Methods And Applications Of Sample Size Calculation And Recalculation In Clinical Trials

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Methods and Applications of Sample Size Calculation and Recalculation in Clinical Trials

Author : Meinhard Kieser
Publisher : Springer Nature
ISBN 13 : 3030495280
Total Pages : 391 pages
Book Rating : 4.0/5 (34 download)

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Book Synopsis Methods and Applications of Sample Size Calculation and Recalculation in Clinical Trials by : Meinhard Kieser

Download or read book Methods and Applications of Sample Size Calculation and Recalculation in Clinical Trials written by Meinhard Kieser and published by Springer Nature. This book was released on 2020-11-19 with total page 391 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an extensive overview of the principles and methods of sample size calculation and recalculation in clinical trials. Appropriate calculation of the required sample size is crucial for the success of clinical trials. At the same time, a sample size that is too small or too large is problematic due to ethical, scientific, and economic reasons. Therefore, state-of-the art methods are required when planning clinical trials. Part I describes a general framework for deriving sample size calculation procedures. This enables an understanding of the common principles underlying the numerous methods presented in the following chapters. Part II addresses the fixed sample size design, where the required sample size is determined in the planning stage and is not changed afterwards. It covers sample size calculation methods for superiority, non-inferiority, and equivalence trials, as well as comparisons between two and more than two groups. A wide range of further topics is discussed, including sample size calculation for multiple comparisons, safety assessment, and multi-regional trials. There is often some uncertainty about the assumptions to be made when calculating the sample size upfront. Part III presents methods that allow to modify the initially specified sample size based on new information that becomes available during the ongoing trial. Blinded sample size recalculation procedures for internal pilot study designs are considered, as well as methods for sample size reassessment in adaptive designs that use unblinded data from interim analyses. The application is illustrated using numerous clinical trial examples, and software code implementing the methods is provided. The book offers theoretical background and practical advice for biostatisticians and clinicians from the pharmaceutical industry and academia who are involved in clinical trials. Covering basic as well as more advanced and recently developed methods, it is suitable for beginners, experienced applied statisticians, and practitioners. To gain maximum benefit, readers should be familiar with introductory statistics. The content of this book has been successfully used for courses on the topic.

Sample Size Calculations in Clinical Research, Second Edition

Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 1439870934
Total Pages : 481 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Sample Size Calculations in Clinical Research, Second Edition by : Shein-Chung Chow

Download or read book Sample Size Calculations in Clinical Research, Second Edition written by Shein-Chung Chow and published by CRC Press. This book was released on 2007-08-22 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: Focusing on an integral part of pharmaceutical development, Sample Size Calculations in Clinical Research, Second Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. It provides sample size formulas and procedures for testing equality, noninferiority/superiority, and equivalence. A comprehensive and unified presentation of statistical concepts and practical applications, this book highlights the interactions between clinicians and biostatisticians, includes a well-balanced summary of current and emerging clinical issues, and explores recently developed statistical methodologies for sample size calculation. Whenever possible, each chapter provides a brief history or background, regulatory requirements, statistical designs and methods for data analysis, real-world examples, future research developments, and related references. One of the few books to systematically summarize clinical research procedures, this edition contains new chapters that focus on three key areas of this field. Incorporating the material of this book in your work will help ensure the validity and, ultimately, the success of your clinical studies.

Sample Size Calculations in Clinical Research

Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 1351727117
Total Pages : 954 pages
Book Rating : 4.3/5 (517 download)

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Book Synopsis Sample Size Calculations in Clinical Research by : Shein-Chung Chow

