crossover designs testing estimation and sample size statistics in practice

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Crossover Designs

Author : Kung-Jong Lui
ISBN : 9781119114680
Genre : Mathematics
File Size : 31. 46 MB
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Crossover Designs: Testing, Estimation and Sample Size Kung-Jong Lui, Department of Mathematics and Statistics, San Diego State University, USA A comprehensive and practical resource for analyses of crossover designs For ethical reasons, it is vital to keep the number of patients in a clinical trial as low as possible. As evidenced by extensive research publications, crossover design can be a useful and powerful tool to reduce the number of patients needed for a parallel group design in studying treatments for non-curable chronic diseases. This book introduces commonly-used and well-established statistical tests and estimators in epidemiology that can easily be applied to hypothesis testing and estimation of the relative treatment effect for various types of data scale in crossover designs. Models with distribution-free random effects are assumed and hence most approaches considered here are semi-parametric. The book provides clinicians and biostatisticians with the exact test procedures and exact interval estimators, which are applicable even when the number of patients in a crossover trial is small. Systematic discussion on sample size determination is also included, which will be a valuable resource for researchers involved in crossover trial design. Key features: l Provides exact test procedures and interval estimators, which are especially of use in small-sample cases. l Presents most test procedures and interval estimators in closed-forms, enabling readers to calculate them by use of a pocket calculator or commonly-used statistical packages. l Each chapter is self-contained, allowing the book to be used a reference resource. l Uses real-life examples to illustrate the practical use of test procedures and estimators l Provides extensive exercises to help readers appreciate the underlying theory, learn other relevant test procedures and understand how to calculate the required sample size. Crossover Designs: Testing, Estimation and Sample Size will be a useful resource for researchers from biostatistics, as well as pharmaceutical and clinical sciences. It can also be used as a textbook or reference for graduate students studying clinical experiments.

Sample Size Calculations In Clinical Research Third Edition

Author : Shein-Chung Chow
ISBN : 9781351727112
Genre : Mathematics
File Size : 41. 8 MB
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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. ?

Small Clinical Trials

Author : Institute of Medicine
ISBN : 0309171148
Genre : Medical
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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.

Wylie Churchill Davidson S A Practice Of Anesthesia 7th Edition

Author : Thomas EJ Healy
ISBN : 9781444114027
Genre : Medical
File Size : 38. 99 MB
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The new edition of this popular text has been extensively revised and updated throughout. It will continue to provide the trainee or practising anesthetist with all the information, both background and practical, that will be needed in the busy clinical setting or during revision for qualifying examinations. Major changes for the new edition include increased international relevance, made possible by the extensive input of a new American co-editor and the selection of well known contributing authors from around the world. The content is thus applicable to all trainees studying for, and passing, the variety of different certifying examinations for practising anesthesia in a wide range of locales. The book presents both the basic science underlying modern anesthetic practice and up-to-date clinical anesthetic management techniques in a comprehensive, but concise and accessible, style. Reviews are well referenced throughout to guide the reader towards additional information beyond the scope of this text. The book will continue to provide in a single volume all the information relevant to the physician in training, and serve as a convenient and reliable reference for the anaesthetist to use after training.

Applied Statistical Methods

Author : Irving W. Burr
ISBN : 9781483277868
Genre : Mathematics
File Size : 54. 55 MB
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Applied Statistical Methods covers the fundamental understanding of statistical methods necessary to deal with a wide variety of practical problems. This 14-chapter text presents the topics covered in a manner that stresses clarity of understanding, interpretation, and method of application. The introductory chapter illustrates the importance of statistical analysis. The next chapters introduce the methods of data summarization, including frequency distributions, cumulative frequency distributions, and measures of central tendency and variability. These topics are followed by discussions of the fundamental principles of probability, the concepts of sample spaces, outcomes, events, probability, independence of events, and the characterization of discrete and continuous random variables. Other chapters explore the distribution of several important statistics; statistical tests of hypotheses; point and interval estimation; and simple linear regression. The concluding chapters review the elements of single- and two-factor analysis of variance and the design of analysis of variance experiments. This book is intended primarily for advanced undergraduate and graduate students in the mathematical, physical, and engineering sciences, as well as in economics, business, and related areas. Researchers and line personnel in industry and government will find this book useful in self-study.

