crossover designs testing estimation and sample size statistics in practice

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Crossover Designs

Author : Kung-Jong Lui
ISBN : 9781119114680
Genre : Mathematics
File Size : 24. 67 MB
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Crossover Designs: Testing, Estimation and Sample Size Kung-Jong Lui, Department of Mathematics and Statistics, San Diego State University, USA 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: l Provides exact test procedures and interval estimators, which are especially of use in small-sample cases. l 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. l Each chapter is self-contained, allowing the book to be used a reference resource. l Uses real-life examples to illustrate the practical use of test procedures and estimators l 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.

Data Monitoring Committees In Clinical Trials

Author : Susan S. Ellenberg
ISBN : 9781119512646
Genre : Medical
File Size : 25. 33 MB
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­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.

Amstat News

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ISBN : UOM:39015035151946
Genre : Statistics
File Size : 81. 26 MB
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Oncology Clinical Trials

Author : Susan Halabi, PhD
ISBN : 1935281763
Genre : Medical
File Size : 73. 15 MB
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Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial. Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials. Oncology Clinical Trials features: A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis Real-life examples from reported clinical trials included throughout

Journal Of The American Statistical Association

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ISBN : UOM:39015072641353
Genre : Statistics
File Size : 83. 50 MB
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Biostatistics In Clinical Trials

Author : Carol K. Redmond
ISBN : UOM:39015053123363
Genre : Mathematics
File Size : 22. 89 MB
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The second volume in the Wiley reference series inBiostatistics. Featuring articles from the prestigious Encyclopedia ofBiostatistics, many of which have been fully revised and updated toinclude recent developments, Biostatistics in Clinical Trials alsoincludes up to 25% newly commissioned material reflecting thelatest 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 beendesigned to complement existing texts by providing extensive,up-to-date coverage and introducing the reader to the researchliterature. Offering comprehensive coverage of all aspects of clinical trialsBiostatistics in Clinical Trials: Includes concise definitions and introductions to numerousconcepts found in current literature Discusses the software and textbooks available Uses extensive cross-references helping to facilitate furtherresearch and enabling the reader to locate definitions and relatedconcepts Biostatistics in Clinical Trials offers both academics andpractitioners from various disciplines and settings, such asuniversities, the pharmaceutical industry and clinical researchorganisations, up-to-date information as well as references toassist professionals involved in the design and conduct of clinicaltrials.

An Introduction To Optimal Designs For Social And Biomedical Research

Author : Martijn P.F. Berger
ISBN : 0470746920
Genre : Mathematics
File Size : 21. 56 MB
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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.

Well Controlled Diet Studies In Humans

Author : Barbara H. Dennis
ISBN : WISC:89063844872
Genre : Medical
File Size : 61. 64 MB
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This comprehensive and practical volume reviews everything you need to know to design, implement, and manage human research studies. The 25 chapters are grouped into five sections: Study Design, Human Factors, The Dietary Intervention, The Research Kitchen, and Enhancing the Ou tcomes of Dietary Studies. Comprehensive resources, including numerou s figures, tables, and bibliographies accompany each chapter.


Author : Alfonso R. Gennaro
ISBN : UOM:39015052074781
Genre : Pharmacy
File Size : 62. 6 MB
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The Annals Of Pharmacotherapy

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ISBN : NWU:35558003846926
Genre :
File Size : 61. 13 MB
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