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Author: Geert Molenberghs Publisher: John Wiley & Sons ISBN: 9780470510438 Category : Medical Languages : en Pages : 526
Book Description
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.
Author: Geert Molenberghs Publisher: John Wiley & Sons ISBN: 9780470510438 Category : Medical Languages : en Pages : 526
Book Description
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.
Author: National Research Council Publisher: National Academies Press ISBN: 030918651X Category : Medical Languages : en Pages : 163
Book Description
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.
Author: Michael O'Kelly Publisher: John Wiley & Sons ISBN: 1118762533 Category : Medical Languages : en Pages : 472
Book Description
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.
Author: Michael J. Daniels Publisher: CRC Press ISBN: 9781420011180 Category : Mathematics Languages : en Pages : 328
Book Description
Drawing from the authors’ own work and from the most recent developments in the field, Missing Data in Longitudinal Studies: Strategies for Bayesian Modeling and Sensitivity Analysis describes a comprehensive Bayesian approach for drawing inference from incomplete data in longitudinal studies. To illustrate these methods, the authors employ several data sets throughout that cover a range of study designs, variable types, and missing data issues. The book first reviews modern approaches to formulate and interpret regression models for longitudinal data. It then discusses key ideas in Bayesian inference, including specifying prior distributions, computing posterior distribution, and assessing model fit. The book carefully describes the assumptions needed to make inferences about a full-data distribution from incompletely observed data. For settings with ignorable dropout, it emphasizes the importance of covariance models for inference about the mean while for nonignorable dropout, the book studies a variety of models in detail. It concludes with three case studies that highlight important features of the Bayesian approach for handling nonignorable missingness. With suggestions for further reading at the end of most chapters as well as many applications to the health sciences, this resource offers a unified Bayesian approach to handle missing data in longitudinal studies.
Author: Diane L. Fairclough Publisher: CRC Press ISBN: 1420061186 Category : Mathematics Languages : en Pages : 419
Book Description
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
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309316324 Category : Medical Languages : en Pages : 304
Book Description
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.
Author: Stef van Buuren Publisher: CRC Press ISBN: 0429960352 Category : Mathematics Languages : en Pages : 444
Book Description
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.
Author: Geert Molenberghs Publisher: CRC Press ISBN: 1439854610 Category : Mathematics Languages : en Pages : 600
Book Description
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.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309172802 Category : Medical Languages : en Pages : 88
Book Description
In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.
Author: Patricia Berglund Publisher: SAS Institute ISBN: 162959203X Category : Computers Languages : en Pages : 164
Book Description
Find guidance on using SAS for multiple imputation and solving common missing data issues. Multiple Imputation of Missing Data Using SAS provides both theoretical background and constructive solutions for those working with incomplete data sets in an engaging example-driven format. It offers practical instruction on the use of SAS for multiple imputation and provides numerous examples that use a variety of public release data sets with applications to survey data. Written for users with an intermediate background in SAS programming and statistics, this book is an excellent resource for anyone seeking guidance on multiple imputation. The authors cover the MI and MIANALYZE procedures in detail, along with other procedures used for analysis of complete data sets. They guide analysts through the multiple imputation process, including evaluation of missing data patterns, choice of an imputation method, execution of the process, and interpretation of results. Topics discussed include how to deal with missing data problems in a statistically appropriate manner, how to intelligently select an imputation method, how to incorporate the uncertainty introduced by the imputation process, and how to incorporate the complex sample design (if appropriate) through use of the SAS SURVEY procedures. Discover the theoretical background and see extensive applications of the multiple imputation process in action. This book is part of the SAS Press program.
Author: Geert Molenberghs
Author: Geert Molenberghs
Author: National Research Council
Author: Michael O'Kelly
Author: Michael J. Daniels
Author: Diane L. Fairclough
Author: Institute of Medicine
Author: Stef van Buuren
Author: Geert Molenberghs
Author: Institute of Medicine
Author: Patricia Berglund