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Medical Biostatistics Fourth Edition

Medical Biostatistics  Fourth Edition Author Abhaya Indrayan
ISBN-10 9781351585552
Release 2017-11-27
Pages 720
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Encyclopedic in breadth, yet practical and concise, Medical Biostatistics, Fourth Edition focuses on the statistical aspects ofmedicine with a medical perspective, showing the utility of biostatistics as a tool to manage many medical uncertainties. This edition includes more topics in order to fill gaps in the previous edition. Various topics have been enlarged and modified as per the new understanding of the subject.



Sample Size Calculations in Clinical Research Third Edition

Sample Size Calculations in Clinical Research  Third Edition Author Shein-Chung Chow
ISBN-10 9781351727112
Release 2017-08-15
Pages 510
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Praise for the Second Edition: "... this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics "This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered ..." – Journal of the Royal Statistical Society Sample Size Calculations in Clinical Research, Third Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. A comprehensive and unified presentation of statistical concepts and practical applications, this book includes a well-balanced summary of current and emerging clinical issues, regulatory requirements, and recently developed statistical methodologies for sample size calculation. Features: Compares the relative merits and disadvantages of statistical methods for sample size calculations Explains how the formulae and procedures for sample size calculations can be used in a variety of clinical research and development stages Presents real-world examples from several therapeutic areas, including cardiovascular medicine, the central nervous system, anti-infective medicine, oncology, and women’s health Provides sample size calculations for dose response studies, microarray studies, and Bayesian approaches This new edition is updated throughout, includes many new sections, and five new chapters on emerging topics: two stage seamless adaptive designs, cluster randomized trial design, zero-inflated Poisson distribution, clinical trials with extremely low incidence rates, and clinical trial simulation. ?



Design and Analysis of Clinical Trials

Design and Analysis of Clinical Trials Author Shein-Chung Chow
ISBN-10 9780471473299
Release 2008-12-04
Pages 752
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Design and Analysis of Clinical Trials has been writing in one form or another for most of life. You can find so many inspiration from Design and Analysis of Clinical Trials also informative, and entertaining. Click DOWNLOAD or Read Online button to get full Design and Analysis of Clinical Trials book for free.



Bayesian Methods in Health Economics

Bayesian Methods in Health Economics Author Gianluca Baio
ISBN-10 9781439895559
Release 2012-11-12
Pages 244
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Health economics is concerned with the study of the cost-effectiveness of health care interventions. This book provides an overview of Bayesian methods for the analysis of health economic data. After an introduction to the basic economic concepts and methods of evaluation, it presents Bayesian statistics using accessible mathematics. The next chapters describe the theory and practice of cost-effectiveness analysis from a statistical viewpoint, and Bayesian computation, notably MCMC. The final chapter presents three detailed case studies covering cost-effectiveness analyses using individual data from clinical trials, evidence synthesis and hierarchical models and Markov models. The text uses WinBUGS and JAGS with datasets and code available online.



Bayesian Missing Data Problems

Bayesian Missing Data Problems Author Ming T. Tan
ISBN-10 1420077503
Release 2009-08-26
Pages 344
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Bayesian Missing Data Problems: EM, Data Augmentation and Noniterative Computation presents solutions to missing data problems through explicit or noniterative sampling calculation of Bayesian posteriors. The methods are based on the inverse Bayes formulae discovered by one of the author in 1995. Applying the Bayesian approach to important real-world problems, the authors focus on exact numerical solutions, a conditional sampling approach via data augmentation, and a noniterative sampling approach via EM-type algorithms. After introducing the missing data problems, Bayesian approach, and posterior computation, the book succinctly describes EM-type algorithms, Monte Carlo simulation, numerical techniques, and optimization methods. It then gives exact posterior solutions for problems, such as nonresponses in surveys and cross-over trials with missing values. It also provides noniterative posterior sampling solutions for problems, such as contingency tables with supplemental margins, aggregated responses in surveys, zero-inflated Poisson, capture-recapture models, mixed effects models, right-censored regression model, and constrained parameter models. The text concludes with a discussion on compatibility, a fundamental issue in Bayesian inference. This book offers a unified treatment of an array of statistical problems that involve missing data and constrained parameters. It shows how Bayesian procedures can be useful in solving these problems.



Statistics In the Pharmaceutical Industry 3rd Edition

Statistics In the Pharmaceutical Industry  3rd Edition Author Charles Ralph Buncher
ISBN-10 0824790731
Release 1993-11-17
Pages 592
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This rewritten and updated second edition provides comprehensive information on the wide-ranging applications of statistics in the pharmacological field. Focusing on practical aspects, it sets out to bridge the gap between industry and academia.;Reflecting the changes that have taken place since publication of the first edition, this volume covers new topics such as: cancer clinical trials, clinical trials of AIDS patients and animal tumorigenicity studies; the development of antiepileptic drugs; the role of epidemiology in postmarketing trials and adverse drug experience; computer-assisted new drug application (CANDA) submissions; contract research organizations; interim analysis in clinical trials; and room-temperature tests for the stability of drugs.;This work is intended as: a reference for statisticians, biostatisticians, pharmacologists, administrators, managers, and scientists in the pharmaceutical industry; and a text for graduate students taking courses in applied statistics or pharmaceutical statistics.



