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Introduction To Statistical Methods For Clinical Trials

Author: Thomas D. Cook
Publisher: CRC Press
ISBN: 1584880279
Size: 37.78 MB
Format: PDF
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Clinical trials have become essential research tools for evaluating the benefits and risks of new interventions for the treatment and prevention of diseases, from cardiovascular disease to cancer to AIDS. Based on the authors’ collective experiences in this field, Introduction to Statistical Methods for Clinical Trials presents various statistical topics relevant to the design, monitoring, and analysis of a clinical trial. After reviewing the history, ethics, protocol, and regulatory issues of clinical trials, the book provides guidelines for formulating primary and secondary questions and translating clinical questions into statistical ones. It examines designs used in clinical trials, presents methods for determining sample size, and introduces constrained randomization procedures. The authors also discuss how various types of data must be collected to answer key questions in a trial. In addition, they explore common analysis methods, describe statistical methods that determine what an emerging trend represents, and present issues that arise in the analysis of data. The book concludes with suggestions for reporting trial results that are consistent with universal guidelines recommended by medical journals. Developed from a course taught at the University of Wisconsin for the past 25 years, this textbook provides a solid understanding of the statistical approaches used in the design, conduct, and analysis of clinical trials.

Introduction To Randomized Controlled Clinical Trials Second Edition

Author: John N.S. Matthews
Publisher: CRC Press
ISBN: 1420011308
Size: 49.70 MB
Format: PDF, ePub
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Evidence from randomized controlled clinical trials is widely accepted as the only sound basis for assessing the efficacy of new medical treatments. Statistical methods play a key role in all stages of these trials, including their justification, design, and analysis. This second edition of Introduction to Randomized Controlled Clinical Trials provides a concise presentation of the principles applied in this area. It details the concepts behind randomization and methods for designing and analyzing trials and also includes information on meta-analysis and specialized designs, such as cross-over trials, cluster-randomized designs, and equivalence studies. This latest edition features new and revised references, examples, exercises, and a new chapter dedicated to binary outcomes and survival analysis. It also presents numerous examples taken from the medical literature, contains exercises at the end of each chapter, and offers solutions in an appendix. The author uses Minitab and R software throughout the text for implementing the methods that are presented. Comprehensive and accessible, Introduction to Randomized Controlled Clinical Trials is well-suited for those familiar with elementary statistical ideas and methods who want to further their knowledge of the subject.

Statistical Design And Analysis Of Clinical Trials

Author: Weichung Joe Shih
Publisher: CRC Press
ISBN: 1482250500
Size: 32.81 MB
Format: PDF, ePub, Mobi
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Statistical Design and Analysis of Clinical Trials: Principles and Methods concentrates on the biostatistics component of clinical trials. Developed from the authors’ courses taught to public health and medical students, residents, and fellows during the past 15 years, the text shows how biostatistics in clinical trials is an integration of many fundamental scientific principles and statistical methods. Teach Your Students How to Design, Monitor, and Analyze Clinical Trials The book begins with ethical and safety principles, core trial design concepts, the principles and methods of sample size and power calculation, and analysis of covariance and stratified analysis. It then focuses on sequential designs and methods for two-stage Phase II cancer trials to Phase III group sequential trials, covering monitoring safety, futility, and efficacy. The authors also discuss the development of sample size reestimation and adaptive group sequential procedures, explain the concept of different missing data processes, and describe how to analyze incomplete data by proper multiple imputations. Turn Your Students into Better Clinical Trial Investigators This text reflects the academic research, commercial development, and public health aspects of clinical trials. It gives students a multidisciplinary understanding of the concepts and techniques involved in designing and analyzing various types of trials. The book’s balanced set of homework assignments and in-class exercises are appropriate for students in (bio)statistics, epidemiology, medicine, pharmacy, and public health.

