, Statistical Topics in
Health Economics and
Outcomes Research
,Editor-in-Chief
Shein-Chung Chow, Ph.D., Associate Director, Office of Biostatistics, CDER/FDA,
Silver Springs, Maryland
Series Editors
Byron Jones, Biometrical Fellow, Statistical Methodology, Integrated Information Sciences,
Novartis Pharma AG, Basel, Switzerland
Jen-pei Liu, Professor, Division of Biometry, Department of Agronomy,
National Taiwan University, Taipei, Taiwan
Karl E. Peace, Georgia Cancer Coalition, Distinguished Cancer Scholar, Senior Research Scientist
and Professor of Biostatistics, Jiann-Ping Hsu College of Public Health,
Georgia Southern University, Statesboro, Georgia
Bruce W. Turnbull, Professor, School of Operations Research and Industrial Engineering,
Cornell University, Ithaca, New York
Published Titles
Adaptive Design Methods in Clinical Trials, Bayesian Methods for Measures of Agreement
Second Edition Lyle D. Broemeling
Shein-Chung Chow and Mark Chang
Bayesian Methods for Repeated Measures
Adaptive Designs for Sequential Treatment Allocation Lyle D. Broemeling
Alessandro Baldi Antognini and Alessandra Giovagnoli
Bayesian Methods in Epidemiology
Adaptive Design Theory and Implementation Using Lyle D. Broemeling
SAS and R, Second Edition
Bayesian Methods in Health Economics
Mark Chang
Gianluca Baio
Advanced Bayesian Methods for
Bayesian Missing Data Problems: EM, Data
Medical Test Accuracy
Augmentation and Noniterative Computation
Lyle D. Broemeling
Ming T. Tan, Guo-Liang Tian, and Kai Wang Ng
Analyzing Longitudinal Clinical Trial Data:
Bayesian Modeling in Bioinformatics
A Practical Guide
Dipak K. Dey, Samiran Ghosh, and Bani K. Mallick
Craig Mallinckrodt and Ilya Lipkovich
Benefit-Risk Assessment in Pharmaceutical
Applied Biclustering Methods for Big
Research and Development
and High-Dimensional Data Using R
Andreas Sashegyi, James Felli, and Rebecca Noel
Adetayo Kasim, Ziv Shkedy, Sebastian Kaiser,
Sepp Hochreiter, and Willem Talloen Benefit-Risk Assessment Methods in Medical
Product Development: Bridging Qualitative and
Applied Meta-Analysis with R
Quantitative Assessments
Ding-Geng (Din) Chen and Karl E. Peace
Qi Jiang and Weili He
Applied Surrogate Endpoint Evaluation Methods
Bioequivalence and Statistics in Clinical
with SAS and R
Pharmacology, Second Edition
Ariel Alonso, Theophile Bigirumurame,
Scott Patterson and Byron Jones
Tomasz Burzykowski, Marc Buyse, Geert Molenberghs,
Leacky Muchene, Nolen Joy Perualila, Ziv Shkedy, Biosimilar Clinical Development: Scientific
and Wim Van der Elst Considerations and New Methodologies
Kerry B. Barker, Sandeep M. Menon, Ralph B.
