Cluster Randomised Trials Second Edition Editor-in-Chief Shein-Chung Chow, Ph.D., Professor, Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina 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 Basic Statistics and Pharmaceutical Trials, Second Edition Statistical Applications, Second Edition Shein-Chung Chow and Mark Chang James E. De Muth Adaptive Designs for Sequential Bayesian Adaptive Methods for Treatment Allocation Clinical Trials Alessandro Baldi Antognini Scott M. Berry, Bradley P. Carlin, and Alessandra Giovagnoli J. Jack Lee, and Peter Muller Adaptive Design Theory and Bayesian Analysis Made Simple: Implementation Using SAS and R, An Excel GUI for WinBUGS Second Edition Phil Woodward Mark Chang Bayesian Designs for Phase I–II Advanced Bayesian Methods for Clinical Trials Medical Test Accuracy Ying Yuan, Hoang Q. Nguyen, Lyle D. Broemeling and Peter F. Thall Analyzing Longitudinal Clinical Trial Data: Bayesian Methods for Measures A Practical Guide of Agreement Craig Mallinckrodt and Ilya Lipkovich Lyle D. Broemeling Applied Biclustering Methods for Big Bayesian Methods for Repeated Measures and High-Dimensional Data Using R Lyle D. Broemeling Adetayo Kasim, Ziv Shkedy, Bayesian Methods in Epidemiology Sebastian Kaiser, Sepp Hochreiter, Lyle D. Broemeling and Willem Talloen Bayesian Methods in Health Economics Applied Meta-Analysis with R Gianluca Baio Ding-Geng (Din) Chen and Karl E. Peace Bayesian Missing Data Problems: EM, Applied Surrogate Endpoint Evaluation Data Augmentation and Noniterative Methods with SAS and R Computation Ariel Alonso, Theophile Bigirumurame, Ming T. Tan, Guo-Liang Tian, Tomasz Burzykowski, Marc Buyse, and Kai Wang Ng Geert Molenberghs, Leacky Muchene, Nolen Joy Perualila, Ziv Shkedy, and Wim Van der Elst Published Titles Bayesian Modeling in Bioinformatics Dipak K. Dey, Samiran Ghosh, and Bani K. Mallick Clinical Trial Optimization Using R Benefit-Risk Assessment in Alex Dmitrienko and Erik Pulkstenis Pharmaceutical Research and Cluster Randomised Trials: Development Second Edition Andreas Sashegyi, James Felli, Richard J. Hayes and Lawrence H. Moulton and Rebecca Noel Computational Methods in Biomedical Benefit-Risk Assessment Methods in Research Medical Product Development: Bridging Ravindra Khattree and Dayanand N. Naik Qualitative and Quantitative Assessments Qi Jiang and Weili He Computational Pharmacokinetics Anders Källén Bioequivalence and Statistics in Clinical Pharmacology, Second Edition Confidence Intervals for Proportions Scott Patterson and Byron Jones and Related Measures of Effect Size Robert G. Newcombe Biosimilar Clinical Development: Scientific Considerations and New Controversial Statistical Issues in Methodologies Clinical Trials Kerry B. Barker, Sandeep M. Menon, Shein-Chung Chow Ralph B. D’Agostino, Sr., Siyan Xu, and Bo Jin Data Analysis with Competing Risks Biosimilars: Design and Analysis of and Intermediate States Follow-on Biologics Ronald B. Geskus Shein-Chung Chow Data and Safety Monitoring Committees Biostatistics: A Computing Approach in Clinical Trials, Second Edition Stewart J. Anderson Jay Herson Cancer Clinical Trials: Current and Design and Analysis of Animal Studies Controversial Issues in Design and in Pharmaceutical Development Analysis Shein-Chung Chow and Jen-pei Liu Stephen L. George, Xiaofei Wang, Design and Analysis of Bioavailability and Herbert Pang and Bioequivalence Studies, Third Edition Causal Analysis in Biomedicine and Shein-Chung Chow and Jen-pei Liu Epidemiology: Based on Minimal Design and Analysis of Bridging Studies Sufficient Causation Jen-pei Liu, Shein-Chung Chow, Mikel Aickin and Chin-Fu Hsiao Clinical and Statistical Considerations in Design & Analysis of Clinical Trials for Personalized Medicine Economic Evaluation & Reimbursement: Claudio Carini, Sandeep Menon, and Mark Chang An Applied Approach Using SAS & STATA Clinical Trial Data Analysis Using R Iftekhar Khan Ding-Geng (Din) Chen and Karl E. Peace Design and Analysis of Clinical Trials Clinical Trial Data Analysis Using R and SAS, for Predictive Medicine Second Edition Shigeyuki Matsui, Marc Buyse, Ding-Geng (Din) Chen, Karl E. Peace, and Richard Simon and Pinggao Zhang Design and Analysis of Clinical Trials with Clinical Trial Methodology Time-to-Event Endpoints Karl E. Peace and Ding-Geng (Din) Chen Karl E. Peace Published Titles Design and Analysis of Non-Inferiority Trials Handbook of Regression and Modeling: Mark D. Rothmann, Brian L. Wiens, Applications for the Clinical and and Ivan S. F. Chan Pharmaceutical Industries Daryl S. Paulson Difference Equations with Public Health Applications Inference Principles for Biostatisticians Lemuel A. Moyé and Asha Seth Kapadia Ian C. Marschner DNA Methylation Microarrays: Interval-Censored Time-to-Event Data: Experimental Design and Statistical Methods and Applications Analysis Ding-Geng (Din) Chen, Jianguo Sun, Sun-Chong Wang and Arturas Petronis and Karl E. Peace DNA Microarrays and Related Genomics Introductory Adaptive Trial Designs: Techniques: Design, Analysis, and A Practical Guide with R Interpretation of