-828-4, $85.95 / £54.99 Also available as an eBook

Also available as an eBook

For more information and complete contents, visit www.crcpress.com

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A Call for Authors A Series from Chapman & Hall/CRC

Biostatistics Aims and Scope: The primary objectives of the Chapman & Hall/CRC Biostatistics Series are to provide useful reference books for researchers and scientists in academia, industry, and government and to offer textbooks for undergraduate and graduate courses in the areas of biostatistics and bioinformatics. The book series will provide comprehensive and unified presentations of statistical designs and analyses of important applications in biostatistics and bioinformatics, such as those in biological and biomedical research. The scope of the series is wide, including applications of statistical methodology in biology, epidemiology, genetics, pharmaceutical science and clinical trials, public health, and medicine. The series is committed to providing easy-tounderstand, state-of-the-art references and textbooks. In each volume, statistical concepts and methodologies will be illustrated through real-world examples whenever possible.

Editor-in-Chief

Series Editors

Shein-Chung Chow

Byron Jones

Karl E. Peace

Duke University School of Medicine

Pfizer Global Research & Development

Georgia Southern University

sheinchung.chow@duke.edu

byron.jones@pfizer.com

kepeace@georgiasouthern.edu

Jen-pei Liu

Bruce W. Turnbull

National Taiwan University

Cornell University

jpliu@ntu.edu.tw

bwt2@cornell.edu

Proposals for the series should be submitted to one of the series editors above or directly to:

David Grubbs Acquisitions Editor

Chapman & Hall/CRC Press, Taylor & Francis Group 6000 Broken Sound Pkwy NW, Suite 300 Boca Raton, FL 33487 Tel: 561-361-6000 ext. 2524 Email: david.grubbs@taylorandfrancis.com

Forthcoming

Design and Analysis of Non-Inferiority Trials Mark D. Rothmann, Brian L. Wiens, and Ivan S.F. Chan This book confronts the issues involved in the design of non-inferiority trials. Using examples from real clinical trials, it discusses general and regulatory issues and illustrates how they affect analysis. Each chapter includes a non-technical introduction and also provides detailed mathematical approaches along with their mathematical properties. Catalog no. C8040, July 2011, c. 464 pp., ISBN: 978-1-58488-804-8, $89.95 / ÂŁ57.99

For more information and a complete contents, visit www.crcpress.com

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