An Introduction to Optimal Designs for Social and Biomedical Research

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Publisher : John Wiley & Sons
ISBN 13 : 9780470746929
Total Pages : 346 pages
Book Rating : 4.7/5 (469 download)

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Book Synopsis An Introduction to Optimal Designs for Social and Biomedical Research by : Martijn P.F. Berger

Download or read book An Introduction to Optimal Designs for Social and Biomedical Research written by Martijn P.F. Berger and published by John Wiley & Sons. This book was released on 2009-05-27 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: The increasing cost of research means that scientists are in more urgent need of optimal design theory to increase the efficiency of parameter estimators and the statistical power of their tests. The objectives of a good design are to provide interpretable and accurate inference at minimal costs. Optimal design theory can help to identify a design with maximum power and maximum information for a statistical model and, at the same time, enable researchers to check on the model assumptions. This Book: Introduces optimal experimental design in an accessible format. Provides guidelines for practitioners to increase the efficiency of their designs, and demonstrates how optimal designs can reduce a study’s costs. Discusses the merits of optimal designs and compares them with commonly used designs. Takes the reader from simple linear regression models to advanced designs for multiple linear regression and nonlinear models in a systematic manner. Illustrates design techniques with practical examples from social and biomedical research to enhance the reader’s understanding. Researchers and students studying social, behavioural and biomedical sciences will find this book useful for understanding design issues and in putting optimal design ideas to practice.

Optimal Design for Nonlinear Response Models

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Publisher : CRC Press
ISBN 13 : 1439821518
Total Pages : 404 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Optimal Design for Nonlinear Response Models by : Valerii V. Fedorov

Download or read book Optimal Design for Nonlinear Response Models written by Valerii V. Fedorov and published by CRC Press. This book was released on 2013-07-15 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: Optimal Design for Nonlinear Response Models discusses the theory and applications of model-based experimental design with a strong emphasis on biopharmaceutical studies. The book draws on the authors’ many years of experience in academia and the pharmaceutical industry. While the focus is on nonlinear models, the book begins with an explanation of the key ideas, using linear models as examples. Applying the linearization in the parameter space, it then covers nonlinear models and locally optimal designs as well as minimax, optimal on average, and Bayesian designs. The authors also discuss adaptive designs, focusing on procedures with non-informative stopping. The common goals of experimental design—such as reducing costs, supporting efficient decision making, and gaining maximum information under various constraints—are often the same across diverse applied areas. Ethical and regulatory aspects play a much more prominent role in biological, medical, and pharmaceutical research. The authors address all of these issues through many examples in the book.

Handbook of Item Response Theory

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Publisher : CRC Press
ISBN 13 : 1351645455
Total Pages : 1584 pages
Book Rating : 4.3/5 (516 download)

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Book Synopsis Handbook of Item Response Theory by : Wim J. van der Linden

Download or read book Handbook of Item Response Theory written by Wim J. van der Linden and published by CRC Press. This book was released on 2018-02-19 with total page 1584 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drawing on the work of 75 internationally acclaimed experts in the field, Handbook of Item Response Theory, Three-Volume Set presents all major item response models, classical and modern statistical tools used in item response theory (IRT), and major areas of applications of IRT in educational and psychological testing, medical diagnosis of patient-reported outcomes, and marketing research. It also covers CRAN packages, WinBUGS, Bilog MG, Multilog, Parscale, IRTPRO, Mplus, GLLAMM, Latent Gold, and numerous other software tools. A full update of editor Wim J. van der Linden and Ronald K. Hambleton’s classic Handbook of Modern Item Response Theory, this handbook has been expanded from 28 chapters to 85 chapters in three volumes. The three volumes are thoroughly edited and cross-referenced, with uniform notation, format, and pedagogical principles across all chapters. Each chapter is self-contained and deals with the latest developments in IRT.