Experiments Mark Chang David B. Allison, Grier P. Page, Joint Models for Longitudinal and Time- T. Mark Beasley, and Jode W. Edwards to-Event Data: With Applications in R Dose Finding by the Continual Dimitris Rizopoulos Reassessment Method Measures of Interobserver Agreement Ying Kuen Cheung and Reliability, Second Edition Dynamical Biostatistical Models Mohamed M. Shoukri Daniel Commenges and Medical Biostatistics, Third Edition Hélène Jacqmin-Gadda A. Indrayan Elementary Bayesian Biostatistics Meta-Analysis in Medicine and Lemuel A. Moyé Health Policy Emerging Non-Clinical Biostatistics in Dalene Stangl and Donald A. Berry Biopharmaceutical Development and Methods in Comparative Effectiveness Manufacturing Research Harry Yang Constantine Gatsonis and Sally C. Morton Empirical Likelihood Method in Mixed Effects Models for the Population Survival Analysis Approach: Models, Tasks, Methods Mai Zhou and Tools Essentials of a Successful Biostatistical Marc Lavielle Collaboration Modeling to Inform Infectious Disease Arul Earnest Control Exposure–Response Modeling: Methods Niels G. Becker and Practical Implementation Modern Adaptive Randomized Clinical Jixian Wang Trials: Statistical and Practical Aspects Frailty Models in Survival Analysis Oleksandr Sverdlov Andreas Wienke Monte Carlo Simulation for the Fundamental Concepts for New Clinical Pharmaceutical Industry: Concepts, Trialists Algorithms, and Case Studies Scott Evans and Naitee Ting Mark Chang Generalized Linear Models: A Bayesian Multiregional Clinical Trials for Perspective Simultaneous Global New Drug Dipak K. Dey, Sujit K. Ghosh, and Development Bani K. Mallick Joshua Chen and Hui Quan Published Titles Multiple Testing Problems in Statistical Design and Analysis of Clinical Pharmaceutical Statistics Trials: Principles and Methods Alex Dmitrienko, Ajit C. Tamhane, Weichung Joe Shih and Joseph Aisner and Frank Bretz Statistical Design and Analysis of Noninferiority Testing in Clinical Trials: Stability Studies Issues and Challenges Shein-Chung Chow Tie-Hua Ng Statistical Evaluation of Diagnostic Optimal Design for Nonlinear Response Performance: Topics in ROC Analysis Models Kelly H. Zou, Aiyi Liu, Andriy Bandos, Valerii V. Fedorov and Sergei L. Leonov Lucila Ohno-Machado, and Howard Rockette Patient-Reported Outcomes: Statistical Methods for Clinical Trials Measurement, Implementation and Mark X. Norleans Interpretation Statistical Methods for Drug Safety Joseph C. Cappelleri, Kelly H. Zou, Robert D. Gibbons and Anup K. Amatya Andrew G. Bushmakin, Jose Ma. J. Alvir, Statistical Methods for Healthcare Demissie Alemayehu, and Tara Symonds Performance Monitoring Quantitative Evaluation of Safety in Drug Alex Bottle and Paul Aylin Development: Design, Analysis and Statistical Methods for Immunogenicity Reporting Assessment Qi Jiang and H. Amy Xia Harry Yang, Jianchun Zhang, Binbing Yu, Quantitative Methods for Traditional and Wei Zhao Chinese Medicine Development Statistical Methods in Drug Combination Shein-Chung Chow Studies Randomized Clinical Trials of Wei Zhao and Harry Yang Nonpharmacological Treatments Statistical Testing Strategies in the Isabelle Boutron, Philippe Ravaud, Health Sciences and David Moher Albert Vexler, Alan D. Hutson, Randomized Phase II Cancer and Xiwei Chen Clinical Trials Statistics in Drug Research: Sin-Ho Jung Methodologies and Recent Repeated Measures Design with Developments Generalized Linear Mixed Models for Shein-Chung Chow and Jun Shao Randomized Controlled Trials Statistics in the Pharmaceutical Industry, Toshiro Tango Third Edition Sample Size Calculations for Clustered Ralph Buncher and Jia-Yeong Tsay and Longitudinal Outcomes in Clinical Survival Analysis in Medicine and Research Genetics Chul Ahn, Moonseong Heo, Jialiang Li and Shuangge Ma and Song Zhang Theory of Drug Development Sample Size Calculations in Clinical Eric B. Holmgren Research, Second Edition Shein-Chung Chow, Jun Shao, Translational Medicine: Strategies and and Hansheng Wang Statistical Methods Dennis Cosmatos and Shein-Chung Chow Statistical Analysis of Human Growth and Development Yin Bun Cheung Cluster Randomised Trials Second Edition By Richard J. Hayes Lawrence H. Moulton Cover image from SHINE Trial Team. The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial: Rationale, design, and methods. Clinical Infectious Diseases 61(suppl 7):S685–702; 2015, under the Creative Commons license. CRC Press Taylor & Francis Group 6000 Broken Sound Parkway NW, Suite 300 Boca Raton, FL 33487-2742 © 2017 by Taylor & Francis Group, LLC CRC Press is an imprint of Taylor & Francis Group, an Informa business No claim to original U.S. Government works Printed on acid-free paper International Standard Book Number-13: 978-1-4987-2822-5 (Hardback) This book contains information obtained from authentic and highly regarded sources. Reasonable efforts have been made to publish reliable data and information, but the author and publisher cannot assume responsibility for the validity of all materials or the consequences of their use. 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