Data and Safety Monitoring Committees in Clinical Trials

218 Pages·2016·1.68 MB·English

by  Jay Herson

Data and
Safety Monitoring
Committees
in Clinical Trials
Second Edition
Published Titles
Editor-in-Chief Bayesian Modeling in Bioinformatics Computational Pharmacokinetics
Shein-Chung Chow, Ph.D., Professor, Department of Biostatistics and Bioinformatics, Dipak K. Dey, Samiran Ghosh, Anders Källén
Duke University School of Medicine, Durham, North Carolina and Bani K. Mallick
Confidence Intervals for Proportions
Benefit-Risk Assessment in and Related Measures of Effect Size
Series Editors
Pharmaceutical Research and Robert G. Newcombe
Byron Jones, Biometrical Fellow, Statistical Methodology, Integrated Information Sciences,
Development
Novartis Pharma AG, Basel, Switzerland Controversial Statistical Issues in
Andreas Sashegyi, James Felli,
Clinical Trials
Jen-pei Liu, Professor, Division of Biometry, Department of Agronomy,
and Rebecca Noel
Shein-Chung Chow
National Taiwan University, Taipei, Taiwan
Benefit-Risk Assessment Methods in
Karl E. Peace, Georgia Cancer Coalition, Distinguished Cancer Scholar, Senior Research Scientist Data Analysis with Competing Risks
Medical Product Development: Bridging
and Professor of Biostatistics, Jiann-Ping Hsu College of Public Health, and Intermediate States
Georgia Southern University, Statesboro, Georgia Qualitative and Quantitative Assessments Ronald B. Geskus
Qi Jiang and Weili He
Bruce W. Turnbull, Professor, School of Operations Research and Industrial Engineering, Data and Safety Monitoring Committees
Cornell University, Ithaca, New York Bioequivalence and Statistics in Clinical
in Clinical Trials, Second Edition
Pharmacology, Second Edition
Published Titles Jay Herson
Scott Patterson and Byron Jones
Design and Analysis of Animal Studies
Adaptive Design Methods in Clinical Basic Statistics and Pharmaceutical Biosimilar Clinical Development:
in Pharmaceutical Development
Trials, Second Edition Statistical Applications, Second Edition Scientific Considerations and New
Shein-Chung Chow and Jen-pei Liu
Shein-Chung Chow and Mark Chang James E. De Muth Methodologies
Design and Analysis of Bioavailability
Adaptive Designs for Sequential Bayesian Adaptive Methods for Kerry B. Barker, Sandeep M. Menon,
and Bioequivalence Studies, Third Edition
Treatment Allocation Clinical Trials Ralph B. D’Agostino, Sr., Siyan Xu, and Bo Jin
Shein-Chung Chow and Jen-pei Liu
Alessandro Baldi Antognini Scott M. Berry, Bradley P. Carlin, Biosimilars: Design and Analysis of
Design and Analysis of Bridging Studies
and Alessandra Giovagnoli J. Jack Lee, and Peter Muller Follow-on Biologics
Jen-pei Liu, Shein-Chung Chow,
Adaptive Design Theory and Bayesian Analysis Made Simple: Shein-Chung Chow
and Chin-Fu Hsiao
Implementation Using SAS and R, An Excel GUI for WinBUGS Biostatistics: A Computing Approach
Design & Analysis of Clinical Trials for
Second Edition Phil Woodward Stewart J. Anderson
Economic Evaluation & Reimbursement:
Mark Chang
Bayesian Designs for Phase I–II Cancer Clinical Trials: Current and
An Applied Approach Using SAS & STATA
Advanced Bayesian Methods for Clinical Trials Controversial Issues in Design and
Iftekhar Khan
Medical Test Accuracy Ying Yuan, Hoang Q. Nguyen, Analysis
Design and Analysis of Clinical Trials
Lyle D. Broemeling and Peter F. Thall Stephen L. George, Xiaofei Wang,
for Predictive Medicine
Analyzing Longitudinal Clinical Trial Data: Bayesian Methods for Measures and Herbert Pang
Shigeyuki Matsui, Marc Buyse,
A Practical Guide of Agreement Causal Analysis in Biomedicine and and Richard Simon
Craig Mallinckrodt and Ilya Lipkovich Lyle D. Broemeling Epidemiology: Based on Minimal
Design and Analysis of Clinical Trials with
Applied Biclustering Methods for Big Bayesian Methods for Repeated Measures Sufficient Causation
