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The Prevention And Treatment Of Missing Data In Clinical Trials
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Book Synopsis The Prevention and Treatment of Missing Data in Clinical Trials by : National Research Council
Download or read book The Prevention and Treatment of Missing Data in Clinical Trials written by National Research Council and published by National Academies Press. This book was released on 2010-12-21 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.
Book Synopsis Preventing and Treating Missing Data in Longitudinal Clinical Trials by : Craig H. Mallinckrodt
Download or read book Preventing and Treating Missing Data in Longitudinal Clinical Trials written by Craig H. Mallinckrodt and published by Cambridge University Press. This book was released on 2013-01-28 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent decades have brought advances in statistical theory for missing data, which, combined with advances in computing ability, have allowed implementation of a wide array of analyses. In fact, so many methods are available that it can be difficult to ascertain when to use which method. This book focuses on the prevention and treatment of missing data in longitudinal clinical trials. Based on his extensive experience with missing data, the author offers advice on choosing analysis methods and on ways to prevent missing data through appropriate trial design and conduct. He offers a practical guide to key principles and explains analytic methods for the non-statistician using limited statistical notation and jargon. The book's goal is to present a comprehensive strategy for preventing and treating missing data, and to make available the programs used to conduct the analyses of the example dataset.
Book Synopsis The Prevention and Treatment of Missing Data in Clinical Trials by : National Research Council
Download or read book The Prevention and Treatment of Missing Data in Clinical Trials written by National Research Council and published by National Academies Press. This book was released on 2011-01-21 with total page 162 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.
Book Synopsis Missing Data by : Patrick E. McKnight
Download or read book Missing Data written by Patrick E. McKnight and published by Guilford Press. This book was released on 2007-03-28 with total page 269 pages. Available in PDF, EPUB and Kindle. Book excerpt: While most books on missing data focus on applying sophisticated statistical techniques to deal with the problem after it has occurred, this volume provides a methodology for the control and prevention of missing data. In clear, nontechnical language, the authors help the reader understand the different types of missing data and their implications for the reliability, validity, and generalizability of a study’s conclusions. They provide practical recommendations for designing studies that decrease the likelihood of missing data, and for addressing this important issue when reporting study results. When statistical remedies are needed--such as deletion procedures, augmentation methods, and single imputation and multiple imputation procedures--the book also explains how to make sound decisions about their use. Patrick E. McKnight's website offers a periodically updated annotated bibliography on missing data and links to other Web resources that address missing data.
Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Book Synopsis Flexible Imputation of Missing Data, Second Edition by : Stef van Buuren
Download or read book Flexible Imputation of Missing Data, Second Edition written by Stef van Buuren and published by CRC Press. This book was released on 2018-07-17 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: Missing data pose challenges to real-life data analysis. Simple ad-hoc fixes, like deletion or mean imputation, only work under highly restrictive conditions, which are often not met in practice. Multiple imputation replaces each missing value by multiple plausible values. The variability between these replacements reflects our ignorance of the true (but missing) value. Each of the completed data set is then analyzed by standard methods, and the results are pooled to obtain unbiased estimates with correct confidence intervals. Multiple imputation is a general approach that also inspires novel solutions to old problems by reformulating the task at hand as a missing-data problem. This is the second edition of a popular book on multiple imputation, focused on explaining the application of methods through detailed worked examples using the MICE package as developed by the author. This new edition incorporates the recent developments in this fast-moving field. This class-tested book avoids mathematical and technical details as much as possible: formulas are accompanied by verbal statements that explain the formula in accessible terms. The book sharpens the reader’s intuition on how to think about missing data, and provides all the tools needed to execute a well-grounded quantitative analysis in the presence of missing data.