Download or read book Sample Size Calculations in Clinical Research written by Shein-Chung Chow and published by CRC Press. This book was released on 2017-08-15 with total page 954 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the Second Edition: "... this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics "This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered ..." – Journal of the Royal Statistical Society Sample Size Calculations in Clinical Research, Third Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. A comprehensive and unified presentation of statistical concepts and practical applications, this book includes a well-balanced summary of current and emerging clinical issues, regulatory requirements, and recently developed statistical methodologies for sample size calculation. Features: Compares the relative merits and disadvantages of statistical methods for sample size calculations Explains how the formulae and procedures for sample size calculations can be used in a variety of clinical research and development stages Presents real-world examples from several therapeutic areas, including cardiovascular medicine, the central nervous system, anti-infective medicine, oncology, and women’s health Provides sample size calculations for dose response studies, microarray studies, and Bayesian approaches This new edition is updated throughout, includes many new sections, and five new chapters on emerging topics: two stage seamless adaptive designs, cluster randomized trial design, zero-inflated Poisson distribution, clinical trials with extremely low incidence rates, and clinical trial simulation.

Sample Size Calculations in Clinical Research

Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 1351727125
Total Pages : 510 pages
Book Rating : 4.3/5 (517 download)

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Book Synopsis Sample Size Calculations in Clinical Research by : Shein-Chung Chow

Download or read book Sample Size Calculations in Clinical Research written by Shein-Chung Chow and published by CRC Press. This book was released on 2017-08-15 with total page 510 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the Second Edition: "... this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics "This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered ..." – Journal of the Royal Statistical Society Sample Size Calculations in Clinical Research, Third Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. A comprehensive and unified presentation of statistical concepts and practical applications, this book includes a well-balanced summary of current and emerging clinical issues, regulatory requirements, and recently developed statistical methodologies for sample size calculation. Features: Compares the relative merits and disadvantages of statistical methods for sample size calculations Explains how the formulae and procedures for sample size calculations can be used in a variety of clinical research and development stages Presents real-world examples from several therapeutic areas, including cardiovascular medicine, the central nervous system, anti-infective medicine, oncology, and women’s health Provides sample size calculations for dose response studies, microarray studies, and Bayesian approaches This new edition is updated throughout, includes many new sections, and five new chapters on emerging topics: two stage seamless adaptive designs, cluster randomized trial design, zero-inflated Poisson distribution, clinical trials with extremely low incidence rates, and clinical trial simulation.

Sample Sizes for Clinical Trials

Author : Steven A. Julious
Publisher : CRC Press
ISBN 13 : 9781584887409
Total Pages : 317 pages
Book Rating : 4.8/5 (874 download)

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Book Synopsis Sample Sizes for Clinical Trials by : Steven A. Julious

Download or read book Sample Sizes for Clinical Trials written by Steven A. Julious and published by CRC Press. This book was released on 2009-08-26 with total page 317 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drawing on various real-world applications, Sample Sizes for Clinical Trials takes readers through the process of calculating sample sizes for many types of clinical trials. It provides descriptions of the calculations with a practical emphasis. Focusing on normal, binary, ordinal, and survival data, the book explores a range of trials, including superiority, equivalence, non-inferiority, bioequivalence, and precision for both parallel group and crossover designs. The author discusses how trial objectives impact the study design with respect to the derivation of formulae for sample size calculations. He uses real-life studies throughout to show how the concepts and calculations can be employed. This work underscores the importance of sample size calculation in the design of a clinical trial. With useful calculation tables throughout, it enables readers to quickly find an appropriate formula, formula application, and associated worked example. Watch the author speak about this book at JSM 2012 in San Diego.

Sample Size Determination

Author :
Publisher :
ISBN 13 : 9780817647100
Total Pages : 300 pages
Book Rating : 4.6/5 (471 download)

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Book Synopsis Sample Size Determination by :

Download or read book Sample Size Determination written by and published by . This book was released on 2009 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Sample Size Tables for Clinical Studies

Author : David Machin
Publisher : John Wiley & Sons
ISBN 13 : 1444357964
Total Pages : 319 pages
Book Rating : 4.4/5 (443 download)

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Book Synopsis Sample Size Tables for Clinical Studies by : David Machin

Download or read book Sample Size Tables for Clinical Studies written by David Machin and published by John Wiley & Sons. This book was released on 2011-08-26 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides statisticians and researchers with the statistical tools - equations, formulae and numerical tables - to design and plan clinical studies and carry out accurate, reliable and reproducible analysis of the data so obtained. There is no way around this as incorrect procedure in clinical studies means that the researcher's paper will not be accepted by a peer-reviewed journal. Planning and analysing clinical studies is a very complicated business and this book provides indispensible factual information. Please go to http://booksupport.wiley.com and enter 9781405146500 to easily download the supporting materials.

