Methods and Applications of Statistics in Clinical Trials, Volume 1
Methods and Applications of Statistics in Clinical Trials, Volume 1

Author: Narayanaswamy Balakrishnan

Publisher: John Wiley & Sons

Published: 2014-03-05

Total Pages: 937

ISBN-13: 1118595912

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A complete guide to the key statistical concepts essential for the design and construction of clinical trials As the newest major resource in the field of medical research, Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs presents a timely and authoritative reviewof the central statistical concepts used to build clinical trials that obtain the best results. The referenceunveils modern approaches vital to understanding, creating, and evaluating data obtained throughoutthe various stages of clinical trial design and analysis. Accessible and comprehensive, the first volume in a two-part set includes newly-written articles as well as established literature from the Wiley Encyclopedia of Clinical Trials. Illustrating a variety of statistical concepts and principles such as longitudinal data, missing data, covariates, biased-coin randomization, repeated measurements, and simple randomization, the book also provides in-depth coverage of the various trial designs found within phase I-IV trials. Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs also features: Detailed chapters on the type of trial designs, such as adaptive, crossover, group-randomized, multicenter, non-inferiority, non-randomized, open-labeled, preference, prevention, and superiority trials Over 100 contributions from leading academics, researchers, and practitioners An exploration of ongoing, cutting-edge clinical trials on early cancer and heart disease, mother-to-child human immunodeficiency virus transmission trials, and the AIDS Clinical Trials Group Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs is an excellent reference for researchers, practitioners, and students in the fields of clinicaltrials, pharmaceutics, biostatistics, medical research design, biology, biomedicine, epidemiology,and public health.

Medical Uses of Statistics, Second Edition
Medical Uses of Statistics, Second Edition

Author: Bailar/Mostelle

Publisher: CRC Press

Published: 1992-03-01

Total Pages: 488

ISBN-13: 9780910133364

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Explains the purpose of statistical methods in medical studies & analyzes the statistical techniques used by clinical investigators, with special emphasis on studies published in The New England Journal of Medicine. Clarifies fundamental concepts of statistical design & analysis & facilitates the understanding of research results.

Methods and Applications of Statistics in Clinical Trials, Volume 2
Methods and Applications of Statistics in Clinical Trials, Volume 2

Author: Narayanaswamy Balakrishnan

Publisher: John Wiley & Sons

Published: 2014-06-16

Total Pages: 953

ISBN-13: 1118595963

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Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods includes updates of established literature from the Wiley Encyclopedia of Clinical Trials as well as original material based on the latest developments in clinical trials. Prepared by a leading expert, the second volume includes numerous contributions from current prominent experts in the field of medical research. In addition, the volume features: • Multiple new articles exploring emerging topics, such as evaluation methods with threshold, empirical likelihood methods, nonparametric ROC analysis, over- and under-dispersed models, and multi-armed bandit problems • Up-to-date research on the Cox proportional hazard model, frailty models, trial reports, intrarater reliability, conditional power, and the kappa index • Key qualitative issues including cost-effectiveness analysis, publication bias, and regulatory issues, which are crucial to the planning and data management of clinical trials

Statistics Applied to Clinical Trials
Statistics Applied to Clinical Trials

Author: Ton J. Cleophas

Publisher: Springer Science & Business Media

Published: 2013-11-11

Total Pages: 105

ISBN-13: 9401595089

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In 1948 the first randomized controlled trial was published by the English Medical Research Council in the British Medical Journal. Until then, observations had been uncontrolled. Initially, trials frequently did not confirm the hypotheses to be tested. This phenomenon was attributed to low sensitivity due to small samples, as well as inappropriate hypotheses based on biased prior trials. Additional flaws were recognized and, subsequently, were better accounted for: carryover effects due to insufficient washout from previous treatments, time effects due to external factors and the natural history of the condition under study, bias due to asymmetry between treatment groups, lack of sensitivity due to a negative correlation between treatment responses, and so on. Such flaws, mainly of a technical nature, have been largely corrected and led to trials after 1970 being of significantly higher quality. The past decade has focused, in addition to technical aspects, on the need for circumspection in the planning and conducting of clinical trials. As a consequence, prior to approval, clinical trial protocols are now routinely scrutinized by different circumstantial organs, including ethics committees, institutional and federal review boards, national and international scientific organizations, and monitoring committees charged with conducting interim analyses. This book not only explains classical statistical analyses of clinical trials, but also addresses relatively novel issues, including equivalence testing, interim analyses, sequential analyses, and meta-analyses, and provides a framework of the best statistical methods currently available for such purposes. This book is not only useful for investigators involved in the field of clinical trials, but also for all physicians who wish to better understand the data of trials as currently published.

