Sample Size Calculations In Clinical Research

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Sample Size Calculations In Clinical Research


Sample Size Calculations In Clinical Research
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Sample Size Calculations In Clinical Research


Sample Size Calculations In Clinical Research
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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 2017-08-15

Sample Size Calculations In Clinical Research written by Shein-Chung Chow and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-08-15 with Mathematics categories.


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
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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 2003-03-04

Sample Size Calculations In Clinical Research written by Shein-Chung Chow and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-03-04 with Mathematics categories.


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 In Clinical Research Second Edition


Sample Size Calculations In Clinical Research Second Edition
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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 2007-08-22

Sample Size Calculations In Clinical Research Second Edition written by Shein-Chung Chow and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-08-22 with Mathematics categories.


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.

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


Methods And Applications Of Sample Size Calculation And Recalculation In Clinical Trials
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Author : Meinhard Kieser
language : en
Publisher: Springer Nature
Release Date : 2020

Methods And Applications Of Sample Size Calculation And Recalculation In Clinical Trials written by Meinhard Kieser and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020 with Biometry categories.


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


Sample Size Calculations In Clinical Research
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Author : Shein-Chung Chow
language : en
Publisher: Chapman & Hall/CRC
Release Date : 2009-03-01

Sample Size Calculations In Clinical Research written by Shein-Chung Chow and has been published by Chapman & Hall/CRC this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-03-01 with Business & Economics categories.


Now in its third edition, Fundamentals of Microfabrication and Nanotechnology continues to provide the most complete MEMS coverage available. Thoroughly revised and updated the new edition of this perennial bestseller has been expanded to three volumes, reflecting the substantial growth of this field. It includes a wealth of theoretical and practical information on nanotechnology and NEMS and offers background and comprehensive information on materials, processes, and manufacturing options. The first volume offers a rigorous theoretical treatment of micro- and nanosciences, and includes sections on solid-state physics, quantum mechanics, crystallography, and fluidics. The second volume presents a very large set of manufacturing techniques for micro- and nanofabrication and covers different forms of lithography, material removal processes, and additive technologies. The third volume focuses on manufacturing techniques and applications of Bio-MEMS and Bio-NEMS. Illustrated in color throughout, this seminal work is a cogent instructional text, providing classroom and self-learners with worked-out examples and end-of-chapter problems. The author characterizes and defines major research areas and illustrates them with examples pulled from the most recent literature and from his own work.

Sample Size Calculations For Clustered And Longitudinal Outcomes In Clinical Research


Sample Size Calculations For Clustered And Longitudinal Outcomes In Clinical Research
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Author : Chul Ahn
language : en
Publisher: CRC Press
Release Date : 2014-12-09

Sample Size Calculations For Clustered And Longitudinal Outcomes In Clinical Research written by Chul Ahn and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-12-09 with Mathematics categories.


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 Sizes For Clinical Trials


Sample Sizes For Clinical Trials
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Author : Steven A. Julious
language : en
Publisher: CRC Press
Release Date : 2009-08-26

Sample Sizes For Clinical Trials written by Steven A. Julious and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-08-26 with Mathematics categories.


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.