Understanding Advanced Statistical Methods

Author: Peter Westfall
Publisher: CRC Press
ISBN: 1466512105
Size: 15.73 MB
Format: PDF, Mobi
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Providing a much-needed bridge between elementary statistics courses and advanced research methods courses, Understanding Advanced Statistical Methods helps students grasp the fundamental assumptions and machinery behind sophisticated statistical topics, such as logistic regression, maximum likelihood, bootstrapping, nonparametrics, and Bayesian methods. The book teaches students how to properly model, think critically, and design their own studies to avoid common errors. It leads them to think differently not only about math and statistics but also about general research and the scientific method. With a focus on statistical models as producers of data, the book enables students to more easily understand the machinery of advanced statistics. It also downplays the "population" interpretation of statistical models and presents Bayesian methods before frequentist ones. Requiring no prior calculus experience, the text employs a "just-in-time" approach that introduces mathematical topics, including calculus, where needed. Formulas throughout the text are used to explain why calculus and probability are essential in statistical modeling. The authors also intuitively explain the theory and logic behind real data analysis, incorporating a range of application examples from the social, economic, biological, medical, physical, and engineering sciences. Enabling your students to answer the why behind statistical methods, this text teaches them how to successfully draw conclusions when the premises are flawed. It empowers them to use advanced statistical methods with confidence and develop their own statistical recipes. Ancillary materials are available on the book’s website.

Introduction To Statistics In Pharmaceutical Clinical Trials

Author: Todd A. Durham
Publisher:
ISBN: 9780853697145
Size: 53.21 MB
Format: PDF, Docs
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All students of pharmaceutical sciences and clinical research need a solid knowledge and understanding of the nature, methods, application, and importance of statistics. Introduction to Statistics in Pharmaceutical Clinical Trials is an ideal introduction to statistics presented in the context of clinical trials conducted during pharmaceutical drug development. This novel approach both teaches the computational steps needed to conduct analyses and provides a conceptual understanding of how these analyses provide information that forms the rational basis for decision making throughout the drug development process.

Clinical Trials

Author: Steven Piantadosi
Publisher: John Wiley & Sons
ISBN: 1118959213
Size: 20.91 MB
Format: PDF, ePub, Mobi
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Presents elements of clinical trial methods that are essential in planning, designing, conducting, analyzing, and interpreting clinical trials with the goal of improving the evidence derived from these important studies This Third Edition builds on the text’s reputation as a straightforward, detailed, and authoritative presentation of quantitative methods for clinical trials. Readers will encounter the principles of design for various types of clinical trials, and are then skillfully guided through the complete process of planning the experiment, assembling a study cohort, assessing data, and reporting results. Throughout the process, the author alerts readers to problems that may arise during the course of the trial and provides common sense solutions. All stages of therapeutic development are discussed in detail, and the methods are not restricted to a single clinical application area. The authors bases current revisions and updates on his own experience, classroom instruction, and feedback from teachers and medical and statistical professionals involved in clinical trials. The Third Edition greatly expands its coverage, ranging from statistical principles to new and provocative topics, including alternative medicine and ethics, middle development, comparative studies, and adaptive designs. At the same time, it offers more pragmatic advice for issues such as selecting outcomes, sample size, analysis, reporting, and handling allegations of misconduct. Readers familiar with the First and Second Editions will discover revamped exercise sets; an updated and extensive reference section; new material on endpoints and the developmental pipeline, among others; and revisions of numerous sections. In addition, this book: • Features accessible and broad coverage of statistical design methods—the crucial building blocks of clinical trials and medical research -- now complete with new chapters on overall development, middle development, comparative studies, and adaptive designs • Teaches readers to design clinical trials that produce valid qualitative results backed by rigorous statistical methods • Contains an introduction and summary in each chapter to reinforce key points • Includes discussion questions to stimulate critical thinking and help readers understand how they can apply their newfound knowledge • Provides extensive references to direct readers to the most recent literature, and there are numerous new or revised exercises throughout the book Clinical Trials: A Methodologic Perspective, Third Edition is a textbook accessible to advanced undergraduate students in the quantitative sciences, graduate students in public health and the life sciences, physicians training in clinical research methods, and biostatisticians and epidemiologists. Steven Piantadosi, MD, PhD, is the Phase One Foundation Distinguished Chair and Director of the Samuel Oschin Cancer Institute, and Professor of Medicine at Cedars-Sinai Medical Center in Los Angeles, California. Dr. Piantadosi is one of the world’s leading experts in the design and analysis of clinical trials for cancer research. He has taught clinical trials methods extensively in formal courses and short venues. He has advised numerous academic programs and collaborations nationally regarding clinical trial design and conduct, and has served on external advisory boards for the National Institutes of Health and other prominent cancer programs and centers. The author of more than 260 peer-reviewed scientific articles, Dr. Piantadosi has published extensively on research results, clinical applications, and trial methodology. While his papers have contributed to many areas of oncology, he has also collaborated on diverse studies outside oncology including lung disease and degenerative neurological disease.

