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Data Monitoring Committees In Clinical Trials

Author: Susan S. Ellenberg
Publisher: John Wiley & Sons
ISBN: 0470854154
Size: 38.57 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: 69.78 MB
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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

Data And Safety Monitoring Committees In Clinical Trials Second Edition

Author: Jay Herson
Publisher: CRC Press
ISBN: 1498784127
Size: 63.24 MB
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Praise for the first edition: "Given the author’s years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book—not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC." -S. T. Ounpraseuth, The American Statistician ? In the first edition of this well-regarded book, the author provided a groundbreaking and definitive guide to best practices in pharmaceutical industry data monitoring committees (DMCs). Maintaining all the material from the first edition and adding substantial new material, Data and Safety Monitoring Committees in Clinical Trials, Second Edition is ideal for training professionals to serve on their first DMC as well as for experienced clinical and biostatistical DMC members, sponsor and regulatory agency staff. The second edition guides the reader through newly emerging DMC responsibilities brought about by regulations emphasizing risk vs benefit and the emergence of risk-based monitoring. It also provides the reader with many new statistical methods, clinical trial designs and clinical terminology that have emerged since the first edition. The references have been updated and the very popular end-of-chapter Q&A section has been supplemented with many new experiences since the first edition. ? New to the Second Edition: Presents statistical methods, tables, listings and graphs appropriate for safety review, efficacy analysis and risk vs benefit analysis, SPERT and PRISMA initiatives. Newly added interim analysis for efficacy and futility section. DMC responsibilities in SUSARs (Serious Unexpected Serious Adverse Reactions), basket trials, umbrella trials, dynamic treatment strategies /SMART trials, pragmatic trials, biosimilar trials, companion diagnostics, etc. DMC responsibilities for data quality and fraud detection (Fraud Recovery Plan) Use of patient reported outcomes of safety Use of meta analysis and data outside the trial New ideas for training and compensation of DMC members ? Jay Herson is Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years experience in clinical trials in academia and the pharmaceutical industry. ? ? ? ? ? ? ? ? ? ? ? ? ?

Statistical Practice In Business And Industry

Author: Shirley Coleman
Publisher: John Wiley & Sons
ISBN: 0470997478
Size: 10.37 MB
Format: PDF, ePub, Mobi
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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.

Advances In Statistical Monitoring Of Complex Multivariate Processes

Author: Uwe Kruger
Publisher: John Wiley & Sons
ISBN: 1118381262
Size: 55.29 MB
Format: PDF, ePub, Docs
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The development and application of multivariate statistical techniques in process monitoring has gained substantial interest over the past two decades in academia and industry alike. Initially developed for monitoring and fault diagnosis in complex systems, such techniques have been refined and applied in various engineering areas, for example mechanical and manufacturing, chemical, electrical and electronic, and power engineering. The recipe for the tremendous interest in multivariate statistical techniques lies in its simplicity and adaptability for developing monitoring applications. In contrast, competitive model, signal or knowledge based techniques showed their potential only whenever cost-benefit economics have justified the required effort in developing applications. Statistical Monitoring of Complex Multivariate Processes presents recent advances in statistics based process monitoring, explaining how these processes can now be used in areas such as mechanical and manufacturing engineering for example, in addition to the traditional chemical industry. This book: Contains a detailed theoretical background of the component technology. Brings together a large body of work to address the field’s drawbacks, and develops methods for their improvement. Details cross-disciplinary utilization, exemplified by examples in chemical, mechanical and manufacturing engineering. Presents real life industrial applications, outlining deficiencies in the methodology and how to address them. Includes numerous examples, tutorial questions and homework assignments in the form of individual and team-based projects, to enhance the learning experience. Features a supplementary website including Matlab algorithms and data sets. This book provides a timely reference text to the rapidly evolving area of multivariate statistical analysis for academics, advanced level students, and practitioners alike.

