Sample Size Determination In Clinical Trials With Multiple Endpoints
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Sample Size Determination in Clinical Trials with Multiple Endpoints
Author | : Takashi Sozu,Tomoyuki Sugimoto,Toshimitsu Hamasaki,Scott R. Evans |
Publsiher | : Springer |
Total Pages | : 95 |
Release | : 2015-08-20 |
Genre | : Mathematics |
ISBN | : 9783319220055 |
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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.
Sample Size Determination in Clinical Trials with Multiple Objectives
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Author | : Takashi Sozu,Tomoyuki Sugimoto,Toshimitsu Hamasaki,Scott R. Evans |
Publsiher | : Springer |
Total Pages | : 250 |
Release | : 2015-12-06 |
Genre | : Mathematics |
ISBN | : 3319211633 |
Download Sample Size Determination in Clinical Trials with Multiple Objectives Book in PDF, Epub and Kindle
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 Tables for Clinical Studies
Author | : David Machin,Michael J. Campbell,Say Beng Tan,Sze Huey Tan |
Publsiher | : John Wiley & Sons |
Total Pages | : 319 |
Release | : 2011-08-26 |
Genre | : Medical |
ISBN | : 9781444357967 |
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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.
Sample Size Calculations in Clinical Research
Author | : Shein-Chung Chow,Jun Shao,Hansheng Wang,Yuliya Lokhnygina |
Publsiher | : CRC Press |
Total Pages | : 954 |
Release | : 2017-08-15 |
Genre | : Mathematics |
ISBN | : 9781351727112 |
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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.
Sample Size Calculations in Clinical Research
Author | : Shein-Chung Chow,Jun Shao,Hansheng Wang,Yuliya Lokhnygina |
Publsiher | : CRC Press |
Total Pages | : 510 |
Release | : 2017-08-15 |
Genre | : Mathematics |
ISBN | : 9781351727129 |
Download Sample Size Calculations in Clinical Research Book in PDF, Epub and Kindle
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 |
Publsiher | : CRC Press |
Total Pages | : 330 |
Release | : 2009-08-26 |
Genre | : Mathematics |
ISBN | : 9781584887409 |
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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
Sample Size Calculations in Clinical Research Second Edition
Author | : Shein-Chung Chow,Hansheng Wang,Jun Shao |
Publsiher | : CRC Press |
Total Pages | : 481 |
Release | : 2007-08-22 |
Genre | : Mathematics |
ISBN | : 9781439870938 |
Download Sample Size Calculations in Clinical Research Second Edition Book in PDF, Epub and Kindle
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.
Planning and Analyzing Clinical Trials with Composite Endpoints
Author | : Geraldine Rauch,Svenja Schüler,Meinhard Kieser |
Publsiher | : Springer |
Total Pages | : 255 |
Release | : 2018-05-22 |
Genre | : Medical |
ISBN | : 9783319737706 |
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This book addresses the most important aspects of how to plan and evaluate clinical trials with a composite primary endpoint to guarantee a clinically meaningful and valid interpretation of the results. Composite endpoints are often used as primary efficacy variables for clinical trials, particularly in the fields of oncology and cardiology. These endpoints combine several variables of interest within a single composite measure, and as a result, all variables that are of major clinical relevance can be considered in the primary analysis without the need to adjust for multiplicity. Moreover, composite endpoints are intended to increase the size of the expected effects thus making clinical trials more powerful. The book offers practical advice for statisticians and medical experts involved in the planning and analysis of clinical trials. For readers who are mainly interested in the application of the methods, all the approaches are illustrated with real-world clinical trial examples, and the software codes required for fast and easy implementation are provided. The book also discusses all the methods in the context of relevant guidelines related to the topic. To benefit most from the book, readers should be familiar with the principles of clinical trials and basic statistical methods.