Book Synopsis Handbook of Missing Data Methodology by : Geert Molenberghs
Download or read book Handbook of Missing Data Methodology written by Geert Molenberghs and published by CRC Press. This book was released on 2014-11-06 with total page 600 pages. Available in PDF, EPUB and Kindle. Book excerpt: Missing data affect nearly every discipline by complicating the statistical analysis of collected data. But since the 1990s, there have been important developments in the statistical methodology for handling missing data. Written by renowned statisticians in this area, Handbook of Missing Data Methodology presents many methodological advances and the latest applications of missing data methods in empirical research. Divided into six parts, the handbook begins by establishing notation and terminology. It reviews the general taxonomy of missing data mechanisms and their implications for analysis and offers a historical perspective on early methods for handling missing data. The following three parts cover various inference paradigms when data are missing, including likelihood and Bayesian methods; semi-parametric methods, with particular emphasis on inverse probability weighting; and multiple imputation methods. The next part of the book focuses on a range of approaches that assess the sensitivity of inferences to alternative, routinely non-verifiable assumptions about the missing data process. The final part discusses special topics, such as missing data in clinical trials and sample surveys as well as approaches to model diagnostics in the missing data setting. In each part, an introduction provides useful background material and an overview to set the stage for subsequent chapters. Covering both established and emerging methodologies for missing data, this book sets the scene for future research. It provides the framework for readers to delve into research and practical applications of missing data methods.
Book Synopsis Clinical Trials with Missing Data by : Michael O'Kelly
Download or read book Clinical Trials with Missing Data written by Michael O'Kelly and published by John Wiley & Sons. This book was released on 2014-02-14 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides practical guidance for statisticians, clinicians, and researchers involved in clinical trials in the biopharmaceutical industry, medical and public health organisations. Academics and students needing an introduction to handling missing data will also find this book invaluable. The authors describe how missing data can affect the outcome and credibility of a clinical trial, show by examples how a clinical team can work to prevent missing data, and present the reader with approaches to address missing data effectively. The book is illustrated throughout with realistic case studies and worked examples, and presents clear and concise guidelines to enable good planning for missing data. The authors show how to handle missing data in a way that is transparent and easy to understand for clinicians, regulators and patients. New developments are presented to improve the choice and implementation of primary and sensitivity analyses for missing data. Many SAS code examples are included – the reader is given a toolbox for implementing analyses under a variety of assumptions.
Book Synopsis Clinical Trials in Neurology by : Bernard Ravina
Download or read book Clinical Trials in Neurology written by Bernard Ravina and published by Cambridge University Press. This book was released on 2012-04-12 with total page 387 pages. Available in PDF, EPUB and Kindle. Book excerpt: Translating laboratory discoveries into successful therapeutics can be difficult. Clinical Trials in Neurology aims to improve the efficiency of clinical trials and the development of interventions in order to enhance the development of new treatments for neurologic diseases. It introduces the reader to the key concepts underpinning trials in the neurosciences. This volume tackles the challenges of developing therapies for neurologic disorders from measurement of agents in the nervous system to the progression of clinical signs and symptoms through illustrating specific study designs and their applications to different therapeutic areas. Clinical Trials in Neurology covers key issues in Phase I, II and III clinical trials, as well as post-marketing safety surveillance. Topics addressed include regulatory and implementation issues, outcome measures and common problems in drug development. Written by a multidisciplinary team, this comprehensive guide is essential reading for neurologists, psychiatrists, neurosurgeons, neuroscientists, statisticians and clinical researchers in the pharmaceutical industry.
Book Synopsis Introduction to Statistical Methods for Clinical Trials by : Thomas D. Cook
Download or read book Introduction to Statistical Methods for Clinical Trials written by Thomas D. Cook and published by CRC Press. This book was released on 2007-11-19 with total page 465 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials have become essential research tools for evaluating the benefits and risks of new interventions for the treatment and prevention of diseases, from cardiovascular disease to cancer to AIDS. Based on the authors’ collective experiences in this field, Introduction to Statistical Methods for Clinical Trials presents various statistical topics relevant to the design, monitoring, and analysis of a clinical trial. After reviewing the history, ethics, protocol, and regulatory issues of clinical trials, the book provides guidelines for formulating primary and secondary questions and translating clinical questions into statistical ones. It examines designs used in clinical trials, presents methods for determining sample size, and introduces constrained randomization procedures. The authors also discuss how various types of data must be collected to answer key questions in a trial. In addition, they explore common analysis methods, describe statistical methods that determine what an emerging trend represents, and present issues that arise in the analysis of data. The book concludes with suggestions for reporting trial results that are consistent with universal guidelines recommended by medical journals. Developed from a course taught at the University of Wisconsin for the past 25 years, this textbook provides a solid understanding of the statistical approaches used in the design, conduct, and analysis of clinical trials.