Practical Statistics For Medical Research

Author: Douglas G. Altman
Publisher: CRC Press
ISBN: 9780412276309
Size: 35.36 MB
Format: PDF, ePub, Mobi
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Most medical researchers, whether clinical or non-clinical, receive some background in statistics as undergraduates. However, it is most often brief, a long time ago, and largely forgotten by the time it is needed. Furthermore, many introductory texts fall short of adequately explaining the underlying concepts of statistics, and often are divorced from the reality of conducting and assessing medical research. 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. The text gives special attention to the presentation and interpretation of results and the many real problems that arise in medical research.

Introduction To Statistical Process Control

Author: Peihua Qiu
Publisher: CRC Press
ISBN: 1439847991
Size: 65.77 MB
Format: PDF, ePub, Mobi
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A major tool for quality control and management, statistical process control (SPC) monitors sequential processes, such as production lines and Internet traffic, to ensure that they work stably and satisfactorily. Along with covering traditional methods, Introduction to Statistical Process Control describes many recent SPC methods that improve upon the more established techniques. The author—a leading researcher on SPC—shows how these methods can handle new applications. After exploring the role of SPC and other statistical methods in quality control and management, the book covers basic statistical concepts and methods useful in SPC. It then systematically describes traditional SPC charts, including the Shewhart, CUSUM, and EWMA charts, as well as recent control charts based on change-point detection and fundamental multivariate SPC charts under the normality assumption. The text also introduces novel univariate and multivariate control charts for cases when the normality assumption is invalid and discusses control charts for profile monitoring. All computations in the examples are solved using R, with R functions and datasets available for download on the author’s website. Offering a systematic description of both traditional and newer SPC methods, this book is ideal as a primary textbook for a one-semester course in disciplines concerned with process quality control, such as statistics, industrial and systems engineering, and management sciences. It can also be used as a supplemental textbook for courses on quality improvement and system management. In addition, the book provides researchers with many useful, recent research results on SPC and gives quality control practitioners helpful guidelines on implementing up-to-date SPC techniques.

Clinical Trial Data Analysis Using R And Sas

Author: Ding-Geng (Din) Chen
Publisher: CRC Press
ISBN: 1351651145
Size: 14.10 MB
Format: PDF, Mobi
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Review of the First Edition "The goal of this book, as stated by the authors, is to fill the knowledge gap that exists between developed statistical methods and the applications of these methods. Overall, this book achieves the goal successfully and does a nice job. I would highly recommend it ...The example-based approach is easy to follow and makes the book a very helpful desktop reference for many biostatistics methods." —Journal of Statistical Software Clinical Trial Data Analysis Using R and SAS, Second Edition provides a thorough presentation of biostatistical analyses of clinical trial data with step-by-step implementations using R and SAS. The book’s practical, detailed approach draws on the authors’ 30 years’ experience in biostatistical research and clinical development. The authors develop step-by-step analysis code using appropriate R packages and functions and SAS PROCS, which enables readers to gain an understanding of the analysis methods and R and SAS implementation so that they can use these two popular software packages to analyze their own clinical trial data. What’s New in the Second Edition Adds SAS programs along with the R programs for clinical trial data analysis. Updates all the statistical analysis with updated R packages. Includes correlated data analysis with multivariate analysis of variance. Applies R and SAS to clinical trial data from hypertension, duodenal ulcer, beta blockers, familial andenomatous polyposis, and breast cancer trials. Covers the biostatistical aspects of various clinical trials, including treatment comparisons, time-to-event endpoints, longitudinal clinical trials, and bioequivalence trials.