Table Of ContentCluster 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.
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Library of Congress Cataloging‑ in‑ Publication Data
Names: Hayes, Richard J., 1953- | Moulton, Lawrence H.
Title: Cluster randomised trials / Richard J. Hayes, Lawrence H. Moulton.
Description: Second edition. | Boca Raton : CRC Press, [2017] | Series:
Chapman & hall/crc biostatistics series | Includes bibliographical
references and index.
Identifiers: LCCN 2016057960| ISBN 9781498728225 (hardback) | ISBN
9781315370286 (e-book) | ISBN 9781498728232 (adobe reader) | ISBN
9781315353234 (e-pub) | ISBN 9781315334172 (mobipocket)
Subjects: LCSH: Clinical trials. | Cluster analysis.
Classification: LCC R853.C55 H39 2017 | DDC 610.72/4--dc23
LC record available at https://lccn.loc.gov/2016057960
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