Missing Data In Clinical Studies

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Missing Data in Clinical Studies

Geert Molenberghs,Michael Kenward
Missing Data in Clinical Studies Book PDF

Author : Geert Molenberghs,Michael Kenward
Publisher : John Wiley & Sons
Page : 526 pages
File Size : 43,7 Mb
Release : 2007-04-04
Category : Medical
ISBN : 0470510439

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Missing Data in Clinical Studies by Geert Molenberghs,Michael Kenward Pdf

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.

The Prevention and Treatment of Missing Data in Clinical Trials

National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials
The Prevention and Treatment of Missing Data in Clinical Trials Book PDF

Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials
Publisher : National Academies Press
Page : 163 pages
File Size : 55,9 Mb
Release : 2010-12-21
Category : Medical
ISBN : 9780309186513

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The Prevention and Treatment of Missing Data in Clinical Trials by National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials Pdf

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.

Clinical Trials with Missing Data

Michael O'Kelly,Bohdana Ratitch
Clinical Trials with Missing Data Book PDF

Author : Michael O'Kelly,Bohdana Ratitch
Publisher : John Wiley & Sons
Page : 472 pages
File Size : 42,8 Mb
Release : 2014-04-07
Category : Medical
ISBN : 9781118460702

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Clinical Trials with Missing Data by Michael O'Kelly,Bohdana Ratitch Pdf

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.

The Prevention and Treatment of Missing Data in Clinical Trials

National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials
The Prevention and Treatment of Missing Data in Clinical Trials Book PDF

Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials
Publisher : National Academies Press
Page : 162 pages
File Size : 50,5 Mb
Release : 2011-01-21
Category : Medical
ISBN : 9780309158145

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The Prevention and Treatment of Missing Data in Clinical Trials by National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials Pdf

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.

Sharing Clinical Trial Data

Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data
Sharing Clinical Trial Data Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data
Publisher : National Academies Press
Page : 304 pages
File Size : 51,6 Mb
Release : 2015-04-20
Category : Medical
ISBN : 9780309316323

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Sharing Clinical Trial Data by Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data Pdf

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.

Missing Data in Longitudinal Studies

Michael J. Daniels,Joseph W. Hogan
Missing Data in Longitudinal Studies Book PDF

Author : Michael J. Daniels,Joseph W. Hogan
Publisher : CRC Press
Page : 324 pages
File Size : 51,9 Mb
Release : 2008-03-11
Category : Mathematics
ISBN : 9781420011180

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Missing Data in Longitudinal Studies by Michael J. Daniels,Joseph W. Hogan Pdf

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

Design and Analysis of Quality of Life Studies in Clinical Trials

Diane L. Fairclough
Design and Analysis of Quality of Life Studies in Clinical Trials Book PDF

Author : Diane L. Fairclough
Publisher : CRC Press
Page : 419 pages
File Size : 41,7 Mb
Release : 2010-01-07
Category : Mathematics
ISBN : 9781420061185

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Design and Analysis of Quality of Life Studies in Clinical Trials by Diane L. Fairclough Pdf

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

Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making

Institute of Medicine,Roundtable on Research and Development of Drugs, Biologics, and Medical Devices
Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making Book PDF

Author : Institute of Medicine,Roundtable on Research and Development of Drugs, Biologics, and Medical Devices
Publisher : National Academies Press
Page : 88 pages
File Size : 48,9 Mb
Release : 1999-07-27
Category : Medical
ISBN : 9780309172806

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Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making by Institute of Medicine,Roundtable on Research and Development of Drugs, Biologics, and Medical Devices Pdf

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.

Applied Longitudinal Data Analysis for Epidemiology

Jos W. R. Twisk
Applied Longitudinal Data Analysis for Epidemiology Book PDF

Author : Jos W. R. Twisk
Publisher : Cambridge University Press
Page : 337 pages
File Size : 44,5 Mb
Release : 2013-05-09
Category : Medical
ISBN : 9781107030039

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Applied Longitudinal Data Analysis for Epidemiology by Jos W. R. Twisk Pdf

A practical guide to the most important techniques available for longitudinal data analysis, essential for non-statisticians and researchers.

Flexible Imputation of Missing Data, Second Edition

Stef van Buuren
Flexible Imputation of Missing Data Second Edition Book PDF

Author : Stef van Buuren
Publisher : CRC Press
Page : 444 pages
File Size : 47,6 Mb
Release : 2018-07-17
Category : Mathematics
ISBN : 9780429960352

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Flexible Imputation of Missing Data, Second Edition by Stef van Buuren Pdf

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.