Time-to-Event Endpoints
and High-Dimensional Data Using R Lyle D. Broemeling Mikel Aickin
Karl E. Peace
Adetayo Kasim, Ziv Shkedy, Bayesian Methods in Epidemiology Clinical and Statistical Considerations in
Design and Analysis of Non-Inferiority Trials
Sebastian Kaiser, Sepp Hochreiter, Lyle D. Broemeling Personalized Medicine
Mark D. Rothmann, Brian L. Wiens,
and Willem Talloen Claudio Carini, Sandeep Menon, and Mark Chang
Bayesian Methods in Health Economics and Ivan S. F. Chan
Applied Meta-Analysis with R Gianluca Baio Clinical Trial Data Analysis using R
Difference Equations with Public Health
Ding-Geng (Din) Chen and Karl E. Peace Ding-Geng (Din) Chen and Karl E. Peace
Bayesian Missing Data Problems: EM, Applications
Applied Surrogate Endpoint Evaluation Data Augmentation and Noniterative Clinical Trial Methodology Lemuel A. Moyé and Asha Seth Kapadia
Methods with SAS and R Computation Karl E. Peace and Ding-Geng (Din) Chen
DNA Methylation Microarrays:
Ariel Alonso, Theophile Bigirumurame,
Ming T. Tan, Guo-Liang Tian, Computational Methods in Biomedical
Experimental Design and Statistical
Tomasz Burzykowski, Marc Buyse,
and Kai Wang Ng Research
Analysis
Geert Molenberghs, Leacky Muchene,
Ravindra Khattree and Dayanand N. Naik
Sun-Chong Wang and Arturas Petronis
Nolen Joy Perualila, Ziv Shkedy,
and Wim Van der Elst
Published Titles
Bayesian Modeling in Bioinformatics Computational Pharmacokinetics
Dipak K. Dey, Samiran Ghosh, Anders Källén
and Bani K. Mallick
Confidence Intervals for Proportions
Benefit-Risk Assessment in and Related Measures of Effect Size
Pharmaceutical Research and Robert G. Newcombe
Development
Controversial Statistical Issues in
Andreas Sashegyi, James Felli,
Clinical Trials
and Rebecca Noel
Shein-Chung Chow
Benefit-Risk Assessment Methods in
Data Analysis with Competing Risks
Medical Product Development: Bridging
and Intermediate States
Qualitative and Quantitative Assessments
Ronald B. Geskus
Qi Jiang and Weili He
Data and Safety Monitoring Committees
Bioequivalence and Statistics in Clinical
in Clinical Trials, Second Edition
Pharmacology, Second Edition
Jay Herson
Scott Patterson and Byron Jones
Design and Analysis of Animal Studies
Biosimilar Clinical Development:
in Pharmaceutical Development
Scientific Considerations and New
Shein-Chung Chow and Jen-pei Liu
Methodologies
Design and Analysis of Bioavailability
Kerry B. Barker, Sandeep M. Menon,
and Bioequivalence Studies, Third Edition
Ralph B. D’Agostino, Sr., Siyan Xu, and Bo Jin
Shein-Chung Chow and Jen-pei Liu
Biosimilars: Design and Analysis of
Design and Analysis of Bridging Studies
Follow-on Biologics
Jen-pei Liu, Shein-Chung Chow,
Shein-Chung Chow
and Chin-Fu Hsiao
Biostatistics: A Computing Approach
Design & Analysis of Clinical Trials for
Stewart J. Anderson
Economic Evaluation & Reimbursement:
Cancer Clinical Trials: Current and
An Applied Approach Using SAS & STATA
Controversial Issues in Design and
Iftekhar Khan
Analysis
Design and Analysis of Clinical Trials
Stephen L. George, Xiaofei Wang,
for Predictive Medicine
and Herbert Pang
Shigeyuki Matsui, Marc Buyse,
Causal Analysis in Biomedicine and and Richard Simon
Epidemiology: Based on Minimal
Design and Analysis of Clinical Trials with
Sufficient Causation
Time-to-Event Endpoints
Mikel Aickin
Karl E. Peace
Clinical and Statistical Considerations in
Design and Analysis of Non-Inferiority Trials
Personalized Medicine
Mark D. Rothmann, Brian L. Wiens,
Claudio Carini, Sandeep Menon, and Mark Chang
and Ivan S. F. Chan
Clinical Trial Data Analysis using R
Difference Equations with Public Health
Ding-Geng (Din) Chen and Karl E. Peace
Applications
Clinical Trial Methodology
Lemuel A. Moyé and Asha Seth Kapadia
Karl E. Peace and Ding-Geng (Din) Chen
DNA Methylation Microarrays:
Computational Methods in Biomedical