How To Design Analyse And Report Cluster Randomised Trials In Medicine And Health Related Research

Author : Michael J. Campbell
ISBN : 9781118763605
Genre : Medical
File Size : 87. 97 MB
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A complete guide to understanding cluster randomised trials Written by two researchers with extensive experience in the field, this book presents a complete guide to the design, analysis and reporting of cluster randomised trials. It spans a wide range of applications: trials in developing countries, trials in primary care, trials in the health services. A key feature is the use of R code and code from other popular packages to plan and analyse cluster trials, using data from actual trials. The book contains clear technical descriptions of the models used, and considers in detail the ethics involved in such trials and the problems in planning them. For readers and students who do not intend to run a trial but wish to be a critical reader of the literature, there are sections on the CONSORT statement, and exercises in reading published trials. Written in a clear, accessible style Features real examples taken from the authors’ extensive practitioner experience of designing and analysing clinical trials Demonstrates the use of R, Stata and SPSS for statistical analysis Includes computer code so the reader can replicate all the analyses Discusses neglected areas such as ethics and practical issues in running cluster randomised trials How to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research provides an excellent reference tool and can be read with profit by statisticians, health services researchers, systematic reviewers and critical readers of cluster randomised trials.

Design And Analysis Of Cross Over Trials Third Edition

Author : Byron Jones
ISBN : 9781439861424
Genre : Mathematics
File Size : 37. 24 MB
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Design and Analysis of Cross-Over Trials is concerned with a specific kind of comparative trial known as the cross-over trial, in which subjects receive different sequences of treatments. Such trials are widely used in clinical and medical research, and in other diverse areas such as veterinary science, psychology, sports science, and agriculture. The first edition of this book was the first to be wholly devoted to the subject. The second edition was revised to mirror growth and development in areas where the design remained in widespread use and new areas where it had grown in importance. This new Third Edition: Contains seven new chapters written in the form of short case studies that address re-estimating sample size when testing for average bioequivalence, fitting a nonlinear dose response function, estimating a dose to take forward from phase two to phase three, establishing proof of concept, and recalculating the sample size using conditional power Employs the R package Crossover, specially created to accompany the book and provide a graphical user interface for locating designs in a large catalog and for searching for new designs Includes updates regarding the use of period baselines and the analysis of data from very small trials Reflects the availability of new procedures in SAS, particularly proc glimmix Presents the SAS procedure proc mcmc as an alternative to WinBUGS for Bayesian analysis Complete with real data and downloadable SAS code, Design and Analysis of Cross-Over Trials, Third Edition provides a practical understanding of the latest methods along with the necessary tools for implementation.

Designing Clinical Research

Author : Stephen B. Hulley
ISBN : 9781469840543
Genre : Medical
File Size : 72. 31 MB
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Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This product incorporates current research methodology--including molecular and genetic clinical research--and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing.

Bayesian Approaches To Clinical Trials And Health Care Evaluation

Author : David J. Spiegelhalter
ISBN : 0471499757
Genre : Mathematics
File Size : 72. 26 MB
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The Bayesian approach involves collecting data from past experience in order to reach conclusions about future events. This introduction covers a broad array of topics. It is for statisticians in the pharmaceutical industry, as well as anyone involved in conducting clinical trials and HTA work.

Cross Over Trials In Clinical Research

Author : Stephen S. Senn
ISBN : 9780470854587
Genre : Mathematics
File Size : 38. 98 MB
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Cross-over trials are an important class of design used in the pharmaceutical industry and medical research, and their use continues to grow. Cross-over Trials in Clinical Research, Second Edition has been fully updated to include the latest methodology used in the design and analysis of cross-over trials. It includes more background material, greater coverage of important statistical techniques, including Bayesian methods, and discussion of analysis using a number of statistical software packages. * Comprehensive coverage of the design and analysis of cross-over trials. * Each technique is carefully explained and the mathematics is kept to a minimum. * Features many real and original examples, taken from the author's vast experience. * Includes discussion of analysis using SAS, S-Plus and, GenStat, StatXact and Excel. * Written in a style suitable for statisticians and physicians alike. * Computer programs to accompany the examples in the book can be downloaded from the Web Primarily aimed at statisticians and researchers working in the pharmaceutical industry, the book will also appeal to physicians involved in clinical research and students of medical statistics.

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