Basic Statistics and Pharmaceutical Statistical
D’Agostino, Sr., Siyan Xu, and Bo Jin
Applications, Second Edition
James E. De Muth Biosimilars: Design and Analysis of Follow-on
Biologics
Bayesian Adaptive Methods for
Shein-Chung Chow
Clinical Trials
Scott M. Berry, Bradley P. Carlin, J. Jack Lee, Biostatistics: A Computing Approach
and Peter Muller Stewart J. Anderson
Bayesian Analysis Made Simple: Cancer Clinical Trials: Current and Controversial
An Excel GUI for WinBUGS Issues in Design and Analysis
Phil Woodward Stephen L. George, Xiaofei Wang, and Herbert Pang
Bayesian Designs for Phase I–II Causal Analysis in Biomedicine and Epidemiology:
Clinical Trials Based on Minimal Sufficient Causation
Ying Yuan, Hoang Q. Nguyen, and Peter F. Thall Mikel Aickin
, Published Titles
Clinical and Statistical Considerations in DNA Microarrays and Related Genomics Techniques:
Personalized Medicine Design, Analysis, and Interpretation of Experiments
Claudio Carini, Sandeep Menon, and Mark Chang David B. Allison, Grier P. Page, T. Mark Beasley,
and Jode W. Edwards
Clinical Trial Data Analysis Using R
Ding-Geng (Din) Chen and Karl E. Peace Dose Finding by the Continual Reassessment Method
Ying Kuen Cheung
Clinical Trial Data Analysis Using R and SAS,
Second Edition Dynamical Biostatistical Models
Ding-Geng (Din) Chen, Karl E. Peace, Daniel Commenges and Hélène Jacqmin-Gadda
and Pinggao Zhang
Elementary Bayesian Biostatistics
Clinical Trial Methodology Lemuel A. Moyé
Karl E. Peace and Ding-Geng (Din) Chen
Emerging Non-Clinical Biostatistics in
Clinical Trial Optimization Using R Biopharmaceutical Development and Manufacturing
Alex Dmitrienko and Erik Pulkstenis Harry Yang
Cluster Randomised Trials: Second Edition Empirical Likelihood Method in Survival Analysis
Richard J. Hayes and Lawrence H. Moulton Mai Zhou
Computational Methods in Biomedical Research Essentials of a Successful Biostatistical
Ravindra Khattree and Dayanand N. Naik Collaboration
Arul Earnest
Computational Pharmacokinetics
Anders Källén Exposure–Response Modeling: Methods and
Practical Implementation
Confidence Intervals for Proportions and Related
Jixian Wang
Measures of Effect Size
Robert G. Newcombe Frailty Models in Survival Analysis
Andreas Wienke
Controversial Statistical Issues in Clinical Trials
Shein-Chung Chow Fundamental Concepts for New Clinical Trialists
Scott Evans and Naitee Ting
Data Analysis with Competing Risks and
Intermediate States Generalized Linear Models: A Bayesian Perspective
Ronald B. Geskus Dipak K. Dey, Sujit K. Ghosh, and Bani K. Mallick
Data and Safety Monitoring Committees in Handbook of Regression and Modeling: Applications
Clinical Trials, Second Edition for the Clinical and Pharmaceutical Industries
Jay Herson Daryl S. Paulson
Design and Analysis of Animal Studies Inference Principles for Biostatisticians
in Pharmaceutical Development Ian C. Marschner
Shein-Chung Chow and Jen-pei Liu
Interval-Censored Time-to-Event Data: Methods and
Design and Analysis of Bioavailability Applications
and Bioequivalence Studies, Third Edition Ding-Geng (Din) Chen, Jianguo Sun, and Karl E. Peace
Shein-Chung Chow and Jen-pei Liu
Introductory Adaptive Trial Designs: A Practical
Design and Analysis of Bridging Studies Guide with R
Jen-pei Liu, Shein-Chung Chow, and Chin-Fu Hsiao Mark Chang
Design & Analysis of Clinical Trials for Economic Joint Models for Longitudinal and Time-to-Event
Evaluation & Reimbursement: An Applied Approach Data: With Applications in R
Using SAS & STATA Dimitris Rizopoulos
Iftekhar Khan
