Selection Bias And Covariate Imbalances In Randomized Clinical Trials
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Selection Bias And Covariate Imbalances In Randomized Clinical Trials
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Author : Vance Berger
language : en
Publisher: John Wiley & Sons
Release Date : 2007-10-22
Selection Bias And Covariate Imbalances In Randomized Clinical Trials written by Vance Berger and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-10-22 with Mathematics categories.
Selection bias can, and does, occur, even in randomized clinical trials. Steps need to be taken in order to ensure that this does not compromise the integrity of clinical trials; hence “Selection Bias and Covariate Imbalances in Randomized Clinical Trials” offers a comprehensive treatment of the subject and the methodology involved. This book: Provides an overview of the hierarchy of study designs, and justifies the position of randomised trials at the top of this hierarchy. Discusses the strengths and defects of randomisation, and provides real evidence to justify concern regarding its defects. Outlays the damaging consequences that selection bias causes when it does occur. Considers courses of action that can be taken to manage/ contain the problem. Presents methods that can be used to detect selection bias in randomised trials, and methods to correct for selection bias. Concludes by providing a comprehensive plan for managing baseline imbalances and selection bias in randomised trials, and proposing open problems for future research. Illustrated with case studies, this book introduces groundbreaking ideas and research that will be invaluable to researchers and practitioners who design and analyse clinical trials. It will also be of interest to graduate students within the field of biostatistics.
Randomization In Clinical Trials
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Author : William F. Rosenberger
language : en
Publisher: John Wiley & Sons
Release Date : 2015-11-23
Randomization In Clinical Trials written by William F. Rosenberger and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-11-23 with Mathematics categories.
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.
Modern Adaptive Randomized Clinical Trials
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Author : Oleksandr Sverdlov
language : en
Publisher: CRC Press
Release Date : 2015-06-30
Modern Adaptive Randomized Clinical Trials written by Oleksandr Sverdlov and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-06-30 with Mathematics categories.
Is adaptive randomization always better than traditional fixed-schedule randomization? Which procedures should be used and under which circumstances? What special considerations are required for adaptive randomized trials? What kind of statistical inference should be used to achieve valid and unbiased treatment comparisons following adaptive random
Clinical Trials
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Author : Steven Piantadosi
language : en
Publisher: John Wiley & Sons
Release Date : 2024-04-03
Clinical Trials written by Steven Piantadosi and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-04-03 with Mathematics categories.
Clinical Trials Comprehensive resource presenting methods essential in planning, designing, conducting, analyzing, and interpreting clinical trials The Fourth Edition of Clinical Trials builds on the text’s reputation as a straightforward, detailed, and authoritative presentation of quantitative methods for clinical trials, discussing principles of design for various types of clinical trials and elements of planning the experiment, assembling a study cohort, assessing data, and reporting results. Each chapter contains an introduction and summary to reinforce key points. Discussion questions stimulate critical thinking and help readers understand how they can apply their newfound knowledge. Written by a highly qualified author with significant experience in the field, the Fourth Edition of Clinical Trials approaches the topic with: Problems that may arise during a trial, and accompanying common sense solutions Design alternatives for addressing many questions in therapeutic development Statistical principles with new and provocative topics, such as generalizing results, operating characteristics, trial issues during the COVID-19 pandemic, and more Alternative medicine, ethics, middle development, comparative studies, adaptive designs, and clinical trials using point of care data Revamped exercise sets, updated and extensive references, new material on endpoints and the developmental pipeline, and revisions of numerous sections, tables, and figures Standing out due to its accessible and broad coverage of statistical design methods which are the building blocks of clinical trials and medical research, Clinical Trials is an essential learning aid on the subject for undergraduate and graduate clinical trials courses.
Principles And Practice Of Clinical Trials
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Author : Steven Piantadosi
language : en
Publisher: Springer Nature
Release Date : 2022-07-19
Principles And Practice Of Clinical Trials written by Steven Piantadosi and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-07-19 with Medical categories.
This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.
Data Monitoring Committees In Clinical Trials
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Author : Susan S. Ellenberg
language : en
Publisher: John Wiley & Sons
Release Date : 2019-01-15
Data Monitoring Committees In Clinical Trials written by Susan S. Ellenberg and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-01-15 with Medical categories.
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.
A Manager S Guide To The Design And Conduct Of Clinical Trials
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Author : Phillip I. Good
language : en
Publisher: John Wiley & Sons
Release Date : 2006-04-21
A Manager S Guide To The Design And Conduct Of Clinical Trials written by Phillip I. Good and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-04-21 with Mathematics categories.
