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Sample Sizes For Clinical Trials

Author: Steven A. Julious
Publisher: CRC Press
ISBN: 9781584887409
Size: 68.28 MB
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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 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 Tables For Clinical Studies

Author: David Machin
Publisher: John Wiley & Sons
ISBN: 1444357964
Size: 55.86 MB
Format: PDF, ePub
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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
Publisher: CRC Press
ISBN: 1351727117
Size: 52.62 MB
Format: PDF, ePub
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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.

Crc Handbook Of Sample Size Guidelines For Clinical Trials

Author: Jonathan J. Shuster
Publisher: CRC Press
ISBN: 9780849335426
Size: 67.71 MB
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The aim of this unique volume is to help medical researchers design clinical trials to improve survival, remission duration, or time to recurrence of disease. Written in a user-friendly step-by-step format, this work enables the researcher-with no background in statistics-to determine sample size and write statistical considerations for their protocols. It provides critical language which can help with FDA submissions and/or research grants. It also provides the mathematical justification of the material at a level consistent with one year of undergraduate mathematical statistics. It presents survival analysis methods at a more elementary level than any known text. Filled with tables, figures, plus an extensive appendix, this one-of-a-kind reference is an absolute must for all clinical researchers and biostatisticians.

Sample Size Calculations In Clinical Research Second Edition

Author: Shein-Chung Chow
Publisher: CRC Press
ISBN: 1439870934
Size: 77.81 MB
Format: PDF, Kindle
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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 Sizes For Clinical Laboratory And Epidemiology Studies

Author: David Machin
Publisher: John Wiley & Sons
ISBN: 1118874935
Size: 40.45 MB
Format: PDF, ePub
View: 1982
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An authoritative resource that offers the statistical tools and software needed to design and plan valid clinical studies Now in its fourth and extended edition, Sample Sizes for Clinical, Laboratory and Epidemiology Studiesincludes the sample size software (SSS) and formulae and numerical tables needed to design valid clinical studies. The text covers clinical as well as laboratory and epidemiology studies and contains the information needed to ensure a study will form a valid contribution to medical research. The authors, noted experts in the field, explain step by step and explore the wide range of considerations necessary to assist investigational teams when deriving an appropriate sample size for their when planned study. The book contains sets of sample size tables with companion explanations and clear worked out examples based on real data. In addition, the text offers bibliography and references sections that are designed to be helpful with guidance on the principles discussed. This revised fourth edition: Offers the only text available to include sample size software for use in designing and planning clinical studies Presents new and extended chapters with many additional and refreshed examples Includes clear explanations of the principles and methodologies involved with relevant practical examples Makes clear a complex but vital topic that is designed to ensure valid methodology and publishable results Contains guidance from an internationally recognised team of medical statistics experts Written for medical researchers from all specialities and medical statisticians, Sample Sizes for Clinical, Laboratory and EpidemiologyStudies offers an updated fourth edition of the important guide for designing and planning reliable and evidence based clinical studies.

Fundamentals Of Clinical Trials

Author: Lawrence M. Friedman
Publisher: Springer Science & Business Media
ISBN: 9781441915863
Size: 52.17 MB
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The clinical trial is “the most definitive tool for evaluation of the applicability of clinical research.” It represents “a key research activity with the potential to improve the quality of health care and control costs through careful comparison of alternative treatments” [1]. It has been called on many occasions, “the gold st- dard” against which all other clinical research is measured. Although many clinical trials are of high quality, a careful reader of the medical literature will notice that a large number have deficiencies in design, conduct, analysis, presentation, and/or interpretation of results. Improvements have occurred over the past few decades, but too many trials are still conducted without adequate attention to its fundamental principles. Certainly, numerous studies could have been upgraded if the authors had had a better understanding of the fundamentals. Since the publication of the first edition of this book, a large number of other texts on clinical trials have appeared, most of which are indicated here [2–21]. Several of them, however, discuss only specific issues involved in clinical trials. Additionally, many are no longer current. The purpose of this fourth edition is to update areas in which major progress has been made since the publication of the third edition. We have revised most chapters considerably and added one on ethical issues.

Sample Size Calculations For Clustered And Longitudinal Outcomes In Clinical Research

Author: Chul Ahn
Publisher: CRC Press
ISBN: 1466556269
Size: 34.13 MB
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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 Size Determination And Power

Author: Thomas P. Ryan
Publisher: John Wiley & Sons
ISBN: 1118439228
Size: 56.29 MB
Format: PDF, ePub, Docs
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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.