Book Synopsis Adaptive Treatment Strategies in Practice: Planning Trials and Analyzing Data for Personalized Medicine by : Michael R. Kosorok
Download or read book Adaptive Treatment Strategies in Practice: Planning Trials and Analyzing Data for Personalized Medicine written by Michael R. Kosorok and published by SIAM. This book was released on 2015-12-08 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: Personalized medicine is a medical paradigm that emphasizes systematic use of individual patient information to optimize that patient's health care, particularly in managing chronic conditions and treating cancer. In the statistical literature, sequential decision making is known as an adaptive treatment strategy (ATS) or a dynamic treatment regime (DTR). The field of DTRs emerges at the interface of statistics, machine learning, and biomedical science to provide a data-driven framework for precision medicine. The authors provide a learning-by-seeing approach to the development of ATSs, aimed at a broad audience of health researchers. All estimation procedures used are described in sufficient heuristic and technical detail so that less quantitative readers can understand the broad principles underlying the approaches. At the same time, more quantitative readers can implement these practices. This book provides the most up-to-date summary of the current state of the statistical research in personalized medicine; contains chapters by leaders in the area from both the statistics and computer sciences fields; and also contains a range of practical advice, introductory and expository materials, and case studies.
Book Synopsis Design and Analysis of Quality of Life Studies in Clinical Trials by : Diane L. Fairclough
Download or read book Design and Analysis of Quality of Life Studies in Clinical Trials written by Diane L. Fairclough and published by CRC Press. This book was released on 2010-01-07 with total page 419 pages. Available in PDF, EPUB and Kindle. Book excerpt: Design Principles and Analysis Techniques for HRQoL Clinical TrialsSAS, R, and SPSS examples realistically show how to implement methods Focusing on longitudinal studies, Design and Analysis of Quality of Life Studies in Clinical Trials, Second Edition addresses design and analysis aspects in enough detail so that readers can apply statistical meth
Book Synopsis Missing Data in Clinical Studies by : Geert Molenberghs
Download or read book Missing Data in Clinical Studies written by Geert Molenberghs and published by John Wiley & Sons. This book was released on 2007-04-04 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: Missing Data in Clinical Studies provides a comprehensive account of the problems arising when data from clinical and related studies are incomplete, and presents the reader with approaches to effectively address them. The text provides a critique of conventional and simple methods before moving on to discuss more advanced approaches. The authors focus on practical and modeling concepts, providing an extensive set of case studies to illustrate the problems described. Provides a practical guide to the analysis of clinical trials and related studies with missing data. Examines the problems caused by missing data, enabling a complete understanding of how to overcome them. Presents conventional, simple methods to tackle these problems, before addressing more advanced approaches, including sensitivity analysis, and the MAR missingness mechanism. Illustrated throughout with real-life case studies and worked examples from clinical trials. Details the use and implementation of the necessary statistical software, primarily SAS. Missing Data in Clinical Studies has been developed through a series of courses and lectures. Its practical approach will appeal to applied statisticians and biomedical researchers, in particular those in the biopharmaceutical industry, medical and public health organisations. Graduate students of biostatistics will also find much of benefit.
