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Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309494885
Category : Medical
Languages : en
Pages : 127
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Book Description
Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309494885
Category : Medical
Languages : en
Pages : 127
Get Book Here
Book Description
Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.
Author: Mary Theresa Vidal
Publisher:
ISBN:
Category :
Languages : en
Pages : 406
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Book Description
Author: Stuart J. Pocock
Publisher: John Wiley & Sons
ISBN: 1118794109
Category : Medical
Languages : en
Pages : 228
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Book Description
This comprehensive, unified text on the principles and practice of clinical trials presents a detailed account of how to conduct the trials. It describes the design, analysis, and interpretation of clinical trials in a non-technical manner and provides a general perspective on their historical development, current status, and future strategy. Features examples derived from the author's personal experience.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309442583
Category : Medical
Languages : en
Pages : 111
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Book Description
On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future.
Author: Lawrence M. Friedman
Publisher: Springer Science & Business Media
ISBN: 9780387985862
Category : Medical
Languages : en
Pages : 384
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Book Description
This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors.
Author: Stephen S. Senn
Publisher: John Wiley & Sons
ISBN: 0470854588
Category : Mathematics
Languages : en
Pages : 364
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Book Description
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.
Author: Peter G. Smith
Publisher:
ISBN: 0198732864
Category : Health & Fitness
Languages : en
Pages : 479
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Book Description
This is an open access title available under the terms of a CC BY-NC 4.0 International licence. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. Before new interventions are released into disease control programmes, it is essential that they are carefully evaluated in field trials'. These may be complex and expensive undertakings, requiring the follow-up of hundreds, or thousands, of individuals, often for long periods. Descriptions of the detailed procedures and methods used in the trials that have been conducted have rarely been published. A consequence of this, individuals planning such trials have few guidelines available and little access to knowledge accumulated previously, other than their own. In this manual, practical issues in trial design and conduct are discussed fully and in sufficient detail, that Field Trials of Health Interventions may be used as a toolbox' by field investigators. It has been compiled by an international group of over 30 authors with direct experience in the design, conduct, and analysis of field trials in low and middle income countries and is based on their accumulated knowledge and experience. Available as an open access book via Oxford Medicine Online, this new edition is a comprehensive revision, incorporating the new developments that have taken place in recent years with respect to trials, including seven new chapters on subjects ranging from trial governance, and preliminary studies to pilot testing.
Author: Joseph Tal
Publisher: Academic Press
ISBN: 0123869099
Category : Mathematics
Languages : en
Pages : 279
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Book Description
Delineates the statistical building blocks and concepts of clinical trials.
Author: Anne Whitehead
Publisher: John Wiley & Sons
ISBN: 0470854197
Category : Mathematics
Languages : en
Pages : 352
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Book Description
Over the last twenty years there has been a dramatic upsurge in the application of meta-analysis to medical research. This has mainly been due to greater emphasis on evidence-based medicine and the need for reliable summaries of the vast and expanding volume of clinical research. At the same time there have been great strides in the development and refinement of the associated statistical methodology. This book describes the planning, conduct and reporting of a meta-analysis as applied to a series of randomized controlled clinical trials. * The various approaches are presented within a general unified framework. * Meta-analysis techniques are described in detail, from their theoretical development through to practical implementation. * Each topic discussed is supported by detailed worked examples. * A comparison of fixed and random effects approaches is included, as well as a discussion of Bayesian methods and cumulative meta-analysis. * Fully documented programs using standard statistical procedures in SAS are available on the Web. Ideally suited for practising statisticians and statistically-minded medical professionals, the book will also be of use to graduate students of medical statistics. The book is a self-contained and comprehensive account of the subject and an essential purchase for anyone involved in clinical trials.
Author: William F. Rosenberger
Publisher: John Wiley & Sons
ISBN: 1118742249
Category : Mathematics
Languages : en
Pages : 284
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Book Description
Praise for the First Edition “All medical statisticians involved in clinical trials should read this book...” - Controlled Clinical Trials Featuring a unique combination of the applied aspects of randomization in clinical trials with a nonparametric approach to inference, Randomization in Clinical Trials: Theory and Practice, Second Edition is the go-to guide for biostatisticians and pharmaceutical industry statisticians. Randomization in Clinical Trials: Theory and Practice, Second Edition features: Discussions on current philosophies, controversies, and new developments in the increasingly important role of randomization techniques in clinical trials A new chapter on covariate-adaptive randomization, including minimization techniques and inference New developments in restricted randomization and an increased focus on computation of randomization tests as opposed to the asymptotic theory of randomization tests Plenty of problem sets, theoretical exercises, and short computer simulations using SAS® to facilitate classroom teaching, simplify the mathematics, and ease readers’ understanding Randomization in Clinical Trials: Theory and Practice, Second Edition is an excellent reference for researchers as well as applied statisticians and biostatisticians. The Second Edition is also an ideal textbook for upper-undergraduate and graduate-level courses in biostatistics and applied statistics. William F. Rosenberger, PhD, is University Professor and Chairman of the Department of Statistics at George Mason University. He is a Fellow of the American Statistical Association and the Institute of Mathematical Statistics, and author of over 80 refereed journal articles, as well as The Theory of Response-Adaptive Randomization in Clinical Trials, also published by Wiley. John M. Lachin, ScD, is Research Professor in the Department of Epidemiology and Biostatistics as well as in the Department of Statistics at The George Washington University. A Fellow of the American Statistical Association and the Society for Clinical Trials, Dr. Lachin is actively involved in coordinating center activities for clinical trials of diabetes. He is the author of Biostatistical Methods: The Assessment of Relative Risks, Second Edition, also published by Wiley.