Sample Size Determination in Clinical Trials with Multiple Endpoints

Author : Takashi Sozu
Publisher : Springer
ISBN 13 : 3319220055
Total Pages : 95 pages
Book Rating : 4.3/5 (192 download)

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Book Synopsis Sample Size Determination in Clinical Trials with Multiple Endpoints by : Takashi Sozu

Download or read book Sample Size Determination in Clinical Trials with Multiple Endpoints written by Takashi Sozu and published by Springer. This book was released on 2015-08-20 with total page 95 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book integrates recent methodological developments for calculating the sample size and power in trials with more than one endpoint considered as multiple primary or co-primary, offering an important reference work for statisticians working in this area. The determination of sample size and the evaluation of power are fundamental and critical elements in the design of clinical trials. If the sample size is too small, important effects may go unnoticed; if the sample size is too large, it represents a waste of resources and unethically puts more participants at risk than necessary. Recently many clinical trials have been designed with more than one endpoint considered as multiple primary or co-primary, creating a need for new approaches to the design and analysis of these clinical trials. The book focuses on the evaluation of power and sample size determination when comparing the effects of two interventions in superiority clinical trials with multiple endpoints. Methods for sample size calculation in clinical trials where the alternative hypothesis is that there are effects on ALL endpoints are discussed in detail. The book also briefly examines trials designed with an alternative hypothesis of an effect on AT LEAST ONE endpoint with a prespecified non-ordering of endpoints.

Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research

Author : Chul Ahn
Publisher : CRC Press
ISBN 13 : 1466556269
Total Pages : 262 pages
Book Rating : 4.4/5 (665 download)

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Book Synopsis Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research by : Chul Ahn

Download or read book Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research written by Chul Ahn and published by CRC Press. This book was released on 2014-12-09 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accurate sample size calculation ensures that clinical studies have adequate power to detect clinically meaningful effects. This results in the efficient use of resources and avoids exposing a disproportionate number of patients to experimental treatments caused by an overpowered study. Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research explains how to determine sample size for studies with correlated outcomes, which are widely implemented in medical, epidemiological, and behavioral studies. The book focuses on issues specific to the two types of correlated outcomes: longitudinal and clustered. For clustered studies, the authors provide sample size formulas that accommodate variable cluster sizes and within-cluster correlation. For longitudinal studies, they present sample size formulas to account for within-subject correlation among repeated measurements and various missing data patterns. For multiple levels of clustering, the level at which to perform randomization actually becomes a design parameter. The authors show how this can greatly impact trial administration, analysis, and sample size requirement. Addressing the overarching theme of sample size determination for correlated outcomes, this book provides a useful resource for biostatisticians, clinical investigators, epidemiologists, and social scientists whose research involves trials with correlated outcomes. Each chapter is self-contained so readers can explore topics relevant to their research projects without having to refer to other chapters.

Sample Size Determination and Power

Author : Thomas P. Ryan
Publisher : John Wiley & Sons
ISBN 13 : 1118439228
Total Pages : 230 pages
Book Rating : 4.1/5 (184 download)

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Book Synopsis Sample Size Determination and Power by : Thomas P. Ryan

