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Data Monitoring Committees In Clinical Trials

Author: Susan S. Ellenberg
Publisher: John Wiley & Sons
ISBN: 0470854154
Size: 63.31 MB
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There has been substantial growth in the use of data monitoring committees in recent years, by both government agencies and the pharmaceutical industry. This growth has been brought about by increasing recognition of the value of such committees in safeguarding trial participants as well as protecting trial integrity and the validity of conclusions. This very timely book describes the operation of data monitoring committees, and provides an authoritative guide to their establishment, purpose and responsibilities. * Provides a practical overview of data monitoring in clinical trials. * Describes the purpose, responsibilities and operation of data monitoring committees. * Provides directly applicable advice for those managing and conducting clinical trials, and those serving on data monitoring committees. * Gives insight into clinical data monitoring to those sitting on regulatory and ethical committees. * Discusses issues pertinent to those working in clinical trials in both the US and Europe. The practical guidance provided by this book will be of use to professionals working in and/or managing clinical trials, in academic, government and industry settings, particularly medical statisticians, clinicians, trial co-ordinators, and those working in regulatory affairs and bioethics.

Clinical And Translational Science

Author: David Robertson
Publisher: Academic Press
ISBN: 9780080920191
Size: 30.13 MB
Format: PDF
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Clinical or translational science is the field of study devoted to investigating human health and disease, interventions and outcomes for the purposes of developing new treatment approaches, devices, and modalities to improve health. New molecular tools and diagnostic technologies based on clinical and translational research have lead to a better understanding of human disease and the application of new therapeutics for enhanced health. Clinical and Translational Science is designed as the most authoritative and modern resource for the broad range of investigators in various medical specialties taking on the challenge of clinical research. Prepared with an international perspective, this resource begins with experimental design and investigative tools to set the scene for readers. It then moves on to human genetics and pharmacology with a focus on statistics, epidemiology, genomic information, drug discovery and development, and clinical trials. Finally, it turns to legal, social, and ethical issues of clinical research concluding with a discussion of future prospects to provide readers with a comprehensive view of the this developing area of science. Clinical research is one of the fastest growing fields in private practice and academic medicine with practical biological, physiological, cellular, and therapeutic applications Contributions from international leaders provide insight into background and future understanding for clinical and translational science Provides the structure for complete instruction and guidance on the subject from fundamental principles, approaches and infrastructure to human genetics, human pharmacology, research in special populations, the societal context of human research, and the future of human research

Statistical Practice In Business And Industry

Author: Shirley Coleman
Publisher: John Wiley & Sons
ISBN: 0470997478
Size: 34.39 MB
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This book covers all the latest advances, as well as more established methods, in the application of statistical and optimisation methods within modern industry. These include applications from a range of industries that include micro-electronics, chemical, automotive, engineering, food, component assembly, household goods and plastics. Methods range from basic graphical approaches to generalised modelling, from designed experiments to process control. Solutions cover produce and process design, through manufacture to packaging and delivery, from single responses to multivariate problems.

Multiple Imputation And Its Application

Author: James Carpenter
Publisher: John Wiley & Sons
ISBN: 1119942276
Size: 37.26 MB
Format: PDF
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A practical guide to analysing partially observeddata. Collecting, analysing and drawing inferences from data iscentral to research in the medical and social sciences.Unfortunately, it is rarely possible to collect all the intendeddata. The literature on inference from the resultingincomplete data is now huge, and continues to grow both asmethods are developed for large and complex data structures, and asincreasing computer power and suitable software enable researchersto apply these methods. This book focuses on a particular statistical method foranalysing and drawing inferences from incomplete data, calledMultiple Imputation (MI). MI is attractive because it is bothpractical and widely applicable. The authors aim is to clarify theissues raised by missing data, describing the rationale for MI, therelationship between the various imputation models and associatedalgorithms and its application to increasingly complex datastructures. Multiple Imputation and its Application: Discusses the issues raised by the analysis of partiallyobserved data, and the assumptions on which analyses rest. Presents a practical guide to the issues to consider whenanalysing incomplete data from both observational studies andrandomized trials. Provides a detailed discussion of the practical use of MI withreal-world examples drawn from medical and social statistics. Explores handling non-linear relationships and interactionswith multiple imputation, survival analysis, multilevel multipleimputation, sensitivity analysis via multiple imputation, usingnon-response weights with multiple imputation and doubly robustmultiple imputation. Multiple Imputation and its Application is aimed atquantitative researchers and students in the medical and socialsciences with the aim of clarifying the issues raised by theanalysis of incomplete data data, outlining the rationale for MIand describing how to consider and address the issues that arise inits application.