Multiple Imputation and its Application

James Carpenter,Michael Kenward
Multiple Imputation and its Application Book PDF

Author : James Carpenter,Michael Kenward
Publisher : John Wiley & Sons
Page : 368 pages
File Size : 49,9 Mb
Release : 2012-12-21
Category : Medical
ISBN : 9781119942276

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Multiple Imputation and its Application by James Carpenter,Michael Kenward Pdf

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.

Estimands, Estimators and Sensitivity Analysis in Clinical Trials

Craig Mallinckrodt,Geert Molenberghs,Ilya Lipkovich,Bohdana Ratitch
Estimands Estimators and Sensitivity Analysis in Clinical Trials Book PDF

Author : Craig Mallinckrodt,Geert Molenberghs,Ilya Lipkovich,Bohdana Ratitch
Publisher : CRC Press
Page : 345 pages
File Size : 50,9 Mb
Release : 2019-12-23
Category : Medical
ISBN : 9780429950063

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Estimands, Estimators and Sensitivity Analysis in Clinical Trials by Craig Mallinckrodt,Geert Molenberghs,Ilya Lipkovich,Bohdana Ratitch Pdf

The concepts of estimands, analyses (estimators), and sensitivity are interrelated. Therefore, great need exists for an integrated approach to these topics. This book acts as a practical guide to developing and implementing statistical analysis plans by explaining fundamental concepts using accessible language, providing technical details, real-world examples, and SAS and R code to implement analyses. The updated ICH guideline raises new analytic and cross-functional challenges for statisticians. Gaps between different communities have come to surface, such as between causal inference and clinical trialists, as well as among clinicians, statisticians, and regulators when it comes to communicating decision-making objectives, assumptions, and interpretations of evidence. This book lays out a path toward bridging some of these gaps. It offers A common language and unifying framework along with the technical details and practical guidance to help statisticians meet the challenges A thorough treatment of intercurrent events (ICEs), i.e., postrandomization events that confound interpretation of outcomes and five strategies for ICEs in ICH E9 (R1) Details on how estimands, integrated into a principled study development process, lay a foundation for coherent specification of trial design, conduct, and analysis needed to overcome the issues caused by ICEs: A perspective on the role of the intention-to-treat principle Examples and case studies from various areas Example code in SAS and R A connection with causal inference Implications and methods for analysis of longitudinal trials with missing data Together, the authors have offered the readers their ample expertise in clinical trial design and analysis, from an industrial and academic perspective.

Multiple Imputation of Missing Data Using SAS

Patricia Berglund,Steven G. Heeringa
Multiple Imputation of Missing Data Using SAS Book PDF

Author : Patricia Berglund,Steven G. Heeringa
Publisher : SAS Institute
Page : 164 pages
File Size : 49,5 Mb
Release : 2014-07-01
Category : Computers
ISBN : 9781629592039

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Multiple Imputation of Missing Data Using SAS by Patricia Berglund,Steven G. Heeringa Pdf

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.

Preventing and Treating Missing Data in Longitudinal Clinical Trials

Craig H. Mallinckrodt
Preventing and Treating Missing Data in Longitudinal Clinical Trials Book PDF

Author : Craig H. Mallinckrodt
Publisher : Cambridge University Press
Page : 185 pages
File Size : 53,5 Mb
Release : 2013-01-28
Category : Mathematics
ISBN : 9781107031388

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Preventing and Treating Missing Data in Longitudinal Clinical Trials by Craig H. Mallinckrodt Pdf

Focuses on the prevention and treatment of missing data in longitudinal clinical trials, looking at key principles and explaining analytic methods.

Analysis of Incomplete Multivariate Data

J.L. Schafer
Analysis of Incomplete Multivariate Data Book PDF

Author : J.L. Schafer
Publisher : CRC Press
Page : 478 pages
File Size : 52,7 Mb
Release : 1997-08-01
Category : Mathematics
ISBN : 1439821860

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Analysis of Incomplete Multivariate Data by J.L. Schafer Pdf

The last two decades have seen enormous developments in statistical methods for incomplete data. The EM algorithm and its extensions, multiple imputation, and Markov Chain Monte Carlo provide a set of flexible and reliable tools from inference in large classes of missing-data problems. Yet, in practical terms, those developments have had surprisingly little impact on the way most data analysts handle missing values on a routine basis. Analysis of Incomplete Multivariate Data helps bridge the gap between theory and practice, making these missing-data tools accessible to a broad audience. It presents a unified, Bayesian approach to the analysis of incomplete multivariate data, covering datasets in which the variables are continuous, categorical, or both. The focus is applied, where necessary, to help readers thoroughly understand the statistical properties of those methods, and the behavior of the accompanying algorithms. All techniques are illustrated with real data examples, with extended discussion and practical advice. All of the algorithms described in this book have been implemented by the author for general use in the statistical languages S and S Plus. The software is available free of charge on the Internet.