Download or read book Sample Size Determination and Power written by Thomas P. Ryan and published by John Wiley & Sons. This book was released on 2013-05-28 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive approach to sample size determination and power with applications for a variety of fields Sample Size Determination and Power features a modern introduction to the applicability of sample size determination and provides a variety of discussions on broad topics including epidemiology, microarrays, survival analysis and reliability, design of experiments, regression, and confidence intervals. The book distinctively merges applications from numerous fields such as statistics, biostatistics, the health sciences, and engineering in order to provide a complete introduction to the general statistical use of sample size determination. Advanced topics including multivariate analysis, clinical trials, and quality improvement are addressed, and in addition, the book provides considerable guidance on available software for sample size determination. Written by a well-known author who has extensively class-tested the material, Sample Size Determination and Power: Highlights the applicability of sample size determination and provides extensive literature coverage Presents a modern, general approach to relevant software to guide sample size determination including CATD (computer-aided trial design) Addresses the use of sample size determination in grant proposals and provides up-to-date references for grant investigators An appealing reference book for scientific researchers in a variety of fields, such as statistics, biostatistics, the health sciences, mathematics, ecology, and geology, who use sampling and estimation methods in their work, Sample Size Determination and Power is also an ideal supplementary text for upper-level undergraduate and graduate-level courses in statistical sampling.

Sample Sizes for Clinical, Laboratory and Epidemiology Studies

Author : David Machin
Publisher : John Wiley & Sons
ISBN 13 : 1118874943
Total Pages : 412 pages
Book Rating : 4.1/5 (188 download)

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Book Synopsis Sample Sizes for Clinical, Laboratory and Epidemiology Studies by : David Machin

Download or read book Sample Sizes for Clinical, Laboratory and Epidemiology Studies written by David Machin and published by John Wiley & Sons. This book was released on 2018-08-20 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt: An authoritative resource that offers the statistical tools and software needed to design and plan valid clinical studies Now in its fourth and extended edition, Sample Sizes for Clinical, Laboratory and Epidemiology Studiesincludes the sample size software (SSS) and formulae and numerical tables needed to design valid clinical studies. The text covers clinical as well as laboratory and epidemiology studies and contains the information needed to ensure a study will form a valid contribution to medical research. The authors, noted experts in the field, explain step by step and explore the wide range of considerations necessary to assist investigational teams when deriving an appropriate sample size for their when planned study. The book contains sets of sample size tables with companion explanations and clear worked out examples based on real data. In addition, the text offers bibliography and references sections that are designed to be helpful with guidance on the principles discussed. This revised fourth edition: Offers the only text available to include sample size software for use in designing and planning clinical studies Presents new and extended chapters with many additional and refreshed examples Includes clear explanations of the principles and methodologies involved with relevant practical examples Makes clear a complex but vital topic that is designed to ensure valid methodology and publishable results Contains guidance from an internationally recognised team of medical statistics experts Written for medical researchers from all specialities and medical statisticians, Sample Sizes for Clinical, Laboratory and EpidemiologyStudies offers an updated fourth edition of the important guide for designing and planning reliable and evidence based clinical studies.

Sample Size Methodology

Author : M. M. Desu
Publisher : Elsevier
ISBN 13 : 0323139566
Total Pages : 135 pages
Book Rating : 4.3/5 (231 download)

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Book Synopsis Sample Size Methodology by : M. M. Desu

Download or read book Sample Size Methodology written by M. M. Desu and published by Elsevier. This book was released on 2012-12-02 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: One of the most important problems in designing an experiment or a survey is sample size determination and this book presents the currently available methodology. It includes both random sampling from standard probability distributions and from finite populations. Also discussed is sample size determination for estimating parameters in a Bayesian setting by considering the posterior distribution of the parameter and specifying the necessary requirements. The determination of the sample size is considered for ranking and selection problems as well as for the design of clinical trials. Appropriate techniques for attacking the general question of sample size determination in problems of estimation, tests of hypotheses, selection, and clinical trial design are all presented, and will help the reader in formulating an appropriate problem of sample size and in obtaining the solution. The book can be used as a text in a senior-level or a graduate course on sample size methodology. Annotated list of tables in appendixSupplemental problems at the end of book

Case Studies in Innovative Clinical Trials

Author : Kristine Broglio
Publisher : CRC Press
ISBN 13 : 1000987213
Total Pages : 303 pages
Book Rating : 4.0/5 (9 download)

