Download or read book Human Experimentation written by Ton J. Cleophas and published by Springer Science & Business Media. This book was released on 1999-07-31 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite their effectiveness in the evaluation of new pharmacological compounds, controlled clinical trials are sometimes inadequate. Using data from the literature as well as from the author's own experience with clinical trials, Human Experimentation: Methodologic Issues Fundamental to Clinical Trials addresses such inadequacies and tries to provide solutions. This work is the first to thoroughly examine these unsolved inadequacies and problems with the design and the execution of clinical trials and, more importantly, to provide solutions for these problems. It is important for anyone who is involved in clinical research: clinicians, pharmacists, biochemists, statisticians, nurses, sponsors, etc., and anyone who is involved in applying results of research to patients, i.e. physicians.
Download or read book Design and Analysis of Cross Over Trials Second Edition written by Byron Jones and published by CRC Press. This book was released on 2003-03-12 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first edition of Design and Analysis of Cross-Over Trials quickly became the standard reference on the subject and has remained so for more than 12 years. In that time, however, the use of cross-over trials has grown rapidly, particularly in the pharmaceutical arena, and researchers have made a number of advances in both the theory and methods applicable to these trials. Completely revised and updated, the long-awaited second edition of this classic text retains its predecessor's careful balance of theory and practice while incorporating new approaches, more data sets, and a broader scope. Enhancements in the second edition include: A new chapter on bioequivalence Recently developed methods for analyzing longitudinal continuous and categorical data Real-world examples using the SAS system A comprehensive catalog of designs, datasets, and SAS programs available on a companion Web site at www.crcpress.com The authors' exposition gives a clear, unified account of the design and analysis of cross-over trials from a statistical perspective along with their methodological underpinnings. With SAS programs and a thorough treatment of design issues, Design and Analysis of Cross-Over Trials, Second Edition sets a new standard for texts in this area and undoubtedly will be of direct practical value for years to come.
Download or read book Optimal Crossover Designs written by Mausumi Bose and published by World Scientific. This book was released on 2009 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt: This monograph presents a comprehensive and up-to-date account of the developments in optimality aspects of crossover designs. Crossover designs are immensely useful in various areas of human investigation including agriculture, animal nutrition, clinical trials, pharmaceutical studies, biological assays, weather modification experiments, sensory evaluation of food products and learning experiments. Research on the optimality aspects of crossover designs has developed only in the last three decades, and it has now emerged as a potential field for further investigation. This book is the first comprehensive treatise on this subject. It covers optimal crossover designs at length by consolidating vast amounts of material from the literature, and includes many recent and deep results. It is expected that this book will not only provide a one-stop reference for the available results, but also encourage further research in this area of substantial practical relevance.
Download or read book Design and Analysis of Cross Over Trials Second Edition written by Byron Jones and published by CRC Press. This book was released on 2003-03-12 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first edition of Design and Analysis of Cross-Over Trials quickly became the standard reference on the subject and has remained so for more than 12 years. In that time, however, the use of cross-over trials has grown rapidly, particularly in the pharmaceutical arena, and researchers have made a number of advances in both the theory and methods applicable to these trials. Completely revised and updated, the long-awaited second edition of this classic text retains its predecessor's careful balance of theory and practice while incorporating new approaches, more data sets, and a broader scope. Enhancements in the second edition include: A new chapter on bioequivalence Recently developed methods for analyzing longitudinal continuous and categorical data Real-world examples using the SAS system A comprehensive catalog of designs, datasets, and SAS programs available on a companion Web site at www.crcpress.com The authors' exposition gives a clear, unified account of the design and analysis of cross-over trials from a statistical perspective along with their methodological underpinnings. With SAS programs and a thorough treatment of design issues, Design and Analysis of Cross-Over Trials, Second Edition sets a new standard for texts in this area and undoubtedly will be of direct practical value for years to come.
Download or read book Design and Analysis of Cross Over Trials written by Byron Jones and published by Chapman and Hall/CRC. This book was released on 1989-06 with total page 358 pages. Available in PDF, EPUB and Kindle. Book excerpt: Representing the current state of the art in cross-over trials, this text aims to act as a basic reference text for future research as well as a source of practical and useful advice for statisticians and clinicians involved in the planning and analysis of cross-over trials.
Download or read book Cross over Trials in Clinical Research written by Stephen S. Senn and published by John Wiley & Sons. This book was released on 2003-07-25 with total page 364 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Cross Over Experiments written by David Ratkowsky and published by CRC Press. This book was released on 2020-01-29 with total page 468 pages. Available in PDF, EPUB and Kindle. Book excerpt: Developing a model-based approach that enables any cross-over trial, of any degree of imbalance, to be analyzed both for direct effects and for residual effects, using consistent procedures that employ commercially available statistical software, this text offers a guide to the analysis of cross-over designs.;Illustrating practical applications throughout with examples, this book: emphasizes the importance of choosing highly efficient designs that separate treatment and carryover effects; demonstrates the exact methodology needed to handle the analysis of data; presents a new methodology for the analysis of binary and categorical data; and considers the effects of blocking. The appendices facilitate the choosing of an appropriate design for every experimental need.