Essential Statistical Methods for Medical Statistics
Essential Statistical Methods for Medical Statistics

Author: J. Philip Miller

Publisher: Elsevier

Published: 2010-11-08

Total Pages: 363

ISBN-13: 0444537384

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Essential Statistical Methods for Medical Statistics presents only key contributions which have been selected from the volume in the Handbook of Statistics: Medical Statistics, Volume 27 (2009). While the use of statistics in these fields has a long and rich history, the explosive growth of science in general, and of clinical and epidemiological sciences in particular, has led to the development of new methods and innovative adaptations of standard methods. This volume is appropriately focused for individuals working in these fields. Contributors are internationally renowned experts in their respective areas. - Contributors are internationally renowned experts in their respective areas - Addresses emerging statistical challenges in epidemiological, biomedical, and pharmaceutical research - Methods for assessing Biomarkers, analysis of competing risks - Clinical trials including sequential and group sequential, crossover designs, cluster randomized, and adaptive designs - Structural equations modelling and longitudinal data analysis

Methods and Applications of Longitudinal Data Analysis
Methods and Applications of Longitudinal Data Analysis

Author: Xian Liu

Publisher: Elsevier

Published: 2015-09-01

Total Pages: 531

ISBN-13: 0128014822

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Methods and Applications of Longitudinal Data Analysis describes methods for the analysis of longitudinal data in the medical, biological and behavioral sciences. It introduces basic concepts and functions including a variety of regression models, and their practical applications across many areas of research. Statistical procedures featured within the text include: - descriptive methods for delineating trends over time - linear mixed regression models with both fixed and random effects - covariance pattern models on correlated errors - generalized estimating equations - nonlinear regression models for categorical repeated measurements - techniques for analyzing longitudinal data with non-ignorable missing observations Emphasis is given to applications of these methods, using substantial empirical illustrations, designed to help users of statistics better analyze and understand longitudinal data. Methods and Applications of Longitudinal Data Analysis equips both graduate students and professionals to confidently apply longitudinal data analysis to their particular discipline. It also provides a valuable reference source for applied statisticians, demographers and other quantitative methodologists. - From novice to professional: this book starts with the introduction of basic models and ends with the description of some of the most advanced models in longitudinal data analysis - Enables students to select the correct statistical methods to apply to their longitudinal data and avoid the pitfalls associated with incorrect selection - Identifies the limitations of classical repeated measures models and describes newly developed techniques, along with real-world examples.

Methods and Applications of Statistics in the Life and Health Sciences
Methods and Applications of Statistics in the Life and Health Sciences

Author: Narayanaswamy Balakrishnan

Publisher: John Wiley & Sons

Published: 2009-12-02

Total Pages: 1027

ISBN-13: 0470405090

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Inspired by the Encyclopedia of Statistical Sciences, Second Edition, this volume outlines the statistical tools for successfully working with modern life and health sciences research 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, including: Sequential methods in biomedical research Statistical measures of human quality of life Change-point methods in genetics Sample size determination for clinical trials Mixed-effects regression models for predicting pre-clinical disease Probabilistic and statistical models for conception Statistical methods are explored and applied to population growth, disease detection and treatment, genetic and genomic research, drug development, clinical trials, screening and prevention, and the assessment of rehabilitation, recovery, and quality of life. These topics are explored in contributions written by more than 100 leading academics, researchers, and practitioners who utilize various statistical practices, such as election bias, survival analysis, missing data techniques, and cluster analysis for handling the wide array of modern issues in the life and health sciences. With its combination of traditional methodology and newly developed research, Methods and Applications of Statistics in the Life and Health Sciences has everything students, academics, and researchers in the life and health sciences need to build and apply their knowledge of statistical methods and applications.

Introduction to Statistics in Pharmaceutical Clinical Trials
Introduction to Statistics in Pharmaceutical Clinical Trials

Author: Todd A. Durham

Publisher:

Published: 2008-01-01

Total Pages: 226

ISBN-13: 9780853697145

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All students of pharmaceutical sciences and clinical research need a solid knowledge and understanding of the nature, methods, application, and importance of statistics. Introduction to Statistics in Pharmaceutical Clinical Trials is an ideal introduction to statistics presented in the context of clinical trials conducted during pharmaceutical drug development. This novel approach both teaches the computational steps needed to conduct analyses and provides a conceptual understanding of how these analyses provide information that forms the rational basis for decision making throughout the drug development process.

Statistics in Clinical Vaccine Trials
Statistics in Clinical Vaccine Trials

Author: Jozef Nauta

Publisher: Springer Science & Business Media

Published: 2010-10-07

Total Pages: 165

ISBN-13: 3642146910

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This monograph offers well-founded training and expertise on the statistical analysis of data from clinical vaccine trials, i.e., immunogenicity and vaccine field efficacy studies. The book's scope is practical rather than theoretical. It opens with two introductory chapters on the immunology of vaccines to provide readers with the necessary background knowledge. It then continues with an in-depth exploration of the statistical methodology. Many real-life examples and SAS codes are presented, making application of the methods straightforward. Topics discussed include maximum likelihood estimation for censored antibody titers, ANCOVA for antibody values, analysis of equivalence and non-inferiority immunogenicity trial data, analysis of data from vaccine field efficacy trials (including data from studies with recurrent infection data), fitting protection curves to data of challenge or field efficacy studies, and the analysis of vaccine safety data.

Sequential Experimentation in Clinical Trials
Sequential Experimentation in Clinical Trials

Author: Jay Bartroff

Publisher: Springer Science & Business Media

Published: 2012-12-12

Total Pages: 250

ISBN-13: 1461461146

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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.