Sample Size Calculations In Clinical Research

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Sample Size Calculations in Clinical Research

Shein-Chung Chow,Jun Shao,Hansheng Wang,Yuliya Lokhnygina
Sample Size Calculations in Clinical Research Book PDF

Author : Shein-Chung Chow,Jun Shao,Hansheng Wang,Yuliya Lokhnygina
Publisher : CRC Press
Page : 954 pages
File Size : 45,9 Mb
Release : 2017-08-15
Category : Mathematics
ISBN : 9781351727112

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Sample Size Calculations in Clinical Research by Shein-Chung Chow,Jun Shao,Hansheng Wang,Yuliya Lokhnygina Pdf

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

Shein-Chung Chow,Hansheng Wang,Jun Shao
Sample Size Calculations in Clinical Research Book PDF

Author : Shein-Chung Chow,Hansheng Wang,Jun Shao
Publisher : CRC Press
Page : 376 pages
File Size : 44,9 Mb
Release : 2003-03-04
Category : Mathematics
ISBN : 0203911342

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Sample Size Calculations in Clinical Research by Shein-Chung Chow,Hansheng Wang,Jun Shao Pdf

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

Shein-Chung Chow,Hansheng Wang,Jun Shao
Sample Size Calculations in Clinical Research Second Edition Book PDF

Author : Shein-Chung Chow,Hansheng Wang,Jun Shao
Publisher : CRC Press
Page : 481 pages
File Size : 44,7 Mb
Release : 2007-08-22
Category : Mathematics
ISBN : 9781439870938

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Sample Size Calculations in Clinical Research, Second Edition by Shein-Chung Chow,Hansheng Wang,Jun Shao Pdf

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 for Clustered and Longitudinal Outcomes in Clinical Research

Chul Ahn,Moonseoung Heo,Song Zhang
Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research Book PDF

Author : Chul Ahn,Moonseoung Heo,Song Zhang
Publisher : CRC Press
Page : 262 pages
File Size : 52,5 Mb
Release : 2014-12-09
Category : Mathematics
ISBN : 9781466556263

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Sample Size Calculations for Clustered and Longitudinal Outcomes in Clinical Research by Chul Ahn,Moonseoung Heo,Song Zhang Pdf

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

Steven A. Julious
Sample Sizes for Clinical Trials Book PDF

Author : Steven A. Julious
Publisher : CRC Press
Page : 330 pages
File Size : 43,8 Mb
Release : 2009-08-26
Category : Mathematics
ISBN : 9781584887409

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Sample Sizes for Clinical Trials by Steven A. Julious Pdf

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

Shein-Chung Chow,Jun Shao,Hansheng Wang,Yuliya Lokhnygina
Sample Size Calculations in Clinical Research Book PDF

Author : Shein-Chung Chow,Jun Shao,Hansheng Wang,Yuliya Lokhnygina
Publisher : CRC Press
Page : 510 pages
File Size : 44,9 Mb
Release : 2017-08-15
Category : Mathematics
ISBN : 9781351727129

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Sample Size Calculations in Clinical Research by Shein-Chung Chow,Jun Shao,Hansheng Wang,Yuliya Lokhnygina Pdf

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

Shein-Chung Chow
Sample Size Calculations in Clinical Research Book PDF

Author : Shein-Chung Chow
Publisher : Chapman & Hall/CRC
Page : 0 pages
File Size : 54,9 Mb
Release : 2017
Category : Clinical medicine
ISBN : 1138740985

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Sample Size Calculations in Clinical Research by Shein-Chung Chow Pdf

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.

Sample Size Tables for Clinical Studies

David Machin,Michael J. Campbell,Say Beng Tan,Sze Huey Tan
Sample Size Tables for Clinical Studies Book PDF

Author : David Machin,Michael J. Campbell,Say Beng Tan,Sze Huey Tan
Publisher : John Wiley & Sons
Page : 319 pages
File Size : 42,6 Mb
Release : 2011-08-26
Category : Medical
ISBN : 9781444357967

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Sample Size Tables for Clinical Studies by David Machin,Michael J. Campbell,Say Beng Tan,Sze Huey Tan Pdf

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.