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Book Synopsis Case Studies in Innovative Clinical Trials by : Kristine Broglio

Download or read book Case Studies in Innovative Clinical Trials written by Kristine Broglio and published by CRC Press. This book was released on 2023-11-27 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug development is a strictly regulated area. As such, marketing approval of a new drug depends heavily, if not exclusively, on evidence generated from clinical trials. Drug development has seen tremendous innovation in science and technology that has revolutionized the treatment of some diseases. And yet, the statistical design and practical conduct of the clinical trials used to test new therapeutics for safety and efficacy have changed very little over the decades. Our approach to clinical trials is steeped in convention and tradition. The large, fixed, randomized controlled trial methods that have been the gold standard are well understood and expected by many trial stakeholders. However, this approach is not well suited to all aspects of modern drug development and the current competitive landscape. We now see new therapies that target a small fraction of the patient population, rare diseases with high unmet medical needs, and pediatric populations that must wait for years for new drug approvals from the time that therapies are approved in adults. Large randomized clinical trials are at best inefficient and at worst completely infeasible in many modern clinical settings. Advances in technology and data infrastructure call for innovations in clinical trial design. Despite advances in statistical methods, the availability of information, and computing power, the actual experience with innovative design in clinical trials across industry and academia is limited. This book will be an important showcase of the potential for these innovative designs in modern drug development and will be an important resource to guide those who wish to undertake them for themselves. This book is ideal for professionals in the pharmaceutical industry and regulatory agencies, but it will also be useful to academic researchers, faculty members, and graduate students in statistics, biostatistics, public health, and epidemiology due to its focus on innovation. Key Features: Is written by pharmaceutical industry experts, academic researchers, and regulatory reviewers; this is the first book providing a comprehensive set of case studies related to statistical methodology, implementation, regulatory considerations, and communication of complex innovative trial design Has a broad appeal to a multitude of readers across academia, industry, and regulatory agencies Each contribution is a practical case study that can speak to the benefits of an innovative approach but also balance that with the real-life challenges encountered A complete understanding of what is actually being done in modern clinical trials will broaden the reader’s capabilities and provide examples to first mimic and then customize and expand upon when exploring these ideas on their own

Sample Size Determination in Clinical Trials with Multiple Objectives

Author : Takashi Sozu
Publisher : Springer
ISBN 13 : 9783319211633
Total Pages : 250 pages
Book Rating : 4.2/5 (116 download)

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Book Synopsis Sample Size Determination in Clinical Trials with Multiple Objectives by : Takashi Sozu

Download or read book Sample Size Determination in Clinical Trials with Multiple Objectives written by Takashi Sozu and published by Springer. This book was released on 2015-12-06 with total page 250 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book integrates recent methodological developments for calculating the sample size and power in trials with more than one endpoint considered as multiple primary or co-primary, offering an important reference work for statisticians working in this area. The determination of sample size and the evaluation of power are fundamental and critical elements in the design of clinical trials. If the sample size is too small, important effects may go unnoticed; if the sample size is too large, it represents a waste of resources and unethically puts more participants at risk than necessary. Recently many clinical trials have been designed with more than one endpoint considered as multiple primary or co-primary, creating a need for new approaches to the design and analysis of these clinical trials. The book focuses on the evaluation of power and sample size determination when comparing the effects of two interventions in superiority clinical trials with multiple endpoints. Methods for sample size calculation in clinical trials where the alternative hypothesis is that there are effects on ALL endpoints are discussed in detail. The book also briefly examines trials designed with an alternative hypothesis of an effect on AT LEAST ONE endpoint with a prespecified non-ordering of endpoints.