Measures of Interobserver Agreement and Reliability,
Design and Analysis of Clinical Trials for Predictive Second Edition
Medicine Mohamed M. Shoukri
Shigeyuki Matsui, Marc Buyse, and Richard Simon
Medical Biostatistics, Fourth Edition
Design and Analysis of Clinical Trials with Time-to- A. Indrayan
Event Endpoints
Meta-Analysis in Medicine and Health Policy
Karl E. Peace
Dalene Stangl and Donald A. Berry
Design and Analysis of Non-Inferiority Trials
Methods in Comparative Effectiveness Research
Mark D. Rothmann, Brian L. Wiens, and Ivan S. F. Chan
Constantine Gatsonis and Sally C. Morton
Difference Equations with Public Health Applications
Mixed Effects Models for the Population Approach:
Lemuel A. Moyé and Asha Seth Kapadia
Models, Tasks, Methods and Tools
DNA Methylation Microarrays: Experimental Design Marc Lavielle
and Statistical Analysis
Modeling to Inform Infectious Disease Control
Sun-Chong Wang and Arturas Petronis
Niels G. Becker
Health Economics and
Outcomes Research
,Editor-in-Chief
Shein-Chung Chow, Ph.D., Associate Director, Office of Biostatistics, CDER/FDA,
Silver Springs, Maryland
Series Editors
Byron Jones, Biometrical Fellow, Statistical Methodology, Integrated Information Sciences,
Novartis Pharma AG, Basel, Switzerland
Jen-pei Liu, Professor, Division of Biometry, Department of Agronomy,
National Taiwan University, Taipei, Taiwan
Karl E. Peace, Georgia Cancer Coalition, Distinguished Cancer Scholar, Senior Research Scientist
and Professor of Biostatistics, Jiann-Ping Hsu College of Public Health,
Georgia Southern University, Statesboro, Georgia
Bruce W. Turnbull, Professor, School of Operations Research and Industrial Engineering,
Cornell University, Ithaca, New York
Published Titles
Adaptive Design Methods in Clinical Trials, Bayesian Methods for Measures of Agreement
Second Edition Lyle D. Broemeling
Shein-Chung Chow and Mark Chang
Bayesian Methods for Repeated Measures
Adaptive Designs for Sequential Treatment Allocation Lyle D. Broemeling
Alessandro Baldi Antognini and Alessandra Giovagnoli
Bayesian Methods in Epidemiology
Adaptive Design Theory and Implementation Using Lyle D. Broemeling
SAS and R, Second Edition
Bayesian Methods in Health Economics
Mark Chang
Gianluca Baio
Advanced Bayesian Methods for
Bayesian Missing Data Problems: EM, Data
Medical Test Accuracy
Augmentation and Noniterative Computation
Lyle D. Broemeling
Ming T. Tan, Guo-Liang Tian, and Kai Wang Ng
Analyzing Longitudinal Clinical Trial Data:
Bayesian Modeling in Bioinformatics
A Practical Guide
Dipak K. Dey, Samiran Ghosh, and Bani K. Mallick
Craig Mallinckrodt and Ilya Lipkovich
Benefit-Risk Assessment in Pharmaceutical
Applied Biclustering Methods for Big
Research and Development
and High-Dimensional Data Using R
Andreas Sashegyi, James Felli, and Rebecca Noel
Adetayo Kasim, Ziv Shkedy, Sebastian Kaiser,
Sepp Hochreiter, and Willem Talloen Benefit-Risk Assessment Methods in Medical
Product Development: Bridging Qualitative and
Applied Meta-Analysis with R
Quantitative Assessments
Ding-Geng (Din) Chen and Karl E. Peace
Qi Jiang and Weili He
Applied Surrogate Endpoint Evaluation Methods
Bioequivalence and Statistics in Clinical
with SAS and R
Pharmacology, Second Edition
Ariel Alonso, Theophile Bigirumurame,
Scott Patterson and Byron Jones
Tomasz Burzykowski, Marc Buyse, Geert Molenberghs,
Leacky Muchene, Nolen Joy Perualila, Ziv Shkedy, Biosimilar Clinical Development: Scientific
and Wim Van der Elst Considerations and New Methodologies
Kerry B. Barker, Sandeep M. Menon, Ralph B.
