Sample Size Calculations In Clinical Research
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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
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Author : Meinhard Kieser
language : en
Publisher: Springer Nature
Release Date : 2020-11-19
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 2020-11-19 with Mathematics 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 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 su
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 Tables For Clinical Studies
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Author : David Machin
language : en
Publisher: John Wiley & Sons
Release Date : 2011-08-26
Sample Size Tables For Clinical Studies written by David Machin and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-08-26 with Medical categories.
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
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Author : Douglas G. Altman
language : en
Publisher: CRC Press
Release Date : 1990-11-22
Practical Statistics For Medical Research written by Douglas G. Altman and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1990-11-22 with Mathematics categories.
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.
Developing A Protocol For Observational Comparative Effectiveness Research A User S Guide
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Author : Agency for Health Care Research and Quality (U.S.)
language : en
Publisher: Government Printing Office
Release Date : 2013-02-21
Developing A Protocol For Observational Comparative Effectiveness Research A User S Guide written by Agency for Health Care Research and Quality (U.S.) and has been published by Government Printing Office this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-02-21 with Medical categories.
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 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
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Author : Paul Mathews
language : en
Publisher: Mathews Malnar and Bailey
Release Date : 2010
Sample Size Calculations written by Paul Mathews and has been published by Mathews Malnar and Bailey this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with Mathematics categories.
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 And Power
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Author : Thomas P. Ryan
language : en
Publisher: John Wiley & Sons
Release Date : 2013-05-28
Sample Size Determination And Power written by Thomas P. Ryan and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-05-28 with Medical categories.
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.