Multiple Imputation And Its Application

Author: James Carpenter
Publisher: John Wiley & Sons
ISBN: 1119942276
Size: 52.68 MB
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A practical guide to analysing partially observed data. Collecting, analysing and drawing inferences from data is central to research in the medical and social sciences. Unfortunately, it is rarely possible to collect all the intended data. The literature on inference from the resulting incomplete data is now huge, and continues to grow both as methods are developed for large and complex data structures, and as increasing computer power and suitable software enable researchers to apply these methods. This book focuses on a particular statistical method for analysing and drawing inferences from incomplete data, called Multiple Imputation (MI). MI is attractive because it is both practical and widely applicable. The authors aim is to clarify the issues raised by missing data, describing the rationale for MI, the relationship between the various imputation models and associated algorithms and its application to increasingly complex data structures. Multiple Imputation and its Application: Discusses the issues raised by the analysis of partially observed data, and the assumptions on which analyses rest. Presents a practical guide to the issues to consider when analysing incomplete data from both observational studies and randomized trials. Provides a detailed discussion of the practical use of MI with real-world examples drawn from medical and social statistics. Explores handling non-linear relationships and interactions with multiple imputation, survival analysis, multilevel multiple imputation, sensitivity analysis via multiple imputation, using non-response weights with multiple imputation and doubly robust multiple imputation. Multiple Imputation and its Application is aimed at quantitative researchers and students in the medical and social sciences with the aim of clarifying the issues raised by the analysis of incomplete data data, outlining the rationale for MI and describing how to consider and address the issues that arise in its application.

Statistical Methods For Hospital Monitoring With R

Author: Anthony Morton
Publisher: John Wiley & Sons
ISBN: 1118639170
Size: 36.80 MB
Format: PDF
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Hospitals monitoring is becoming more complex and is increasing both because staff want their data analysed and because of increasing mandated surveillance. This book provides a suite of functions in R, enabling scientists and data analysts working in infection management and quality improvement departments in hospitals, to analyse their often non-independent data which is frequently in the form of trended, over-dispersed and sometimes auto-correlated time series; this is often difficult to analyse using standard office software. This book provides much-needed guidance on data analysis using R for the growing number of scientists in hospital departments who are responsible for producing reports, and who may have limited statistical expertise. This book explores data analysis using R and is aimed at scientists in hospital departments who are responsible for producing reports, and who are involved in improving safety. Professionals working in the healthcare quality and safety community will also find this book of interest Statistical Methods for Hospital Monitoring with R: Provides functions to perform quality improvement and infection management data analysis. Explores the characteristics of complex systems, such as self-organisation and emergent behaviour, along with their implications for such activities as root-cause analysis and the Pareto principle that seek few key causes of adverse events. Provides a summary of key non-statistical aspects of hospital safety and easy to use functions. Provides R scripts in an accompanying web site enabling analyses to be performed by the reader http://www.wiley.com/go/hospital_monitoring Covers issues that will be of increasing importance in the future, such as, generalised additive models, and complex systems, networks and power laws.

Modeling Online Auctions

Author: Wolfgang Jank
Publisher: John Wiley & Sons
ISBN: 9781118031865
Size: 17.50 MB
Format: PDF
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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

Applied Mixed Models In Medicine

Author: Helen Brown
Publisher: John Wiley & Sons
ISBN: 1118778243
Size: 18.16 MB
Format: PDF
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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 way of analysing medical data, particularly in the pharmaceutical industry. A mixed model allows the incorporation of both fixed and random variables within a statistical analysis, enabling efficient inferences and more information to be gained from the data. There have been many recent advances in mixed modelling, particularly regarding the software and applications. This third edition of Brown and Prescott’s groundbreaking text provides an update on the latest developments, and includes guidance on the use of current SAS techniques across a wide range of applications. Presents an overview of the theory and applications of mixed models in medical research, including the latest developments and new sections on incomplete block designs and the analysis of bilateral data. Easily accessible to practitioners in any area where mixed models are used, including medical statisticians and economists. Includes numerous examples using real data from medical and health research, and epidemiology, illustrated with SAS code and output. Features the new version of SAS, including new graphics for model diagnostics and the procedure PROC MCMC. Supported by a website featuring computer code, data sets, and further material. This third edition will appeal to applied statisticians working in medical research and the pharmaceutical industry, as well as teachers and students of statistics courses in mixed models. The book will also be of great value to a broad range of scientists, particularly those working in the medical and pharmaceutical areas.

Principles And Practice Of Clinical Research

Author: John I. Gallin
Publisher: Academic Press
ISBN: 0128499044
Size: 36.73 MB
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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