Comparing Clinical Measurement Methods

Author: Bendix Carstensen
Publisher: John Wiley & Sons
ISBN: 1119957540
Size: 32.51 MB
Format: PDF, ePub, Docs
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This book provides a practical guide to analysis of simple and complex method comparison data, using Stata, SAS and R. It takes the classical Limits of Agreement as a starting point, and presents it in a proper statistical framework. The model serves as a reference for reporting sources of variation and for providing conversion equations and plots between methods for practical use, including prediction uncertainty. Presents a modeling framework for analysis of data and reporting of results from comparing measurements from different clinical centers and/or different methods. Provides the practical tools for analyzing method comparison studies along with guidance on what to report and how to plan comparison studies and advice on appropriate software. Illustrated throughout with computer examples in R. Supported by a supplementary website hosting an R-package that performs the major part of the analyses needed in the area. Examples in SAS and Stata for the most common situations are also provided. Written by an acknowledged expert on the subject, with a long standing experience as a biostatistician in a clinical environment and a track record of delivering training on the subject. Biostatisticians, clinicians, medical researchers and practitioners involved in research and analysis of measurement methods and laboratory investigations will benefit from this book. Students of statistics, biostatistics, and the chemical sciences will also find this book useful.

Modeling Online Auctions

Author: Wolfgang Jank
Publisher: John Wiley & Sons
ISBN: 9781118031865
Size: 52.94 MB
Format: PDF, ePub
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Explore cutting-edge statistical methodologies for collecting, analyzing, and modeling online auction data Online auctions are an increasingly important marketplace, as the new mechanisms and formats underlying these auctions have enabled the capturing and recording of large amounts of bidding data that are used to make important business decisions. As a result, new statistical ideas and innovation are needed to understand bidders, sellers, and prices. Combining methodologies from the fields of statistics, data mining, information systems, and economics, Modeling Online Auctions introduces a new approach to identifying obstacles and asking new questions using online auction data. The authors draw upon their extensive experience to introduce the latest methods for extracting new knowledge from online auction data. Rather than approach the topic from the traditional game-theoretic perspective, the book treats the online auction mechanism as a data generator, outlining methods to collect, explore, model, and forecast data. Topics covered include: Data collection methods for online auctions and related issues that arise in drawing data samples from a Web site Models for bidder and bid arrivals, treating the different approaches for exploring bidder-seller networks Data exploration, such as integration of time series and cross-sectional information; curve clustering; semi-continuous data structures; and data hierarchies The use of functional regression as well as functional differential equation models, spatial models, and stochastic models for capturing relationships in auction data Specialized methods and models for forecasting auction prices and their applications in automated bidding decision rule systems Throughout the book, R and MATLAB software are used for illustrating the discussed techniques. In addition, a related Web site features many of the book's datasets and R and MATLAB code that allow readers to replicate the analyses and learn new methods to apply to their own research. Modeling Online Auctions is a valuable book for graduate-level courses on data mining and applied regression analysis. It is also a one-of-a-kind reference for researchers in the fields of statistics, information systems, business, and marketing who work with electronic data and are looking for new approaches for understanding online auctions and processes. Visit this book's companion website by clicking here

Principles And Practice Of Clinical Research

Author: John I. Gallin
Publisher: Academic Press
ISBN: 0128499044
Size: 17.33 MB
Format: PDF, Mobi
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Principles and Practice of Clinical Research, Fourth Edition has been thoroughly revised to provide a comprehensive look at both the fundamental principles and expanding practice of clinical research. New to this edition of this highly regarded reference, authors have focused on examples that broadly reflect clinical research on a global scale while including a discussion of international regulations, studies, and implications. In addition to key topics such as bioethics, clinical outcome data, cultural diversity, protocol guidelines, and “omic platforms, this edition contains new chapters devoted to electronic health records and information resources for clinical researchers, as well as the many opportunities associated with big data. Covering a vast number of topics and practical advice for both novice and advanced clinical investigators, this book is a highly relevant and essential resource for all those involved in conducting research. Features input from experts in the field dedicated to translating scientific research from bench to bedside and back Provides expanded coverage of global clinical research Contains hands-on, practical suggestions, illustrations, and examples throughout Includes new chapters on the international regulation of drugs and biologics, the emergence of the important role of comparative effectiveness research and how to identify clinical risks and manage patient safety in a clinical research setting