Handbook of Design and Analysis of Experiments

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Publisher : CRC Press
ISBN 13 : 146650434X
Total Pages : 946 pages
Book Rating : 4.4/5 (665 download)

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Book Synopsis Handbook of Design and Analysis of Experiments by : Angela Dean

Download or read book Handbook of Design and Analysis of Experiments written by Angela Dean and published by CRC Press. This book was released on 2015-06-26 with total page 946 pages. Available in PDF, EPUB and Kindle. Book excerpt: This carefully edited collection synthesizes the state of the art in the theory and applications of designed experiments and their analyses. It provides a detailed overview of the tools required for the optimal design of experiments and their analyses. The handbook covers many recent advances in the field, including designs for nonlinear models and algorithms applicable to a wide variety of design problems. It also explores the extensive use of experimental designs in marketing, the pharmaceutical industry, engineering and other areas.

The SAGE Handbook of Multilevel Modeling

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Publisher : SAGE
ISBN 13 : 1473971314
Total Pages : 954 pages
Book Rating : 4.4/5 (739 download)

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Book Synopsis The SAGE Handbook of Multilevel Modeling by : Marc A. Scott

Download or read book The SAGE Handbook of Multilevel Modeling written by Marc A. Scott and published by SAGE. This book was released on 2013-08-31 with total page 954 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this important new Handbook, the editors have gathered together a range of leading contributors to introduce the theory and practice of multilevel modeling. The Handbook establishes the connections in multilevel modeling, bringing together leading experts from around the world to provide a roadmap for applied researchers linking theory and practice, as well as a unique arsenal of state-of-the-art tools. It forges vital connections that cross traditional disciplinary divides and introduces best practice in the field. Part I establishes the framework for estimation and inference, including chapters dedicated to notation, model selection, fixed and random effects, and causal inference. Part II develops variations and extensions, such as nonlinear, semiparametric and latent class models. Part III includes discussion of missing data and robust methods, assessment of fit and software. Part IV consists of exemplary modeling and data analyses written by methodologists working in specific disciplines. Combining practical pieces with overviews of the field, this Handbook is essential reading for any student or researcher looking to apply multilevel techniques in their own research.

Introduction to Probability and Statistics for Ecosystem Managers

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Publisher : John Wiley & Sons
ISBN 13 : 1118636236
Total Pages : 271 pages
Book Rating : 4.1/5 (186 download)

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Book Synopsis Introduction to Probability and Statistics for Ecosystem Managers by : Timothy C. Haas

Download or read book Introduction to Probability and Statistics for Ecosystem Managers written by Timothy C. Haas and published by John Wiley & Sons. This book was released on 2013-05-21 with total page 271 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explores computer-intensive probability and statistics for ecosystem management decision making Simulation is an accessible way to explain probability and stochastic model behavior to beginners. This book introduces probability and statistics to future and practicing ecosystem managers by providing a comprehensive treatment of these two areas. The author presents a self-contained introduction for individuals involved in monitoring, assessing, and managing ecosystems and features intuitive, simulation-based explanations of probabilistic and statistical concepts. Mathematical programming details are provided for estimating ecosystem model parameters with Minimum Distance, a robust and computer-intensive method. The majority of examples illustrate how probability and statistics can be applied to ecosystem management challenges. There are over 50 exercises – making this book suitable for a lecture course in a natural resource and/or wildlife management department, or as the main text in a program of self-study. Key features: Reviews different approaches to wildlife and ecosystem management and inference. Uses simulation as an accessible way to explain probability and stochastic model behavior to beginners. Covers material from basic probability through to hierarchical Bayesian models and spatial/ spatio-temporal statistical inference. Provides detailed instructions for using R, along with complete R programs to recreate the output of the many examples presented. Provides an introduction to Geographic Information Systems (GIS) along with examples from Quantum GIS, a free GIS software package. A companion website featuring all R code and data used throughout the book. Solutions to all exercises are presented along with an online intelligent tutoring system that supports readers who are using the book for self-study.

