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Selection Bias And Covariate Imbalances In Randomized Clinical Trials
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Book Synopsis Selection Bias and Covariate Imbalances in Randomized Clinical Trials by : Vance Berger
Download or read book Selection Bias and Covariate Imbalances in Randomized Clinical Trials written by Vance Berger and published by John Wiley & Sons. This book was released on 2007-10-22 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Randomization in Clinical Trials by : William F. Rosenberger
Download or read book Randomization in Clinical Trials written by William F. Rosenberger and published by John Wiley & Sons. This book was released on 2015-11-23 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Cochrane Handbook for Systematic Reviews of Interventions by : Julian P. T. Higgins
Download or read book Cochrane Handbook for Systematic Reviews of Interventions written by Julian P. T. Higgins and published by Wiley. This book was released on 2008-11-24 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis A Practical Guide to Cluster Randomised Trials in Health Services Research by : Sandra Eldridge
Download or read book A Practical Guide to Cluster Randomised Trials in Health Services Research written by Sandra Eldridge and published by John Wiley & Sons. This book was released on 2012-02-20 with total page 299 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Cross-over Trials in Clinical Research by : Stephen S. Senn
Download or read book Cross-over Trials in Clinical Research written by Stephen S. Senn and published by John Wiley & Sons. This book was released on 2003-07-25 with total page 364 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Propensity Score Analysis by : Shenyang Guo
Download or read book Propensity Score Analysis written by Shenyang Guo and published by SAGE. This book was released on 2015 with total page 449 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Clinical Trial Design by : Guosheng Yin
Download or read book Clinical Trial Design written by Guosheng Yin and published by John Wiley & Sons. This book was released on 2013-06-07 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: A balanced treatment of the theories, methodologies, and design issues involved in clinical trials using statistical methods There has been enormous interest and development in Bayesian adaptive designs, especially for early phases of clinical trials. However, for phase III trials, frequentist methods still play a dominant role through controlling type I and type II errors in the hypothesis testing framework. From practical perspectives, Clinical Trial Design: Bayesian and Frequentist Adaptive Methods provides comprehensive coverage of both Bayesian and frequentist approaches to all phases of clinical trial design. Before underpinning various adaptive methods, the book establishes an overview of the fundamentals of clinical trials as well as a comparison of Bayesian and frequentist statistics. Recognizing that clinical trial design is one of the most important and useful skills in the pharmaceutical industry, this book provides detailed discussions on a variety of statistical designs, their properties, and operating characteristics for phase I, II, and III clinical trials as well as an introduction to phase IV trials. Many practical issues and challenges arising in clinical trials are addressed. Additional topics of coverage include: Risk and benefit analysis for toxicity and efficacy trade-offs Bayesian predictive probability trial monitoring Bayesian adaptive randomization Late onset toxicity and response Dose finding in drug combination trials Targeted therapy designs The author utilizes cutting-edge clinical trial designs and statistical methods that have been employed at the world's leading medical centers as well as in the pharmaceutical industry. The software used throughout the book is freely available on the book's related website, equipping readers with the necessary tools for designing clinical trials. Clinical Trial Design is an excellent book for courses on the topic at the graduate level. The book also serves as a valuable reference for statisticians and biostatisticians in the pharmaceutical industry as well as for researchers and practitioners who design, conduct, and monitor clinical trials in their everyday work.
Author :Agency for Health Care Research and Quality (U.S.) Publisher :Government Printing Office ISBN 13 :1587634236 Total Pages :236 pages Book Rating :4.5/5 (876 download)
Book Synopsis Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide by : Agency for Health Care Research and Quality (U.S.)
Download or read book Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide written by Agency for Health Care Research and Quality (U.S.) and published by Government Printing Office. This book was released on 2013-02-21 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)
Download or read book Randomistas written by Andrew Leigh and published by Yale University Press. This book was released on 2018-07-24 with total page 283 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Analysis of Clinical Trials Using SAS by : Alex Dmitrienko
Download or read book Analysis of Clinical Trials Using SAS written by Alex Dmitrienko and published by SAS Institute. This book was released on 2017-07-17 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt: Analysis of Clinical Trials Using SAS®: A Practical Guide, Second Edition bridges the gap between modern statistical methodology and real-world clinical trial applications. Tutorial material and step-by-step instructions illustrated with examples from actual trials serve to define relevant statistical approaches, describe their clinical trial applications, and implement the approaches rapidly and efficiently using the power of SAS. Topics reflect the International Conference on Harmonization (ICH) guidelines for the pharmaceutical industry and address important statistical problems encountered in clinical trials. Commonly used methods are covered, including dose-escalation and dose-finding methods that are applied in Phase I and Phase II clinical trials, as well as important trial designs and analysis strategies that are employed in Phase II and Phase III clinical trials, such as multiplicity adjustment, data monitoring, and methods for handling incomplete data. This book also features recommendations from clinical trial experts and a discussion of relevant regulatory guidelines. This new edition includes more examples and case studies, new approaches for addressing statistical problems, and the following new technological updates: SAS procedures used in group sequential trials (PROC SEQDESIGN and PROC SEQTEST) SAS procedures used in repeated measures analysis (PROC GLIMMIX and PROC GEE) macros for implementing a broad range of randomization-based methods in clinical trials, performing complex multiplicity adjustments, and investigating the design and analysis of early phase trials (Phase I dose-escalation trials and Phase II dose-finding trials) Clinical statisticians, research scientists, and graduate students in biostatistics will greatly benefit from the decades of clinical research experience and the ready-to-use SAS macros compiled in this book.