Experimental Design and Statistical
Research
Analysis
Ravindra Khattree and Dayanand N. Naik
Sun-Chong Wang and Arturas Petronis
Published Titles Published Titles
DNA Microarrays and Related Genomics Introductory Adaptive Trial Designs:
Patient-Reported Outcomes: Statistical Evaluation of Diagnostic
Techniques: Design, Analysis, and A Practical Guide with R
Measurement, Implementation and Performance: Topics in ROC Analysis
Interpretation of Experiments Mark Chang
Interpretation Kelly H. Zou, Aiyi Liu, Andriy Bandos,
David B. Allison, Grier P. Page,
Joint Models for Longitudinal and Time- Joseph C. Cappelleri, Kelly H. Zou, Lucila Ohno-Machado, and Howard Rockette
T. Mark Beasley, and Jode W. Edwards
to-Event Data: With Applications in R Andrew G. Bushmakin, Jose Ma. J. Alvir,
Statistical Methods for Clinical Trials
Dose Finding by the Continual Dimitris Rizopoulos Demissie Alemayehu, and Tara Symonds
Mark X. Norleans
Reassessment Method
Measures of Interobserver Agreement Quantitative Evaluation of Safety in Drug
Statistical Methods for Drug Safety
Ying Kuen Cheung
and Reliability, Second Edition Development: Design, Analysis and
Robert D. Gibbons and Anup K. Amatya
Dynamical Biostatistical Models Mohamed M. Shoukri Reporting
Statistical Methods for Healthcare
Daniel Commenges and Qi Jiang and H. Amy Xia
Medical Biostatistics, Third Edition
Performance Monitoring
Hélène Jacqmin-Gadda
A. Indrayan Quantitative Methods for Traditional
Alex Bottle and Paul Aylin
Elementary Bayesian Biostatistics Chinese Medicine Development
Meta-Analysis in Medicine and
Statistical Methods for Immunogenicity
Lemuel A. Moyé Shein-Chung Chow
Health Policy
Assessment
Emerging Non-Clinical Biostatistics in Dalene Stangl and Donald A. Berry Randomized Clinical Trials of
Harry Yang, Jianchun Zhang, Binbing Yu,
Biopharmaceutical Development and Nonpharmacological Treatments
Mixed Effects Models for the Population and Wei Zhao
Manufacturing Isabelle Boutron, Philippe Ravaud,
Approach: Models, Tasks, Methods
Statistical Methods in Drug Combination
Harry Yang and David Moher
and Tools
Studies
Empirical Likelihood Method in Marc Lavielle Randomized Phase II Cancer
Wei Zhao and Harry Yang
Survival Analysis Clinical Trials
Modeling to Inform Infectious Disease
Statistical Testing Strategies in the
Mai Zhou Sin-Ho Jung
Control
Health Sciences
Essentials of a Successful Biostatistical Niels G. Becker Sample Size Calculations for Clustered
Albert Vexler, Alan D. Hutson,
Collaboration and Longitudinal Outcomes in Clinical
Modern Adaptive Randomized Clinical and Xiwei Chen
Arul Earnest Research
Trials: Statistical and Practical Aspects
Statistics in Drug Research:
Chul Ahn, Moonseong Heo,
Exposure–Response Modeling: Methods Oleksandr Sverdlov
Methodologies and Recent
and Song Zhang
and Practical Implementation
Monte Carlo Simulation for the Developments
Jixian Wang Sample Size Calculations in Clinical
Pharmaceutical Industry: Concepts, Shein-Chung Chow and Jun Shao
Research, Second Edition
Frailty Models in Survival Analysis Algorithms, and Case Studies
Statistics in the Pharmaceutical Industry,
Shein-Chung Chow, Jun Shao,
Andreas Wienke Mark Chang
Third Edition
and Hansheng Wang
Fundamental Concepts for New Clinical Multiregional Clinical Trials for Ralph Buncher and Jia-Yeong Tsay
Statistical Analysis of Human Growth
Trialists Simultaneous Global New Drug Survival Analysis in Medicine and
and Development
Scott Evans and Naitee Ting Development Yin Bun Cheung Genetics
Generalized Linear Models: A Bayesian Joshua Chen and Hui Quan Jialiang Li and Shuangge Ma
Statistical Design and Analysis of Clinical
Perspective Multiple Testing Problems in Theory of Drug Development
Trials: Principles and Methods
Dipak K. Dey, Sujit K. Ghosh, and Pharmaceutical Statistics Eric B. Holmgren
Weichung Joe Shih and Joseph Aisner