How to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research

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Publisher : John Wiley & Sons
ISBN 13 : 1118763602
Total Pages : 266 pages
Book Rating : 4.1/5 (187 download)

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Book Synopsis How to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research by : Michael J. Campbell

Download or read book How to Design, Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research written by Michael J. Campbell and published by John Wiley & Sons. This book was released on 2014-03-28 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Crossover Designs

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Publisher : John Wiley & Sons
ISBN 13 : 1119114691
Total Pages : 248 pages
Book Rating : 4.1/5 (191 download)

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Book Synopsis Crossover Designs by : Kung-Jong Lui

Download or read book Crossover Designs written by Kung-Jong Lui and published by John Wiley & Sons. This book was released on 2016-08-08 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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: Provides exact test procedures and interval estimators, which are especially of use in small-sample cases. 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. Each chapter is self-contained, allowing the book to be used a reference resource. Uses real-life examples to illustrate the practical use of test procedures and estimators 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.

Spatio-temporal Design

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Publisher : John Wiley & Sons
ISBN 13 : 1118441885
Total Pages : 320 pages
Book Rating : 4.1/5 (184 download)

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Book Synopsis Spatio-temporal Design by : Jorge Mateu

Download or read book Spatio-temporal Design written by Jorge Mateu and published by John Wiley & Sons. This book was released on 2012-11-05 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: A state-of-the-art presentation of optimum spatio-temporal sampling design - bridging classic ideas with modern statistical modeling concepts and the latest computational methods. Spatio-temporal Design presents a comprehensive state-of-the-art presentation combining both classical and modern treatments of network design and planning for spatial and spatio-temporal data acquisition. A common problem set is interwoven throughout the chapters, providing various perspectives to illustrate a complete insight to the problem at hand. Motivated by the high demand for statistical analysis of data that takes spatial and spatio-temporal information into account, this book incorporates ideas from the areas of time series, spatial statistics and stochastic processes, and combines them to discuss optimum spatio-temporal sampling design. Spatio-temporal Design: Advances in Efficient Data Acquisition: Provides an up-to-date account of how to collect space-time data for monitoring, with a focus on statistical aspects and the latest computational methods Discusses basic methods and distinguishes between design and model-based approaches to collecting space-time data. Features model-based frequentist design for univariate and multivariate geostatistics, and second-phase spatial sampling. Integrates common data examples and case studies throughout the book in order to demonstrate the different approaches and their integration. Includes real data sets, data generating mechanisms and simulation scenarios. Accompanied by a supporting website featuring R code. Spatio-temporal Design presents an excellent book for graduate level students as well as a valuable reference for researchers and practitioners in the fields of applied mathematics, engineering, and the environmental and health sciences.

Platform Trial Designs in Drug Development

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Publisher : CRC Press
ISBN 13 : 1351683934
Total Pages : 323 pages
Book Rating : 4.3/5 (516 download)

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Book Synopsis Platform Trial Designs in Drug Development by : Zoran Antonijevic

Download or read book Platform Trial Designs in Drug Development written by Zoran Antonijevic and published by CRC Press. This book was released on 2018-12-07 with total page 323 pages. Available in PDF, EPUB and Kindle. Book excerpt: Platform trials test multiple therapies in one indication, one therapy for multiple indications, or both. These novel clinical trial designs can dramatically increase the cost-effectiveness of drug development, leading to life-altering medicines for people suffering from serious illnesses, possibly at lower cost. Currently, the cost of drug development is unsustainable. Furthermore, there are particular problems in rare diseases and small biomarker defined subsets in oncology, where the required sample sizes for traditional clinical trial designs may not be feasible. The editors recruited the key innovators in this domain. The 20 articles discuss trial designs from perspectives as diverse as quantum computing, patient’s rights to information, and international health. The book begins with an overview of platform trials from multiple perspectives. It then describes impacts of platform trials on the pharmaceutical industry’s key stakeholders: patients, regulators, and payers. Next it provides advanced statistical methods that address multiple aspects of platform trials, before concluding with a pharmaceutical executive’s perspective on platform trials. Except for the statistical methods section, only a basic qualitative knowledge of clinical trials is needed to appreciate the important concepts and novel ideas presented.