Book Synopsis Methods and Applications of Statistics in Clinical Trials, Volume 2 by : Narayanaswamy Balakrishnan
Download or read book Methods and Applications of Statistics in Clinical Trials, Volume 2 written by Narayanaswamy Balakrishnan and published by John Wiley & Sons. This book was released on 2014-06-09 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods includes updates of established literature from the Wiley Encyclopedia of Clinical Trials as well as original material based on the latest developments in clinical trials. Prepared by a leading expert, the second volume includes numerous contributions from current prominent experts in the field of medical research. In addition, the volume features: • Multiple new articles exploring emerging topics, such as evaluation methods with threshold, empirical likelihood methods, nonparametric ROC analysis, over- and under-dispersed models, and multi-armed bandit problems • Up-to-date research on the Cox proportional hazard model, frailty models, trial reports, intrarater reliability, conditional power, and the kappa index • Key qualitative issues including cost-effectiveness analysis, publication bias, and regulatory issues, which are crucial to the planning and data management of clinical trials
Book Synopsis Randomization Tests by : Eugene S. Edgington
Download or read book Randomization Tests written by Eugene S. Edgington and published by . This book was released on 1980 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: Random assignment; Calculating significance values; One-way analysis of variance and the independent t test; Repeated-measures analysis of variance and the correlated t test; Factorial designs; Multivariate designs; Correlation; Trend tests; One-subject randomization tests.
Book Synopsis Prognosis Research in Healthcare by : Richard D. Riley
Download or read book Prognosis Research in Healthcare written by Richard D. Riley and published by Oxford University Press. This book was released on 2019-01-17 with total page 373 pages. Available in PDF, EPUB and Kindle. Book excerpt: "What is going to happen to me?" Most patients ask this question during a clinical encounter with a health professional. As well as learning what problem they have (diagnosis) and what needs to be done about it (treatment), patients want to know about their future health and wellbeing (prognosis). Prognosis research can provide answers to this question and satisfy the need for individuals to understand the possible outcomes of their condition, with and without treatment. Central to modern medical practise, the topic of prognosis is the basis of decision making in healthcare and policy development. It translates basic and clinical science into practical care for patients and populations. Prognosis Research in Healthcare: Concepts, Methods and Impact provides a comprehensive overview of the field of prognosis and prognosis research and gives a global perspective on how prognosis research and prognostic information can improve the outcomes of healthcare. It details how to design, carry out, analyse and report prognosis studies, and how prognostic information can be the basis for tailored, personalised healthcare. In particular, the book discusses how information about the characteristics of people, their health, and environment can be used to predict an individual's future health. Prognosis Research in Healthcare: Concepts, Methods and Impact, addresses all types of prognosis research and provides a practical step-by-step guide to undertaking and interpreting prognosis research studies, ideal for medical students, health researchers, healthcare professionals and methodologists, as well as for guideline and policy makers in healthcare wishing to learn more about the field of prognosis.
Book Synopsis Recent Advances in Clinical Trial Design and Analysis by : Peter F. Thall
Download or read book Recent Advances in Clinical Trial Design and Analysis written by Peter F. Thall and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 263 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials have two purposes -- to treat the patients in the trial, and to obtain information which increases our understanding of the disease and especially how patients respond to treatment. Statistical design provides a means to achieve both these aims, while statistical data analysis provides methods for extracting useful information from the trial data. Recent advances in statistical computing have enabled statisticians to implement very rapidly a broad array of methods which previously were either impractical or impossible. Biostatisticians are now able to provide much greater support to medical researchers working in both clinical and laboratory settings. As our collective toolkit of techniques for analyzing data has grown, it has become increasingly difficult for biostatisticians to keep up with all the developments in our own field. Recent Advances in Clinical Trial Design and Analysis brings together biostatisticians doing cutting-edge research and explains some of the more recent developments in biostatistics to clinicians and scientists who work in clinical trials.
Book Synopsis Field Trials of Health Interventions by : Peter G. Smith
Download or read book Field Trials of Health Interventions written by Peter G. Smith and published by . This book was released on 2015 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Statistical Issues in Drug Development by : Stephen S. Senn
Download or read book Statistical Issues in Drug Development written by Stephen S. Senn and published by John Wiley & Sons. This book was released on 2008-02-28 with total page 523 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug development is the process of finding and producingtherapeutically useful pharmaceuticals, turning them into safe andeffective medicine, and producing reliable information regardingthe appropriate dosage and dosing intervals. With regulatoryauthorities demanding increasingly higher standards in suchdevelopments, statistics has become an intrinsic and criticalelement in the design and conduct of drug development programmes. Statistical Issues in Drug Development presents anessential and thought provoking guide to the statistical issues andcontroversies involved in drug development. This highly readable second edition has been updated toinclude: Comprehensive coverage of the design and interpretation ofclinical trials. Expanded sections on missing data, equivalence, meta-analysisand dose finding. An examination of both Bayesian and frequentist methods. A new chapter on pharmacogenomics and expanded coverage ofpharmaco-epidemiology and pharmaco-economics. Coverage of the ICH guidelines, in particular ICH E9,Statistical Principles for Clinical Trials. It is hoped that the book will stimulate dialogue betweenstatisticians and life scientists working within the pharmaceuticalindustry. The accessible and wide-ranging coverage make itessential reading for both statisticians and non-statisticiansworking in the pharmaceutical industry, regulatory bodies andmedical research institutes. There is also much to benefitundergraduate and postgraduate students whose courses include amedical statistics component.
Author :Lawrence M. Friedman Publisher :Springer Science & Business Media ISBN 13 :9780387985862 Total Pages :384 pages Book Rating :4.9/5 (858 download)
Book Synopsis Fundamentals of Clinical Trials by : Lawrence M. Friedman
Download or read book Fundamentals of Clinical Trials written by Lawrence M. Friedman and published by Springer Science & Business Media. This book was released on 1998 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
