sequential experimentation in clinical trials design and analysis 298 springer series in statistics

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Sequential Experimentation In Clinical Trials

Author : Jay Bartroff
ISBN : 9781461461142
Genre : Medical
File Size : 33. 73 MB
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Sequential Experimentation in Clinical Trials: Design and Analysis is developed from decades of work in research groups, statistical pedagogy, and workshop participation. Different parts of the book can be used for short courses on clinical trials, translational medical research, and sequential experimentation. The authors have successfully used the book to teach innovative clinical trial designs and statistical methods for Statistics Ph.D. students at Stanford University. There are additional online supplements for the book that include chapter-specific exercises and information. Sequential Experimentation in Clinical Trials: Design and Analysis covers the much broader subject of sequential experimentation that includes group sequential and adaptive designs of Phase II and III clinical trials, which have attracted much attention in the past three decades. In particular, the broad scope of design and analysis problems in sequential experimentation clearly requires a wide range of statistical methods and models from nonlinear regression analysis, experimental design, dynamic programming, survival analysis, resampling, and likelihood and Bayesian inference. The background material in these building blocks is summarized in Chapter 2 and Chapter 3 and certain sections in Chapter 6 and Chapter 7. Besides group sequential tests and adaptive designs, the book also introduces sequential change-point detection methods in Chapter 5 in connection with pharmacovigilance and public health surveillance. Together with dynamic programming and approximate dynamic programming in Chapter 3, the book therefore covers all basic topics for a graduate course in sequential analysis designs.

Optimal Design For Nonlinear Response Models

Author : Valerii V. Fedorov
ISBN : 9781439821510
Genre : Mathematics
File Size : 46. 69 MB
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Optimal Design for Nonlinear Response Models discusses the theory and applications of model-based experimental design with a strong emphasis on biopharmaceutical studies. The book draws on the authors’ many years of experience in academia and the pharmaceutical industry. While the focus is on nonlinear models, the book begins with an explanation of the key ideas, using linear models as examples. Applying the linearization in the parameter space, it then covers nonlinear models and locally optimal designs as well as minimax, optimal on average, and Bayesian designs. The authors also discuss adaptive designs, focusing on procedures with non-informative stopping. The common goals of experimental design—such as reducing costs, supporting efficient decision making, and gaining maximum information under various constraints—are often the same across diverse applied areas. Ethical and regulatory aspects play a much more prominent role in biological, medical, and pharmaceutical research. The authors address all of these issues through many examples in the book.

Group Sequential And Confirmatory Adaptive Designs In Clinical Trials

Author : Gernot Wassmer
ISBN : 9783319325620
Genre : Medical
File Size : 49. 7 MB
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This book provides an up-to-date review of the general principles of and techniques for confirmatory adaptive designs. Confirmatory adaptive designs are a generalization of group sequential designs. With these designs, interim analyses are performed in order to stop the trial prematurely under control of the Type I error rate. In adaptive designs, it is also permissible to perform a data-driven change of relevant aspects of the study design at interim stages. This includes, for example, a sample-size reassessment, a treatment-arm selection or a selection of a pre-specified sub-population. Essentially, this adaptive methodology was introduced in the 1990s. Since then, it has become popular and the object of intense discussion and still represents a rapidly growing field of statistical research. This book describes adaptive design methodology at an elementary level, while also considering designing and planning issues as well as methods for analyzing an adaptively planned trial. This includes estimation methods and methods for the determination of an overall p-value. Part I of the book provides the group sequential methods that are necessary for understanding and applying the adaptive design methodology supplied in Parts II and III of the book. The book contains many examples that illustrate use of the methods for practical application. The book is primarily written for applied statisticians from academia and industry who are interested in confirmatory adaptive designs. It is assumed that readers are familiar with the basic principles of descriptive statistics, parameter estimation and statistical testing. This book will also be suitable for an advanced statistical course for applied statisticians or clinicians with a sound statistical background.

