Crossover Designs

Author: Kung-Jong Lui
Publisher: John Wiley & Sons
ISBN: 1119114683
Size: 20.60 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.

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

Author: Michael J. Campbell
Publisher: John Wiley & Sons
ISBN: 1118763602
Size: 60.59 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.

Wylie Churchill Davidson S A Practice Of Anesthesia 7th Edition

Author: Thomas EJ Healy
Publisher: CRC Press
ISBN: 1444114026
Size: 27.19 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.

Small Clinical Trials

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 9780309171144
Size: 44.42 MB
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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.

Statistics With Confidence

Author: Douglas Altman
Publisher: John Wiley & Sons
ISBN: 1118702506
Size: 64.84 MB
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This highly popular introduction to confidence intervals has been thoroughly updated and expanded. It includes methods for using confidence intervals, with illustrative worked examples and extensive guidelines and checklists to help the novice.

Biostatistics For Medical And Biomedical Practitioners

Author: Julien I. E. Hoffman
Publisher: Academic Press
ISBN: 0128026073
Size: 75.78 MB
Format: PDF
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Biostatistics for Practitioners: An Interpretative Guide for Medicine and Biology deals with several aspects of statistics that are indispensable for researchers and students across the biomedical sciences. The book features a step-by-step approach, focusing on standard statistical tests, as well as discussions of the most common errors. The book is based on the author’s 40+ years of teaching statistics to medical fellows and biomedical researchers across a wide range of fields. Discusses how to use the standard statistical tests in the biomedical field, as well as how to make statistical inferences (t test, ANOVA, regression etc.) Includes non-standards tests, including equivalence or non-inferiority testing, extreme value statistics, cross-over tests, and simple time series procedures such as the runs test and Cusums Introduces procedures such as multiple regression, Poisson regression, meta-analysis and resampling statistics, and provides references for further studies

Design And Analysis Of Cross Over Trials Third Edition

Author: Byron Jones
Publisher: CRC Press
ISBN: 1439861420
Size: 64.92 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
Publisher: Lippincott Williams & Wilkins
ISBN: 1469840545
Size: 65.28 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.

Encyclopedia Of Research Design

Author: Neil J. Salkind
Publisher: SAGE
ISBN: 1412961270
Size: 29.26 MB
Format: PDF, ePub
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"Comprising more than 500 entries, the Encyclopedia of Research Design explains how to make decisions about research design, undertake research projects in an ethical manner, interpret and draw valid inferences from data, and evaluate experiment design strategies and results. Two additional features carry this encyclopedia far above other works in the field: bibliographic entries devoted to significant articles in the history of research design and reviews of contemporary tools, such as software and statistical procedures, used to analyze results. It covers the spectrum of research design strategies, from material presented in introductory classes to topics necessary in graduate research; it addresses cross- and multidisciplinary research needs, with many examples drawn from the social and behavioral sciences, neurosciences, and biomedical and life sciences; it provides summaries of advantages and disadvantages of often-used strategies; and it uses hundreds of sample tables, figures, and equations based on real-life cases."--Publisher's description.

Oncology Clinical Trials

Author: Susan Halabi, PhD
Publisher: Demos Medical Publishing
ISBN: 9781935281764
Size: 16.84 MB
Format: PDF
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Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial. Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials. Oncology Clinical Trials features: A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis Real-life examples from reported clinical trials included throughout