A Practical Guide to Designing Phase II Trials in Oncology

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Publisher : John Wiley & Sons
ISBN 13 : 1118570901
Total Pages : 260 pages
Book Rating : 4.1/5 (185 download)

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Book Synopsis A Practical Guide to Designing Phase II Trials in Oncology by : Sarah R. Brown

Download or read book A Practical Guide to Designing Phase II Trials in Oncology written by Sarah R. Brown and published by John Wiley & Sons. This book was released on 2014-05-12 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt: How to identify optimal phase II trial designs Providing a practical guide containing the information needed to make crucial decisions regarding phase II trial designs, A Practical Guide to Designing Phase II Trials in Oncology sets forth specific points for consideration between the statistician and clinician when designing a phase II trial, including issues such as how the treatment works, choice of outcome measure and randomization, and considering both academic and industry perspectives. A comprehensive and systematic library of available phase II trial designs is included, saving time otherwise spent considering multiple manuscripts, and real-life practical examples of using this approach to design phase II trials in cancer are given. A Practical Guide to Designing Phase II Trials in Oncology: Offers a structured and practical approach to phase II trial design Considers trial design from both an academic and industry perspective Includes a structured library of available phase II trial designs Is relevant to both clinical and statistical researchers at all levels Includes real life examples of applying this approach For those new to trial design, A Practical Guide to Designing Phase II Trials in Oncology will be a unique and practical learning tool, providing an introduction to the concepts behind informed decision making in phase II trials. For more experienced practitioners, the book will offer an overview of new, less familiar approaches to phase II trial design, providing alternative options to those which they may have previously used.

Randomised Response-Adaptive Designs in Clinical Trials

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Publisher : CRC Press
ISBN 13 : 1584886935
Total Pages : 341 pages
Book Rating : 4.5/5 (848 download)

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Book Synopsis Randomised Response-Adaptive Designs in Clinical Trials by : Anthony C Atkinson

Download or read book Randomised Response-Adaptive Designs in Clinical Trials written by Anthony C Atkinson and published by CRC Press. This book was released on 2013-12-26 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomised Response-Adaptive Designs in Clinical Trials presents methods for the randomised allocation of treatments to patients in sequential clinical trials. Emphasizing the practical application of clinical trial designs, the book is designed for medical and applied statisticians, clinicians, and statisticians in training. After introducing clinical trials in drug development, the authors assess a simple adaptive design for binary responses without covariates. They discuss randomisation and covariate balance in normally distributed responses and cover many important response-adaptive designs for binary responses. The book then develops response-adaptive designs for continuous and longitudinal responses, optimum designs with covariates, and response-adaptive designs with covariates. It also covers response-adaptive designs that are derived by optimising an objective function subject to constraints on the variance of estimated parametric functions. The concluding chapter explores future directions in the development of adaptive designs.

Statistical Methods for Evaluating Safety in Medical Product Development

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Publisher : John Wiley & Sons
ISBN 13 : 1118763106
Total Pages : 390 pages
Book Rating : 4.1/5 (187 download)

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Book Synopsis Statistical Methods for Evaluating Safety in Medical Product Development by : A. Lawrence Gould

Download or read book Statistical Methods for Evaluating Safety in Medical Product Development written by A. Lawrence Gould and published by John Wiley & Sons. This book was released on 2014-12-08 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book gives professionals in clinical research valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It also provides understanding and practical guidance on the application of contemporary statistical methods to contemporary issues in safety evaluation during medical product development. Each chapter provides sufficient detail to the reader to undertake the design and analysis of experiments at various stages of product development, including comprehensive references to the relevant literature. Provides a guide to statistical methods and application in medical product development Assists readers in undertaking design and analysis of experiments at various stages of product development Features case studies throughout the book, as well as, SAS and R code