Applied Mixed Models In Medicine

Author: Helen Brown
Publisher: John Wiley & Sons
ISBN: 1118778243
Size: 51.10 MB
Format: PDF, Docs
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A fully updated edition of this key text on mixed models,focusing on applications in medical research The application of mixed models is an increasingly popular wayof analysing medical data, particularly in the pharmaceuticalindustry. A mixed model allows the incorporation of both fixed andrandom variables within a statistical analysis, enabling efficientinferences and more information to be gained from the data. Therehave been many recent advances in mixed modelling, particularlyregarding the software and applications. This third edition ofBrown and Prescott’s groundbreaking text provides an updateon the latest developments, and includes guidance on the use ofcurrent SAS techniques across a wide range of applications. Presents an overview of the theory and applications of mixedmodels in medical research, including the latest developments andnew sections on incomplete block designs and the analysis ofbilateral data. Easily accessible to practitioners in any area where mixedmodels are used, including medical statisticians andeconomists. Includes numerous examples using real data from medical andhealth research, and epidemiology, illustrated with SAS code andoutput. Features the new version of SAS, including new graphics formodel diagnostics and the procedure PROC MCMC. Supported by a website featuring computer code, data sets, andfurther material. This third edition will appeal to applied statisticians workingin medical research and the pharmaceutical industry, as well asteachers and students of statistics courses in mixed models. Thebook will also be of great value to a broad range of scientists,particularly those working in the medical and pharmaceuticalareas.

Tuberculosis E Book

Author: H. Simon Schaaf
Publisher: Elsevier Health Sciences
ISBN: 1437711065
Size: 23.34 MB
Format: PDF, ePub, Docs
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This book provides all the vital information you need to know about tuberculosis, especially in the face of drug-resistant strains of the disease. Coverage includes which patient populations face an elevated risk of infection, as well as which therapies are appropriate and how to correctly monitor ongoing treatment so that patients are cured. Properly administer screening tests, interpret their results, and identify manifestations of the disease, with authoritative guidance from expert clinicians from around the world. Discusses screening tests for tuberculosis so you can interpret their results and identify not only common manifestations of the disease, but also those that are comparatively rare—such as tuberculosis in pregnant women. Covers all clinical aspects of tuberculosis in children, including current practices on managing those infected with HIV. Provides details on how best to interact with the public health system in both industrialized and developing countries. Addresses the social aspects of tuberculosis and presents the latest advances on new and potential vaccines against tuberculosis. Offers the expertise of internationally recognized tuberculosis clinicians to provide you with well-rounded, global coverage. Features numerous illustrations to provide clear and detailed depictions of rare manifestations of tuberculosis.

Electrophysiological Disorders Of The Heart E Book

Author: Sanjeev Saksena
Publisher: Elsevier Health Sciences
ISBN: 1437709710
Size: 70.95 MB
Format: PDF, Kindle
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The new edition of Electrophysiological Disorders of the Heart helps you diagnose and treat a full range of heart rhythm disorders using today’s latest technologies and therapies. It provides practical, hands-on coverage of hot topics such as pediatric EP, imaging, echocardiography-guided EP procedures, regenerative therapies, cardiac pacing, and more. Now available in a new full-color format, the title also includes easy online access at www.expertconsult.com. Discover new ways to treat and manage the full range of heart rhythm disorders with content focused on common clinical features, diagnosis, and management. Review expert management strategies to help you handle complex patient problems. Stay current with the latest molecular and technical advances as well as new treatment options implemented over the last few years. Use the latest technologies and devices to accurately diagnose and manage heart rhythm disorders. Consult new and expanded coverage of regenerative therapies, echo-guided procedures, cardiac pacing, and CRT, as well as a new section on pediatric electrophysiology and imaging. Enjoy improved visual guidance with many new full-color images. Log on to www.expertconsult.com to easily search the complete contents online and access a downloadable image library.