Clinical Trial Data Analysis Using R

Author : Ding-Geng (Din) Chen
Publisher : CRC Press
ISBN 13 : 1439840210
Total Pages : 384 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Clinical Trial Data Analysis Using R by : Ding-Geng (Din) Chen

Download or read book Clinical Trial Data Analysis Using R written by Ding-Geng (Din) Chen and published by CRC Press. This book was released on 2010-12-14 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: Too often in biostatistical research and clinical trials, a knowledge gap exists between developed statistical methods and the applications of these methods. Filling this gap, Clinical Trial Data Analysis Using R provides a thorough presentation of biostatistical analyses of clinical trial data and shows step by step how to implement the statistical methods using R. The book’s practical, detailed approach draws on the authors’ 30 years of real-world experience in biostatistical research and clinical development. 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 develop analysis code step by step 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. With step-by-step illustrations of R implementations, this book shows how to easily use R to simulate and analyze data from a clinical trial. It describes numerous up-to-date statistical methods and offers sound guidance on the processes involved in clinical trials.

Introduction to Statistical Methods for Clinical Trials

Author : Thomas D. Cook
Publisher : CRC Press
ISBN 13 : 1584880279
Total Pages : 465 pages
Book Rating : 4.5/5 (848 download)

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Book Synopsis Introduction to Statistical Methods for Clinical Trials by : Thomas D. Cook

Download or read book Introduction to Statistical Methods for Clinical Trials written by Thomas D. Cook and published by CRC Press. This book was released on 2007-11-19 with total page 465 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials have become essential research tools for evaluating the benefits and risks of new interventions for the treatment and prevention of diseases, from cardiovascular disease to cancer to AIDS. Based on the authors’ collective experiences in this field, Introduction to Statistical Methods for Clinical Trials presents various statistical topics relevant to the design, monitoring, and analysis of a clinical trial. After reviewing the history, ethics, protocol, and regulatory issues of clinical trials, the book provides guidelines for formulating primary and secondary questions and translating clinical questions into statistical ones. It examines designs used in clinical trials, presents methods for determining sample size, and introduces constrained randomization procedures. The authors also discuss how various types of data must be collected to answer key questions in a trial. In addition, they explore common analysis methods, describe statistical methods that determine what an emerging trend represents, and present issues that arise in the analysis of data. The book concludes with suggestions for reporting trial results that are consistent with universal guidelines recommended by medical journals. Developed from a course taught at the University of Wisconsin for the past 25 years, this textbook provides a solid understanding of the statistical approaches used in the design, conduct, and analysis of clinical trials.

Statistical Design, Monitoring, and Analysis of Clinical Trials

Author : Weichung Joe Shih
Publisher : CRC Press
ISBN 13 : 1000462757
Total Pages : 405 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Statistical Design, Monitoring, and Analysis of Clinical Trials by : Weichung Joe Shih

Download or read book Statistical Design, Monitoring, and Analysis of Clinical Trials written by Weichung Joe Shih and published by CRC Press. This book was released on 2021-10-25 with total page 405 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition concentrates on the biostatistics component of clinical trials. This new edition is updated throughout and includes five new chapters. Developed from the authors’ courses taught to public health and medical students, residents, and fellows during the past 20 years, the text shows how biostatistics in clinical trials is an integration of many fundamental scientific principles and statistical methods. The book begins with ethical and safety principles, core trial design concepts, the principles and methods of sample size and power calculation, and analysis of covariance and stratified analysis. It then focuses on sequential designs and methods for two-stage Phase II cancer trials to Phase III group sequential trials, covering monitoring safety, futility, and efficacy. The authors also discuss the development of sample size reestimation and adaptive group sequential procedures, phase 2/3 seamless design and trials with predictive biomarkers, exploit multiple testing procedures, and explain the concept of estimand, intercurrent events, and different missing data processes, and describe how to analyze incomplete data by proper multiple imputations. This text reflects the academic research, commercial development, and public health aspects of clinical trials. It gives students and practitioners a multidisciplinary understanding of the concepts and techniques involved in designing, monitoring, and analyzing various types of trials. The book’s balanced set of homework assignments and in-class exercises are appropriate for students and researchers in (bio)statistics, epidemiology, medicine, pharmacy, and public health.