Basic Statistics and Pharmaceutical Statistical
D’Agostino, Sr., Siyan Xu, and Bo Jin
Applications, Second Edition
James E. De Muth Biosimilars: Design and Analysis of Follow-on
Biologics
Bayesian Adaptive Methods for
Shein-Chung Chow
Clinical Trials
Scott M. Berry, Bradley P. Carlin, J. Jack Lee, Biostatistics: A Computing Approach
and Peter Muller Stewart J. Anderson
Bayesian Analysis Made Simple: Cancer Clinical Trials: Current and Controversial
An Excel GUI for WinBUGS Issues in Design and Analysis
Phil Woodward Stephen L. George, Xiaofei Wang, and Herbert Pang
Bayesian Designs for Phase I–II Causal Analysis in Biomedicine and Epidemiology:
Clinical Trials Based on Minimal Sufficient Causation
Ying Yuan, Hoang Q. Nguyen, and Peter F. Thall Mikel Aickin
, Published Titles
Clinical and Statistical Considerations in DNA Microarrays and Related Genomics Techniques:
Personalized Medicine Design, Analysis, and Interpretation of Experiments
Claudio Carini, Sandeep Menon, and Mark Chang David B. Allison, Grier P. Page, T. Mark Beasley,
and Jode W. Edwards
Clinical Trial Data Analysis Using R
Ding-Geng (Din) Chen and Karl E. Peace Dose Finding by the Continual Reassessment Method
Ying Kuen Cheung
Clinical Trial Data Analysis Using R and SAS,
Second Edition Dynamical Biostatistical Models
Ding-Geng (Din) Chen, Karl E. Peace, Daniel Commenges and Hélène Jacqmin-Gadda
and Pinggao Zhang
Elementary Bayesian Biostatistics
Clinical Trial Methodology Lemuel A. Moyé
Karl E. Peace and Ding-Geng (Din) Chen
Emerging Non-Clinical Biostatistics in
Clinical Trial Optimization Using R Biopharmaceutical Development and Manufacturing
Alex Dmitrienko and Erik Pulkstenis Harry Yang
Cluster Randomised Trials: Second Edition Empirical Likelihood Method in Survival Analysis
Richard J. Hayes and Lawrence H. Moulton Mai Zhou
Computational Methods in Biomedical Research Essentials of a Successful Biostatistical
Ravindra Khattree and Dayanand N. Naik Collaboration
Arul Earnest
Computational Pharmacokinetics
Anders Källén Exposure–Response Modeling: Methods and
Practical Implementation
Confidence Intervals for Proportions and Related
Jixian Wang
Measures of Effect Size
Robert G. Newcombe Frailty Models in Survival Analysis
Andreas Wienke
Controversial Statistical Issues in Clinical Trials
Shein-Chung Chow Fundamental Concepts for New Clinical Trialists
Scott Evans and Naitee Ting
Data Analysis with Competing Risks and
Intermediate States Generalized Linear Models: A Bayesian Perspective
Ronald B. Geskus Dipak K. Dey, Sujit K. Ghosh, and Bani K. Mallick
Data and Safety Monitoring Committees in Handbook of Regression and Modeling: Applications
Clinical Trials, Second Edition for the Clinical and Pharmaceutical Industries
Jay Herson Daryl S. Paulson
Design and Analysis of Animal Studies Inference Principles for Biostatisticians
in Pharmaceutical Development Ian C. Marschner
Shein-Chung Chow and Jen-pei Liu
Interval-Censored Time-to-Event Data: Methods and
Design and Analysis of Bioavailability Applications
and Bioequivalence Studies, Third Edition Ding-Geng (Din) Chen, Jianguo Sun, and Karl E. Peace
Shein-Chung Chow and Jen-pei Liu
Introductory Adaptive Trial Designs: A Practical
Design and Analysis of Bridging Studies Guide with R
Jen-pei Liu, Shein-Chung Chow, and Chin-Fu Hsiao Mark Chang
Design & Analysis of Clinical Trials for Economic Joint Models for Longitudinal and Time-to-Event
Evaluation & Reimbursement: An Applied Approach Data: With Applications in R
Using SAS & STATA Dimitris Rizopoulos
Iftekhar Khan
Measures of Interobserver Agreement and Reliability,
Design and Analysis of Clinical Trials for Predictive Second Edition
Medicine Mohamed M. Shoukri
Shigeyuki Matsui, Marc Buyse, and Richard Simon
Medical Biostatistics, Fourth Edition
Design and Analysis of Clinical Trials with Time-to- A. Indrayan
Event Endpoints
Meta-Analysis in Medicine and Health Policy
Karl E. Peace
Dalene Stangl and Donald A. Berry
Design and Analysis of Non-Inferiority Trials
Methods in Comparative Effectiveness Research
Mark D. Rothmann, Brian L. Wiens, and Ivan S. F. Chan
Constantine Gatsonis and Sally C. Morton
Difference Equations with Public Health Applications
Mixed Effects Models for the Population Approach:
Lemuel A. Moyé and Asha Seth Kapadia
Models, Tasks, Methods and Tools
DNA Methylation Microarrays: Experimental Design Marc Lavielle
and Statistical Analysis
Modeling to Inform Infectious Disease Control
Sun-Chong Wang and Arturas Petronis
Niels G. Becker
