Sample Size Calculations in Clinical Research

Sample Size Calculations in Clinical Research

Author: Shein-Chung Chow

Publisher: CRC Press

Published: 2017-08-15

Total Pages: 954

ISBN-13: 1351727117

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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.


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

Sample Size Calculations in Clinical Research

Author: Shein-Chung Chow

Publisher: CRC Press

Published: 2003-03-04

Total Pages: 376

ISBN-13: 9780203911341

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Sample size calculation plays an important role in clinical research. It is not uncommon, however, to observe discrepancies among study objectives (or hypotheses), study design, statistical analysis (or test statistic), and sample size calculation. Focusing on sample size calculation for studies conducted during the various phases of clinical resea


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 2003-03-04 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sample size calculation plays an important role in clinical research. It is not uncommon, however, to observe discrepancies among study objectives (or hypotheses), study design, statistical analysis (or test statistic), and sample size calculation. Focusing on sample size calculation for studies conducted during the various phases of clinical resea

Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research

Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research

Author: Chul Ahn

Publisher: CRC Press

Published: 2014-12-09

Total Pages: 262

ISBN-13: 1466556269

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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.


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 Calculations in Clinical Research, Second Edition

Sample Size Calculations in Clinical Research, Second Edition

Author: Shein-Chung Chow

Publisher: CRC Press

Published: 2007-08-22

Total Pages: 481

ISBN-13: 1439870934

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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.


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 Sizes for Clinical Trials

Sample Sizes for Clinical Trials

Author: Steven A. Julious

Publisher: CRC Press

Published: 2009-08-26

Total Pages: 330

ISBN-13: 1584887400

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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 su


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 330 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 su

Sample Size Calculations in Clinical Research

Sample Size Calculations in Clinical Research

Author: Shein-Chung Chow

Publisher: CRC Press

Published: 2017-08-15

Total Pages: 510

ISBN-13: 1351727125

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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.


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 Size Tables for Clinical Studies

Sample Size Tables for Clinical Studies

Author: David Machin

Publisher: John Wiley & Sons

Published: 2011-08-26

Total Pages: 319

ISBN-13: 1444357964

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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.


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 Calculations in Clinical Research

Sample Size Calculations in Clinical Research

Author: Shein-Chung Chow

Publisher: Chapman & Hall/CRC

Published: 2017

Total Pages: 0

ISBN-13: 9781138740983

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Like the well-regarded and bestselling second edition, Sample Size Calculations in Clinical Research, Third Edition, presents statistical procedures for performing sample size calculations during various phases of clinical research and development. This new edition contains updates and four new chapters written specifically for this version.


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 Chapman & Hall/CRC. This book was released on 2017 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Like the well-regarded and bestselling second edition, Sample Size Calculations in Clinical Research, Third Edition, presents statistical procedures for performing sample size calculations during various phases of clinical research and development. This new edition contains updates and four new chapters written specifically for this version.

Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide

Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide

Author: Agency for Health Care Research and Quality (U.S.)

Publisher: Government Printing Office

Published: 2013-02-21

Total Pages: 204

ISBN-13: 1587634236

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This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)


Book Synopsis Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide by : Agency for Health Care Research and Quality (U.S.)

Download or read book Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide written by Agency for Health Care Research and Quality (U.S.) and published by Government Printing Office. This book was released on 2013-02-21 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)

Sample Size Determination in Clinical Trials with Multiple Endpoints

Sample Size Determination in Clinical Trials with Multiple Endpoints

Author: Takashi Sozu

Publisher: Springer

Published: 2015-08-20

Total Pages: 95

ISBN-13: 3319220055

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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.


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.