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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: 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: Craig H. Mallinckrodt Publisher: Cambridge University Press ISBN: 1107031389 Category : Mathematics Languages : en Pages : 185
Book Description
Focuses on the prevention and treatment of missing data in longitudinal clinical trials, looking at key principles and explaining analytic methods.
Author: Patrick E. McKnight Publisher: Guilford Press ISBN: 1606238205 Category : Social Science Languages : en Pages : 269
Book Description
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.
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: Steven Piantadosi Publisher: Springer Nature ISBN: 3319526367 Category : Medical Languages : en Pages : 2573
Book Description
This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.
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: 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: 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: Brian S Everitt Publisher: World Scientific ISBN: 1783260777 Category : Medical Languages : en Pages : 338
Book Description
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./a
Author: Bernard Ravina Publisher: Cambridge University Press ISBN: 1107376572 Category : Medical Languages : en Pages : 387
Book Description
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.
Author: National Research Council
Author: National Research Council
Author: Craig H. Mallinckrodt
Author: Patrick E. McKnight
Author: Michael O'Kelly
Author: Steven Piantadosi
Author: Geert Molenberghs
Author: Geert Molenberghs
Author: Stef van Buuren
Author: Brian S Everitt
Author: Bernard Ravina