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 Statistical Aspects of the Design and Analysis of Clinical Trials by : Brian S Everitt
Download or read book Statistical Aspects of the Design and Analysis of Clinical Trials written by Brian S Everitt and published by World Scientific. This book was released on 2004-02-26 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt: Fully updated, this revised edition describes the statistical aspects of both the design and analysis of trials, with particular emphasis on the more recent methods of analysis. About 8000 clinical trials are undertaken annually in all areas of medicine, from the treatment of acne to the prevention of cancer. Correct interpretation of the data from such trials depends largely on adequate design and on performing the appropriate statistical analyses. This book provides a useful guide to medical statisticians and others faced with the often difficult problems of designing and analysing clinical trials. Contents:An Introduction to Clinical TrialsTreatment Allocation, the Size of Trials and Reporting ResultsMonitoring Trial Progress: Outcome Measures, Compliance, Dropouts and Interim AnalysesBasic Analyses of Clinical Trials, the Generalised Linear Model and the Economic Evaluation of TrialsSimple Approaches to the Analysis of Longitudinal Data from Clinical TrialsMultivariate Normal Regression Models for Longitudinal Data from Clinical TrialsModels for Non-Normal Longitudinal Data from Clinical TrialsSurvival AnalysisBayesian Methods Longitudinal DataMeta-Analysis Readership: Applied statisticians in medicine, researchers dealing with clinical trials and pharmaceutical companies. Keywords:Clinical Trials;Longitudinal Data;Random Effects Models;Dropouts;Survival Analysis, Bayesian MethodsReviews:“… given a keen amateur interest and an ability to skip the occasional rather daunting-looking equation this book is surprisingly accessible … There's an introductory chapter containing an excellent historical overview.”Transactions of Royal Society of Tropical Medicine and Hygiene “In providing a concise description of the statistical aspects of the design and analysis of clinical trials, free of any major typographical errors, the authors have succeeded. Those concerned with the correct design and analysis of clinical trials, but wishing to avoid either the advanced theoretical aspects or too much focus on application of methodologies, will find this book to be very accessible with relatively up-to-date references.”Pharmaceutical Statistics
Book Synopsis Multiple Imputation and its Application by : James Carpenter
Download or read book Multiple Imputation and its Application written by James Carpenter and published by John Wiley & Sons. This book was released on 2012-12-21 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical guide to analysing partially observeddata. Collecting, analysing and drawing inferences from data iscentral to research in the medical and social sciences.Unfortunately, it is rarely possible to collect all the intendeddata. The literature on inference from the resultingincomplete data is now huge, and continues to grow both asmethods are developed for large and complex data structures, and asincreasing computer power and suitable software enable researchersto apply these methods. This book focuses on a particular statistical method foranalysing and drawing inferences from incomplete data, calledMultiple Imputation (MI). MI is attractive because it is bothpractical and widely applicable. The authors aim is to clarify theissues raised by missing data, describing the rationale for MI, therelationship between the various imputation models and associatedalgorithms and its application to increasingly complex datastructures. Multiple Imputation and its Application: Discusses the issues raised by the analysis of partiallyobserved data, and the assumptions on which analyses rest. Presents a practical guide to the issues to consider whenanalysing incomplete data from both observational studies andrandomized trials. Provides a detailed discussion of the practical use of MI withreal-world examples drawn from medical and social statistics. Explores handling non-linear relationships and interactionswith multiple imputation, survival analysis, multilevel multipleimputation, sensitivity analysis via multiple imputation, usingnon-response weights with multiple imputation and doubly robustmultiple imputation. Multiple Imputation and its Application is aimed atquantitative researchers and students in the medical and socialsciences with the aim of clarifying the issues raised by theanalysis of incomplete data data, outlining the rationale for MIand describing how to consider and address the issues that arise inits application.
Book Synopsis Clinical Trials Design in Operative and Non Operative Invasive Procedures by : Kamal M.F. Itani
Download or read book Clinical Trials Design in Operative and Non Operative Invasive Procedures written by Kamal M.F. Itani and published by Springer. This book was released on 2017-05-16 with total page 495 pages. Available in PDF, EPUB and Kindle. Book excerpt: The aim of this text is to provide the framework for building a clinical trial as it pertains to operative and non operative invasive procedures, how to get it funded and how to conduct such a trial up to publication of results The text provides all details of building a scientifically and ethically valid proposal, including how to build the infrastructure for a clinical trial and how to move it forward through various funding agencies. The text also presents various types of clinical trials, the use of implantable devices and FDA requirements, and adjuncts to clinical trials and interaction with industry Clinical Trials Design in Invasive Operative and Non Operative Procedures will be of interest to all specialists of surgery, anesthesiologists, interventional radiologists, gastroenterologists, cardiologists, and pulmonologists