This newly updated edition of the benchmark guide to computer-assisted clinical trials provides a comprehensive primer for prospective managers. It covers every critical issue of the design and conduct of clinical trials, including study design, organization, regulatory agency liaison, data collection and analysis, as well as recruitment, software, monitoring, and reporting. Keeping the same user-friendly format as the original, this Second Edition features new examples and the latest developments in regulatory guidelines, such as e-submission procedures and computerized direct data acquisition. The new edition also reflects the increasing globalization of clinical trial activities, and includes new information about international standards and procedures, including the Common Technical Document and CDISC standards. This step-by-step guide is supported by handy checklists and extracts from submitted protocols. Experienced author and consultant Phillip Good incorporateshumorous yet instructive anecdotes to illustrate common pitfalls. Based on the proven industrial formula of planning, implementing, and finally performing essential checks, the book's three sections-"Plan," "Do," and "Check"-includethe following material: * Should the trials be conducted? * Put it in the computer and keep it there * Staffing for success * Designing trials and determining sample size * Budgeting * Recruiting and retaining patients and physicians * Data management * Monitoring the trials * Data analysis * After action review * Exception handling Executive and managerial professionals involved in the design and analysis of clinical experiments, along with clinical research associates, biostatisticians, and students in public health will find A Manager's Guide an indispensable resource. Praise for the First Edition: ". . . readable, informative and at times witty . . . never stops being concise and well written . . . a book worth a read . . ." -Statistics in Medicine "The book is very prescriptive and full of lists and tables with which to guide managers in making effective decisions in using computer-assisted clinical trials in pharmaceutical studies." -Technometrics "This book is must-have reading for anyone in the business . . ." -Clinical Chemistry
Designing Randomised Trials In Health Education And The Social Sciences
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Author : D. Torgerson
language : en
Publisher: Springer
Release Date : 2008-03-13
Designing Randomised Trials In Health Education And The Social Sciences written by D. Torgerson and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-03-13 with Social Science categories.
The book focuses on the design of rigorous trials rather than their statistical underpinnings, with chapters on: pragmatic designs; placebo designs; preference approaches; unequal allocation; economics; analytical approaches; randomization methods. It also includes a detailed description of randomization procedures and different trial designs.
Evidence Based Physical Therapy For The Pelvic Floor E Book
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Author : Kari Bø
language : en
Publisher: Elsevier Health Sciences
Release Date : 2023-11-24
Evidence Based Physical Therapy For The Pelvic Floor E Book written by Kari Bø and has been published by Elsevier Health Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-11-24 with Medical categories.
Written by leading experts in this field, Evidence-Based Physical Therapy for the Pelvic Floor provides physiotherapists and other professionals with knowledge and confidence to bring the latest evidence-based approaches and treatment strategies for addressing pelvic floor dysfunction to their practice. Fully updated and with a wealth of new information, this edition includes sections on devices and apps, gynaecological cancer, sexual dysfunction, fistula, clinical use of EMG, anal incontinence and pain, as well as a discussion of sexualized violence by Nobel Peace Prize winner Denis Mugwege and his team. - New and fully updated contents; new authors and new chapters provide contemporary evidence - Innovative practice guidelines supported by a sound evidence base - Colour illustrations of pelvic floor anatomy and related neuroanatomy/neurophysiology - MRIs and ultrasounds showing normal and dysfunctional pelvic floor - Key summaries for easy navigation - Full colour throughout
Handbook Of Behavioral Medicine
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Author : Andrew Steptoe
language : en
Publisher: Springer Science & Business Media
Release Date : 2010-09-27
Handbook Of Behavioral Medicine written by Andrew Steptoe and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-09-27 with Psychology categories.
Behavioral medicine emerged in the 1970s as the interdisciplinary field concerned with the integration of behavioral, psychosocial, and biomedical science knowledge relevant to the understanding of health and illness, and the application of this knowledge to prevention, diagnosis, treatment, and rehabilitation. Recent years have witnessed an enormous diversification of behavioral medicine, with new sciences (such as genetics, life course epidemiology) and new technologies (such as neuroimaging) coming into play. This book brings together such new developments by providing an up-to-date compendium of methods and applications drawn from the broad range of behavioral medicine research and practice. The book is divided into 10 sections that address key fields in behavioral medicine. Each section begins with one or two methodological or conceptual chapters, followed by contributions that address substantive topics within that field. Major health problems such as cardiovascular disease, cancer, HIV/AIDs, and obesity are explored from multiple perspectives. The aim is to present behavioral medicine as an integrative discipline, involving diverse methodologies and paradigms that converge on health and well being.