Download or read book Design and Analysis of Cross Over Trials Third Edition written by Byron Jones and published by CRC Press. This book was released on 2014-10-08 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Proceedings of the Biometrics Section written by American Statistical Association. Biometrics Section and published by . This book was released on 1996 with total page 462 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Analysis of Repeated Measures written by Martin J. Crowder and published by Routledge. This book was released on 2017-10-24 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: Repeated measures data arise when the same characteristic is measured on each case or subject at several times or under several conditions. There is a multitude of techniques available for analysing such data and in the past this has led to some confusion. This book describes the whole spectrum of approaches, beginning with very simple and crude methods, working through intermediate techniques commonly used by consultant statisticians, and concluding with more recent and advanced methods. Those covered include multiple testing, response feature analysis, univariate analysis of variance approaches, multivariate analysis of variance approaches, regression models, two-stage line models, approaches to categorical data and techniques for analysing crossover designs. The theory is illustrated with examples, using real data brought to the authors during their work as statistical consultants.
Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Statistical Methodology in the Pharmaceutical Sciences written by D. A. Berry and published by CRC Press. This book was released on 2016-04-19 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: A state-of-the-art handbook of statistical analysis for use in the pharmaceutical industry. Areas covered in this reference/text include: bioavailability, repeated-measures designs, dose-response, population models, multicenter trials, handling dropouts, survival analysis, robust data analysis, cate
Download or read book The Analysis of Incomplete Data in the Three period Two treatment Crossover Design for Clinical Trials written by Barbra Ann Richardson and published by . This book was released on 1993 with total page 470 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Biostatistics in Clinical Trials written by Carol K. Redmond and published by John Wiley & Sons. This book was released on 2001-04-25 with total page 530 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second volume in the Wiley reference series in Biostatistics. Featuring articles from the prestigious Encyclopedia of Biostatistics, many of which have been fully revised and updated to include recent developments, Biostatistics in Clinical Trials also includes up to 25% newly commissioned material reflecting the latest thinking in: Bayesian methods Benefit/risk assessment Cost-effectiveness Ethics Fraud With exceptional contributions from leading experts in academia, government and industry, Biostatistics in Clinical Trials has been designed to complement existing texts by providing extensive, up-to-date coverage and introducing the reader to the research literature. Offering comprehensive coverage of all aspects of clinical trials Biostatistics in Clinical Trials: Includes concise definitions and introductions to numerous concepts found in current literature Discusses the software and textbooks available Uses extensive cross-references helping to facilitate further research and enabling the reader to locate definitions and related concepts Biostatistics in Clinical Trials offers both academics and practitioners from various disciplines and settings, such as universities, the pharmaceutical industry and clinical research organisations, up-to-date information as well as references to assist professionals involved in the design and conduct of clinical trials.
Download or read book Encyclopedia of Biopharmaceutical Statistics Four Volume Set written by Shein-Chung Chow and published by CRC Press. This book was released on 2018-09-03 with total page 2434 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.
Download or read book Encyclopaedic Companion to Medical Statistics written by Brian S. Everitt and published by John Wiley & Sons. This book was released on 2011-06-20 with total page 753 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical methodology is of great importance to medical research and clinical practice. The Encyclopaedic Companion to Medical Statistics contains readable accounts of the key topics central to current research and practice. Each entry has been written by an individual chosen for both their expertise in the field and their ability to communicate statistical concepts successfully to medical researchers. Real examples from the biomedical literature and relevant illustrations feature in many entries and extensive cross–referencing signposts the reader to related entries. Key Features: Contains accounts of over 400 statistical topics central to current medical research. 80% of first edition entries updated and revised. Presents the latest techniques used at the cutting edge of medical research. Covers common errors in statistical analyses in medicine. Real examples from the biomedical literature and relevant illustrations feature throughout. Contains contributions from over 70 experts in the field. Medical researchers, researchers and practitioners in medical research and statistics will benefit greatly from this book.
Download or read book Human Experimentation written by Ton J. Cleophas and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite their effectiveness in the evaluation of new pharmacological compounds, controlled clinical trials are sometimes inadequate. Using data from the literature as well as from the author's own experience with clinical trials, Human Experimentation: Methodologic Issues Fundamental to Clinical Trials addresses such inadequacies and tries to provide solutions. This work is the first to thoroughly examine these unsolved inadequacies and problems with the design and the execution of clinical trials and, more importantly, to provide solutions for these problems. It is important for anyone who is involved in clinical research: clinicians, pharmacists, biochemists, statisticians, nurses, sponsors, etc., and anyone who is involved in applying results of research to patients, i.e. physicians.
