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Selection Bias and Covariate Imbalances in Randomized Clinical Trials

Selection Bias and Covariate Imbalances in Randomized Clinical Trials
Author: Vance Berger
Publisher: John Wiley & Sons
Total Pages: 218
Release: 2007-10-22
Genre: Mathematics
ISBN: 0470863633

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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

Randomization in Clinical Trials
Author: William F. Rosenberger
Publisher: John Wiley & Sons
Total Pages: 284
Release: 2015-11-23
Genre: Mathematics
ISBN: 1118742249

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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.


Cochrane Handbook for Systematic Reviews of Interventions

Cochrane Handbook for Systematic Reviews of Interventions
Author: Julian P. T. Higgins
Publisher: Wiley
Total Pages: 672
Release: 2008-11-24
Genre: Medical
ISBN: 9780470699515

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Healthcare providers, consumers, researchers and policy makers are inundated with unmanageable amounts of information, including evidence from healthcare research. It has become impossible for all to have the time and resources to find, appraise and interpret this evidence and incorporate it into healthcare decisions. Cochrane Reviews respond to this challenge by identifying, appraising and synthesizing research-based evidence and presenting it in a standardized format, published in The Cochrane Library (www.thecochranelibrary.com). The Cochrane Handbook for Systematic Reviews of Interventions contains methodological guidance for the preparation and maintenance of Cochrane intervention reviews. Written in a clear and accessible format, it is the essential manual for all those preparing, maintaining and reading Cochrane reviews. Many of the principles and methods described here are appropriate for systematic reviews applied to other types of research and to systematic reviews of interventions undertaken by others. It is hoped therefore that this book will be invaluable to all those who want to understand the role of systematic reviews, critically appraise published reviews or perform reviews themselves.


Design and Analysis of Group-randomized Trials

Design and Analysis of Group-randomized Trials
Author: David M. Murray
Publisher: Monographs in Epidemiology and
Total Pages: 481
Release: 1998
Genre: Medical
ISBN: 0195120361

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Community or group-randomized trials, which are usually done to evaluate the effect of health promotion effors. It reviews the underlying issues, describes the most widely used research design, and presents the many approaches to analysis that are now available.


A Practical Guide to Cluster Randomised Trials in Health Services Research

A Practical Guide to Cluster Randomised Trials in Health Services Research
Author: Sandra Eldridge
Publisher: John Wiley & Sons
Total Pages: 299
Release: 2012-02-20
Genre: Medical
ISBN: 0470510471

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Cluster randomised trials are trials in which groups (or clusters) of individuals are randomly allocated to different forms of treatment. In health care, these trials often compare different ways of managing a disease or promoting healthy living, in contrast to conventional randomised trials which randomise individuals to different treatments, classically comparing new drugs with a placebo. They are increasingly common in health services research. This book addresses the statistical, practical, and ethical issues arising from allocating groups of individuals, or clusters, to different interventions. Key features: Guides readers through the stages of conducting a trial, from recruitment to reporting. Presents a wide range of examples with particular emphasis on trials in health services research and primary care, with both principles and techniques explained. Topics are specifically presented in the order in which investigators think about issues when they are designing a trial. Combines information on the latest developments in the field together with a practical guide to the design and implementation of cluster randomised trials. Explains principles and techniques through numerous examples including many from the authors own experience. Includes a wide range of references for those who wish to read further. This book is intended as a practical guide, written for researchers from the health professions including doctors, psychologists, and allied health professionals, as well as statisticians involved in the design, execution, analysis and reporting of cluster randomised trials. Those with a more general interest will find the plentiful examples illuminating.


Propensity Score Analysis

Propensity Score Analysis
Author: Shenyang Guo
Publisher: SAGE
Total Pages: 449
Release: 2015
Genre: Business & Economics
ISBN: 1452235007

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Provides readers with a systematic review of the origins, history, and statistical foundations of Propensity Score Analysis (PSA) and illustrates how it can be used for solving evaluation and causal-inference problems.


Principles and Practice of Clinical Trials

Principles and Practice of Clinical Trials
Author: Steven Piantadosi
Publisher: Springer Nature
Total Pages: 2573
Release: 2022-07-19
Genre: Medical
ISBN: 3319526367

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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.


Modern Adaptive Randomized Clinical Trials

Modern Adaptive Randomized Clinical Trials
Author: Oleksandr Sverdlov
Publisher: CRC Press
Total Pages: 536
Release: 2015-06-30
Genre: Mathematics
ISBN: 1482239892

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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


Randomistas

Randomistas
Author: Andrew Leigh
Publisher: Yale University Press
Total Pages: 283
Release: 2018-07-24
Genre: Social Science
ISBN: 0300240112

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A fascinating account of how radical researchers have used experiments to overturn conventional wisdom and shaped life as we know it Experiments have consistently been used in the hard sciences, but in recent decades social scientists have adopted the practice. Randomized trials have been used to design policies to increase educational attainment, lower crime rates, elevate employment rates, and improve living standards among the poor. This book tells the stories of radical researchers who have used experiments to overturn conventional wisdom. From finding the cure for scurvy to discovering what policies really improve literacy rates, Leigh shows how randomistas have shaped life as we know it. Written in a “Gladwell-esque” style, this book provides a fascinating account of key randomized control trial studies from across the globe and the challenges that randomistas have faced in getting their studies accepted and their findings implemented. In telling these stories, Leigh draws out key lessons learned and shows the most effective way to conduct these trials.