Bani K. Mallick Alex Dmitrienko, Ajit C. Tamhane,
Translational Medicine: Strategies and
Handbook of Regression and Modeling: and Frank Bretz Statistical Design and Analysis of
Statistical Methods
Stability Studies
Applications for the Clinical and Noninferiority Testing in Clinical Trials: Dennis Cosmatos and Shein-Chung Chow
Shein-Chung Chow
Pharmaceutical Industries Issues and Challenges
Daryl S. Paulson Tie-Hua Ng
Inference Principles for Biostatisticians Optimal Design for Nonlinear Response
Ian C. Marschner Models
Interval-Censored Time-to-Event Data: Valerii V. Fedorov and Sergei L. Leonov
Methods and Applications
Ding-Geng (Din) Chen, Jianguo Sun,
and Karl E. Peace
Published Titles
Patient-Reported Outcomes: Statistical Evaluation of Diagnostic
Measurement, Implementation and Performance: Topics in ROC Analysis
Interpretation Kelly H. Zou, Aiyi Liu, Andriy Bandos,
Joseph C. Cappelleri, Kelly H. Zou, Lucila Ohno-Machado, and Howard Rockette
Andrew G. Bushmakin, Jose Ma. J. Alvir,
Statistical Methods for Clinical Trials
Demissie Alemayehu, and Tara Symonds
Mark X. Norleans
Quantitative Evaluation of Safety in Drug
Statistical Methods for Drug Safety
Development: Design, Analysis and
Robert D. Gibbons and Anup K. Amatya
Reporting
Statistical Methods for Healthcare
Qi Jiang and H. Amy Xia
Performance Monitoring
Quantitative Methods for Traditional
Alex Bottle and Paul Aylin
Chinese Medicine Development
Statistical Methods for Immunogenicity
Shein-Chung Chow
Assessment
Randomized Clinical Trials of
Harry Yang, Jianchun Zhang, Binbing Yu,
Nonpharmacological Treatments
and Wei Zhao
Isabelle Boutron, Philippe Ravaud,
Statistical Methods in Drug Combination
and David Moher
Studies
Randomized Phase II Cancer
Wei Zhao and Harry Yang
Clinical Trials
Statistical Testing Strategies in the
Sin-Ho Jung
Health Sciences
Sample Size Calculations for Clustered
Albert Vexler, Alan D. Hutson,
and Longitudinal Outcomes in Clinical
and Xiwei Chen
Research
Statistics in Drug Research:
Chul Ahn, Moonseong Heo,
Methodologies and Recent
and Song Zhang
Developments
Sample Size Calculations in Clinical
Shein-Chung Chow and Jun Shao
Research, Second Edition
Statistics in the Pharmaceutical Industry,
Shein-Chung Chow, Jun Shao,
Third Edition
and Hansheng Wang
Ralph Buncher and Jia-Yeong Tsay
Statistical Analysis of Human Growth
Survival Analysis in Medicine and
and Development
Yin Bun Cheung Genetics
Jialiang Li and Shuangge Ma
Statistical Design and Analysis of Clinical
Theory of Drug Development
Trials: Principles and Methods
Eric B. Holmgren
Weichung Joe Shih and Joseph Aisner
Translational Medicine: Strategies and
Statistical Design and Analysis of
Statistical Methods
Stability Studies
Dennis Cosmatos and Shein-Chung Chow
Shein-Chung Chow
Data and
Safety Monitoring
Committees
in Clinical Trials
Second Edition
Jay Herson
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, USA
Data and
Safety Monitoring
Committees
in Clinical Trials
Second Edition
Jay Herson
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, USA
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Library of Congress Cataloging‑in‑Publication Data

Names: Herson, Jay, author.
Title: Data and safety monitoring committees in clinical trials / Jay Herson,
Ph.D.
Description: Second edition. | Boca Raton : Taylor & Francis, 2017. | Series:
Chapman & Hall/CRC biostatistics series | Includes bibliographical
references and index.
Identifiers: LCCN 2016026387 | ISBN 9781498784108 (hardback)
Subjects: LCSH: Drugs--Testing--Evaluation. | Drugs--Testing--Statistical
methods--Evaluation.
Classification: LCC RM301.27 .H47 2017 | DDC 615.1/9--dc23
LC record available at https://lccn.loc.gov/2016026387
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To the patients who volunteer for clinical trials—past, present, and future.