Experimental Design for Laboratory Biologists

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Publisher : Cambridge University Press
ISBN 13 : 1316810674
Total Pages : 429 pages
Book Rating : 4.3/5 (168 download)

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Book Synopsis Experimental Design for Laboratory Biologists by : Stanley E. Lazic

Download or read book Experimental Design for Laboratory Biologists written by Stanley E. Lazic and published by Cambridge University Press. This book was released on 2016-12-08 with total page 429 pages. Available in PDF, EPUB and Kindle. Book excerpt: Specifically intended for lab-based biomedical researchers, this practical guide shows how to design experiments that are reproducible, with low bias, high precision, and widely applicable results. With specific examples from research using both cell cultures and model organisms, it explores key ideas in experimental design, assesses common designs, and shows how to plan a successful experiment. It demonstrates how to control biological and technical factors that can introduce bias or add noise, and covers rarely discussed topics such as graphical data exploration, choosing outcome variables, data quality control checks, and data pre-processing. It also shows how to use R for analysis, and is designed for those with no prior experience. An accompanying website (https://stanlazic.github.io/EDLB.html) includes all R code, data sets, and the labstats R package. This is an ideal guide for anyone conducting lab-based biological research, from students to principle investigators working in either academia or industry.

Binary Data Analysis of Randomized Clinical Trials with Noncompliance

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Publisher : John Wiley & Sons
ISBN 13 : 1119993903
Total Pages : 217 pages
Book Rating : 4.1/5 (199 download)

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Book Synopsis Binary Data Analysis of Randomized Clinical Trials with Noncompliance by : Kung-Jong Lui

Download or read book Binary Data Analysis of Randomized Clinical Trials with Noncompliance written by Kung-Jong Lui and published by John Wiley & Sons. This book was released on 2011-03-31 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is quite common in a randomized clinical trial (RCT) to encounter patients who do not comply with their assigned treatment. Since noncompliance often occurs non-randomly, the commonly-used approaches, including both the as-treated (AT) and as-protocol (AP) analysis, and the intent-to-treat (ITT) (or as-randomized) analysis, are all well known to possibly produce a biased inference of the treatment efficacy. This book provides a systematic and organized approach to analyzing data for RCTs with noncompliance under the most frequently-encountered situations. These include parallel sampling, stratified sampling, cluster sampling, parallel sampling with subsequent missing outcomes, and a series of dependent Bernoulli sampling for repeated measurements. The author provides a comprehensive approach by using contingency tables to illustrate the latent probability structure of observed data. Using real-life examples, computer-simulated data and exercises in each chapter, the book illustrates the underlying theory in an accessible, and easy to understand way. Key features: Consort-flow diagrams and numerical examples are used to illustrate the bias of commonly used approaches, such as, AT analysis, AP analysis and ITT analysis for a RCT with noncompliance. Real-life examples are used throughout the book to explain the practical usefulness of test procedures and estimators. Each chapter is self-contained, allowing the book to be used as a reference source. Includes SAS programs which can be easily modified in calculating the required sample size. Biostatisticians, clinicians, researchers and data analysts working in pharmaceutical industries will benefit from this book. This text can also be used as supplemental material for a course focusing on clinical statistics or experimental trials in epidemiology, psychology and sociology.