Practical Statistics for Medical Research

Douglas G. Altman
Practical Statistics for Medical Research Book PDF

Author : Douglas G. Altman
Publisher : CRC Press
Page : 624 pages
File Size : 44,5 Mb
Release : 1990-11-22
Category : Mathematics
ISBN : 9781000228816

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Practical Statistics for Medical Research by Douglas G. Altman Pdf

Practical Statistics for Medical Research is a problem-based text for medical researchers, medical students, and others in the medical arena who need to use statistics but have no specialized mathematics background. The author draws on twenty years of experience as a consulting medical statistician to provide clear explanations to key statistical concepts, with a firm emphasis on practical aspects of designing and analyzing medical research. Using real data and including dozens of interesting data sets, this bestselling text gives special attention to the presentation and interpretation of results and the many real problems that arise in medical research.

Sample Size Calculations

Paul Mathews
Sample Size Calculations Book PDF

Author : Paul Mathews
Publisher : Mathews Malnar and Bailey
Page : 341 pages
File Size : 46,9 Mb
Release : 2010
Category : Mathematics
ISBN : 9780615324616

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Sample Size Calculations by Paul Mathews Pdf

Sample Size Calculations: Practical Methods for Engineers and Scientists presents power and sample size calculations for common statistical analyses including methods for means, standard deviations, proportions, counts, regression, correlation, and measures of agreement. Topics of special interest to quality engineering professionals include designed experiments, reliability studies, statistical process control, acceptance sampling, process capability analysis, statistical tolerancing, and gage error studies. The book emphasizes approximate methods, but exact methods are presented when the approximate methods fail. Monte Carlo and bootstrap methods are introduced for situations that don't satisfy the assumptions of the analytical methods. Solutions are presented for more than 170 example problems and solutions for selected example problems using PASS, MINITAB, Piface, and R are posted on the Internet.

Sample Size Determination in Clinical Trials with Multiple Endpoints

Takashi Sozu,Tomoyuki Sugimoto,Toshimitsu Hamasaki,Scott R. Evans
Sample Size Determination in Clinical Trials with Multiple Endpoints Book PDF

Author : Takashi Sozu,Tomoyuki Sugimoto,Toshimitsu Hamasaki,Scott R. Evans
Publisher : Springer
Page : 95 pages
File Size : 48,8 Mb
Release : 2015-08-20
Category : Mathematics
ISBN : 9783319220055

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Sample Size Determination in Clinical Trials with Multiple Endpoints by Takashi Sozu,Tomoyuki Sugimoto,Toshimitsu Hamasaki,Scott R. Evans Pdf

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.

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

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

Author : Agency for Health Care Research and Quality (U.S.)
Publisher : Government Printing Office
Page : 204 pages
File Size : 40,7 Mb
Release : 2013-02-21
Category : Medical
ISBN : 9781587634239

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

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 Sizes for Clinical Trials

Steven A. Julious
Sample Sizes for Clinical Trials Book PDF

Author : Steven A. Julious
Publisher : CRC Press
Page : 421 pages
File Size : 55,5 Mb
Release : 2023-06-21
Category : Medical
ISBN : 9780429994555

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Sample Sizes for Clinical Trials by Steven A. Julious Pdf

Features: Comprehensive coverage of sample size calculations, including Normal, binary, ordinal, and survival outcome data Covers superiority, equivalence, non-inferiority, bioequivalence and precision objectives for both parallel group and crossover designs Highlights how trial objectives impact the study design with respect to both the derivation of sample formulae and the size of the study Motivated with examples of real-life clinical trials showing how the calculations can be applied New edition is extended with all chapters revised, some substantially, and four completely new chapters on multiplicity, cluster trials, pilot studies, and single arm trials

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

Meinhard Kieser
Methods and Applications of Sample Size Calculation and Recalculation in Clinical Trials Book PDF

Author : Meinhard Kieser
Publisher : Springer Nature
Page : 391 pages
File Size : 42,9 Mb
Release : 2020-11-19
Category : Mathematics
ISBN : 9783030495282

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Methods and Applications of Sample Size Calculation and Recalculation in Clinical Trials by Meinhard Kieser Pdf

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 Determination and Power

Thomas P. Ryan
Sample Size Determination and Power Book PDF

Author : Thomas P. Ryan
Publisher : John Wiley & Sons
Page : 230 pages
File Size : 41,6 Mb
Release : 2013-05-28
Category : Medical
ISBN : 9781118439227

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Sample Size Determination and Power by Thomas P. Ryan Pdf

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.