Methods And Applications Of Statistics In The Life And Health Sciences

Author : N. Balakrishnan
ISBN : 9780470405093
Genre : Mathematics
File Size : 59. 44 MB
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"Data collection holds an essential part in dictating the future of health sciences and public health, as the compilation of statistics allows researchers and medical practitioners to monitor trends in health status, identify health problems, and evaluate the impact of health policies and programs. Methods and Applications of Statistics in the Life and Health Sciences serves as a single, one-of-a-kind resource on the wide range of statistical methods, techniques, and applications that are applied in modern life and health sciences in research. Specially designed to present encyclopedic content in an accessible and self-contained format, this book outlines thorough coverage of the underlying theory and standard applications to research in related disciplines such as biology, epidemiology, clinical trials, and public health. Uniquely combining established literature with cutting-edge research, this book contains classical works and more than twenty-five new articles and completely revised contributions from the acclaimed Encyclopedia of Statistical Sciences, Second Edition. The result is a compilation of more than eighty articles that explores classic methodology and new topics."--Publisher's description.

Proceedings Of The Ist World Congress Of The Bernoulli Society Mathematical Statistics Theory And Applications

Author : Bernoulli Society for Mathematical Statistics and Probability. World Congress
ISBN : 9067641057
Genre : Mathematical statistics
File Size : 36. 82 MB
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Probability Statistics And Modelling In Public Health

Author : M.S. Nikulin
ISBN : 9780387260235
Genre : Medical
File Size : 25. 90 MB
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Probability, Statistics and Modelling in Public Health consists of refereed contributions by expert biostatisticians that discuss various probabilistic and statistical models used in public health. Many of them are based on the work of Marvin Zelen of the Harvard School of Public Health. Topics discussed include models based on Markov and semi-Markov processes, multi-state models, models and methods in lifetime data analysis, accelerated failure models, design and analysis of clinical trials, Bayesian methods, pharmaceutical and environmental statistics, degradation models, epidemiological methods, screening programs, early detection of diseases, and measurement and analysis of quality of life.

Observational Studies

Author : Paul R. Rosenbaum
ISBN : 9781475724431
Genre : Mathematics
File Size : 39. 46 MB
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An observational study is an empirical investigation of the effects of treatments, policies, or exposures. It differes from an experiment in that the investigator cannot control the assignments of treatments to subjects. Scientists across a wide range of disciplines undertake such studies, and the aim of this book is to provide a sound statistical account of the principles and methods for the design and analysis of observational studies. Readers are assumed to have a working knowledge of basic probability and statistics, but otherwise the account is reasonably self-contained. Throughout there are extended discussions of actual observational studies to illustrate the ideas discussed. These are drawn from topics as diverse as smoking and lung cancer, lead in children, nuclear weapons testing, and placement programs for students. As a result, many researchers involved in observational studes will find this an invaluable companion to their work.

Statistica Sinica

Author :
ISBN : UOM:39015072605580
Genre : Mathematical statistics
File Size : 45. 16 MB
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Nonclinical Statistics For Pharmaceutical And Biotechnology Industries

Author : Lanju Zhang
ISBN : 9783319235585
Genre : Medical
File Size : 62. 55 MB
Format : PDF
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This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in these nonclinical areas. The chapters provide as appropriate, a scientific background to the topic, relevant regulatory guidance, current statistical practice, and further research directions.

Methods And Biostatistics In Oncology

Author : Raphael. L.C. Araújo
ISBN : 9783319713243
Genre : Medical
File Size : 74. 40 MB
Format : PDF
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This book introduces and discusses the most important aspects of clinical research methods and biostatistics for oncologists, pursuing a tailor-made and practical approach. Evidence-based medicine (EBM) has been in vogue in the last few decades, particularly in rapidly advancing fields such as oncology. This approach has been used to support decision-making processes worldwide, sparking new clinical research and guidelines on clinical and surgical oncology. Clinical oncology research has many peculiarities, including specific study endpoints, a special focus on survival analyses, and a unique perspective on EBM. However, during medical studies and in general practice, these topics are barely taught. Moreover, even when EBM and clinical cancer research are discussed, they are presented in a theoretical fashion, mostly focused on formulas and numbers, rather than on clinical application for a proper literature appraisal. Addressing that gap, this book discusses more practical aspects of clinical research and biostatistics in oncology, instead of relying only on mathematical formulas and theoretical considerations. Methods and Biostatistics in Oncology will help readers develop the skills they need to understand the use of research on everyday oncology clinical practice for study design and interpretation, as well to demystify the use of EBM in oncology.

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