Bayesian Networks for Probabilistic Inference and Decision Analysis in Forensic Science

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Publisher : John Wiley & Sons
ISBN 13 : 1118914740
Total Pages : 472 pages
Book Rating : 4.1/5 (189 download)

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Book Synopsis Bayesian Networks for Probabilistic Inference and Decision Analysis in Forensic Science by : Franco Taroni

Download or read book Bayesian Networks for Probabilistic Inference and Decision Analysis in Forensic Science written by Franco Taroni and published by John Wiley & Sons. This book was released on 2014-07-21 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bayesian Networks “This book should have a place on the bookshelf of every forensic scientist who cares about the science of evidence interpretation.” Dr. Ian Evett, Principal Forensic Services Ltd, London, UK Bayesian Networks for Probabilistic Inference and Decision Analysis in Forensic Science Second Edition Continuing developments in science and technology mean that the amounts of information forensic scientists are able to provide for criminal investigations is ever increasing. The commensurate increase in complexity creates diffculties for scientists and lawyers with regard to evaluation and interpretation, notably with respect to issues of inference and decision. Probability theory, implemented through graphical methods, and specifically Bayesian networks, provides powerful methods to deal with this complexity. Extensions of these methods to elements of decision theory provide further support and assistance to the judicial system. Bayesian Networks for Probabilistic Inference and Decision Analysis in Forensic Science provides a unique and comprehensive introduction to the use of Bayesian decision networks for the evaluation and interpretation of scientific findings in forensic science, and for the support of decision-makers in their scientific and legal tasks. Includes self-contained introductions to probability and decision theory. Develops the characteristics of Bayesian networks, object-oriented Bayesian networks and their extension to decision models. Features implementation of the methodology with reference to commercial and academically available software. Presents standard networks and their extensions that can be easily implemented and that can assist in the reader’s own analysis of real cases. Provides a technique for structuring problems and organizing data based on methods and principles of scientific reasoning. Contains a method for the construction of coherent and defensible arguments for the analysis and evaluation of scientific findings and for decisions based on them. Is written in a lucid style, suitable for forensic scientists and lawyers with minimal mathematical background. Includes a foreword by Ian Evett. The clear and accessible style of this second edition makes this book ideal for all forensic scientists, applied statisticians and graduate students wishing to evaluate forensic findings from the perspective of probability and decision analysis. It will also appeal to lawyers and other scientists and professionals interested in the evaluation and interpretation of forensic findings, including decision making based on scientific information.

Data Monitoring Committees in Clinical Trials

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Publisher : John Wiley & Sons
ISBN 13 : 1119512670
Total Pages : 268 pages
Book Rating : 4.1/5 (195 download)

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Book Synopsis Data Monitoring Committees in Clinical Trials by : Susan S. Ellenberg

Download or read book Data Monitoring Committees in Clinical Trials written by Susan S. Ellenberg and published by John Wiley & Sons. This book was released on 2019-01-15 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: The authoritative guide for Data Monitoring Committees—fully revised and updated The number of clinical trials sponsored by government agencies and pharmaceutical companies has grown in recent years, prompting an increased need for interim monitoring of data on safety and efficacy. Data Monitoring Committees (DMCs) are an essential component of many clinical trials, safeguarding trial participants and protecting the credibility and validity of the study. Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition offers practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees, providing a practical overview of the establishment, purpose, and responsibilities of these committees. Examination of topics such as the composition and independence of DMCs, statistical, philosophical and ethical considerations, and determining when a DMC is needed, presents readers with a comprehensive foundational knowledge of clinical trial oversight. Providing recent examples to illustrate DMC principles, this fully-updated guide reflects current developments and practices in clinical trial oversight and offers expanded coverage of emerging issues and challenges in the field. This new second edition covers the most current information on DMC policies, issues in monitoring trials using new designs, and recent trial publications relevant to DMC decision-making. • Presents practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees • Illustrates the types of challenging issues Data Monitoring Committees face in practical situations • Provides updated and expanded coverage of topics including regulatory and funding agency guidelines and trial designs and their associated demands and limitations • Includes a new chapter addressing legal issues that affect DMC members and discusses general litigation concerns relevant to clinical research • Expands treatment of current journal publications addressing DMC issues Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition is a must-have text for anyone engaged in DMC activities as well as trial sponsors, clinical trial researchers, regulatory and bioethics professionals, and those associated with clinical trials in academic, government and industry settings.