Sample Size Calculations In Clinical Research

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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 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 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 Calculations in Clinical Research

Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 9780203911341
Total Pages : 376 pages
Book Rating : 4.9/5 (113 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 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 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 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 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 Size Calculations

Author : Paul Mathews
Publisher : Mathews Malnar and Bailey
ISBN 13 : 0615324614
Total Pages : 341 pages
Book Rating : 4.6/5 (153 download)

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Book Synopsis Sample Size Calculations by : Paul Mathews

Download or read book Sample Size Calculations written by Paul Mathews and published by Mathews Malnar and Bailey. This book was released on 2010 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 Calculations in Clinical Research

Author : Shein-Chung Chow
Publisher : Chapman & Hall/CRC
ISBN 13 : 9781138740983
Total Pages : 0 pages
Book Rating : 4.7/5 (49 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 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

Author : Agency for Health Care Research and Quality (U.S.)
Publisher : Government Printing Office
ISBN 13 : 1587634236
Total Pages : 204 pages
Book Rating : 4.5/5 (876 download)

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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)

Practical Statistics for Medical Research

Author : Douglas G. Altman
Publisher : CRC Press
ISBN 13 : 1000228819
Total Pages : 624 pages
Book Rating : 4.0/5 (2 download)

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Book Synopsis Practical Statistics for Medical Research by : Douglas G. Altman

Download or read book Practical Statistics for Medical Research written by Douglas G. Altman and published by CRC Press. This book was released on 1990-11-22 with total page 624 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Adequacy of Sample Size in Health Studies

Author : Stanley Lemeshow
Publisher : Wiley
ISBN 13 : 9780471925170
Total Pages : 252 pages
Book Rating : 4.9/5 (251 download)

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Book Synopsis Adequacy of Sample Size in Health Studies by : Stanley Lemeshow

Download or read book Adequacy of Sample Size in Health Studies written by Stanley Lemeshow and published by Wiley. This book was released on 1990-01-14 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: Practical rather than theoretical, it provides epidemiologists and other health workers with a good basic knowledge of sampling principles and methods and their potential in the medical field. Focusing on the determination of adequate sample sizes under different situations, the book is divided into two parts; the first provides solutions to typical problems of various survey and study designs, and the second offers a clear, concise exposition of the theory behind the processes of determining sample size. Features many reference tables.

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.

Field Trials of Health Interventions

Author : Peter G. Smith
Publisher : Oxford University Press, USA
ISBN 13 : 0198732864
Total Pages : 479 pages
Book Rating : 4.1/5 (987 download)

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Book Synopsis Field Trials of Health Interventions by : Peter G. Smith

Download or read book Field Trials of Health Interventions written by Peter G. Smith and published by Oxford University Press, USA. This book was released on 2015 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: "IEA, International Epidemiological Association, Welcome Trust."

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 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.

Small Clinical Trials

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 9780309171144
Total Pages : 222 pages
Book Rating : 4.1/5 (711 download)

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Book Synopsis Small Clinical Trials by : Institute of Medicine

Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.