Bayesian Methods in Epidemiology

Bayesian Methods in Epidemiology Author Lyle D. Broemeling
ISBN-10 9781466564978
Release 2013-08-13
Pages 464
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Written by a biostatistics expert with over 20 years of experience in the field, Bayesian Methods in Epidemiology presents statistical methods used in epidemiology from a Bayesian viewpoint. It employs the software package WinBUGS to carry out the analyses and offers the code in the text and for download online. The book examines study designs that investigate the association between exposure to risk factors and the occurrence of disease. It covers introductory adjustment techniques to compare mortality between states and regression methods to study the association between various risk factors and disease, including logistic regression, simple and multiple linear regression, categorical/ordinal regression, and nonlinear models. The text also introduces a Bayesian approach for the estimation of survival by life tables and illustrates other approaches to estimate survival, including a parametric model based on the Weibull distribution and the Cox proportional hazards (nonparametric) model. Using Bayesian methods to estimate the lead time of the modality, the author explains how to screen for a disease among individuals that do not exhibit any symptoms of the disease. With many examples and end-of-chapter exercises, this book is the first to introduce epidemiology from a Bayesian perspective. It shows epidemiologists how these Bayesian models and techniques are useful in studying the association between disease and exposure to risk factors.



Bioequivalence and Statistics in Clinical Pharmacology Second Edition

Bioequivalence and Statistics in Clinical Pharmacology  Second Edition Author Scott D. Patterson
ISBN-10 9781466585218
Release 2017-03-27
Pages 434
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Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrates the methods using real world examples. Drawing on knowledge gained directly from working in the pharmaceutical industry, the authors set the stage by describing the general role of statistics. Once the foundation of clinical pharmacology drug development, regulatory applications, and the design and analysis of bioequivalence trials are established,?including recent regulatory changes in design and analysis and in particular sample-size adaptation, they move on to related topics in clinical pharmacology involving the use of cross-over designs. These include, but are not limited to, safety studies in Phase I, dose-response trials, drug interaction trials, food-effect and combination trials, QTc and other pharmacodynamic equivalence trials, proof-of-concept trials, dose-proportionality trials, and vaccines trials.? This second edition addresses several recent developments in the field, including new chapters on adaptive bioequivalence studies, scaled average bioequivalence testing, and vaccine trials. Purposefully designed to be instantly applicable, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition provides examples of SAS and R code so that the analyses described can be immediately implemented. The authors have made extensive use of the proc mixed procedures available in SAS.



Basic Statistics and Pharmaceutical Statistical Applications

Basic Statistics and Pharmaceutical Statistical Applications Author James E. De Muth
ISBN-10 1420002902
Release 1999-06-18
Pages 624
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This extremely pragmatic and accessible reference provides scientists with a basic knowledge of statistics-focusing on the practical applications of statistical methods to research, quality control, and data analysis. Basic Statistics and Pharmaceutical Statistical Applications explores types of variables, random sampling, probability, measures of central tendency, and hypothesis (or significance) testing, discusses regression analysis, nonparametric tests, and power determination, and examines study designs, confidence intervals, dissolution testing, and bioequivalence. The author also describes the interrelation of hypotheses, test statistics, decision rules, computations, and statistical decisions and addresses testing factors such as precision, accuracy, bias, sensitivity, and selectivity Featuring almost 500 equations, tables, drawings, and references, Basic Statistics and Pharmaceutical Statistical Applications is required reading for pharmacists, analytical chemists, clinical trial monitors, medical writers, and upper-level undergraduate and graduate students in these disciplines.



Cluster Randomised Trials Second Edition

Cluster Randomised Trials  Second Edition Author Richard J. Hayes
ISBN-10 9781315353234
Release 2017-07-06
Pages 398
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Cluster Randomised Trials, Second Edition discusses the design, conduct, and analysis of trials that randomise groups of individuals to different treatments. It explores the advantages of cluster randomisation, with special attention given to evaluating the effects of interventions against infectious diseases. Avoiding unnecessary mathematical detail, the book covers basic concepts underlying the use of cluster randomisation, such as direct, indirect, and total effects. In the time since the publication of the first edition, the use of cluster randomised trials (CRTs) has increased substantially, which is reflected in the updates to this edition. There are greatly expanded sections on randomisation, sample size estimation, and alternative designs, including new material on stepped wedge designs. There is a new section on handling ordinal outcome data, and an appendix with descriptions and/or generating code of the example data sets. Although the book mainly focuses on medical and public health applications, it shows that the rigorous evidence of intervention effects provided by CRTs has the potential to inform public policy in a wide range of other areas. The book encourages readers to apply the methods to their own trials, reproduce the analyses presented, and explore alternative approaches.



Bayesian Analysis Made Simple

Bayesian Analysis Made Simple Author Phil Woodward
ISBN-10 9781439839553
Release 2016-04-19
Pages 364
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Although the popularity of the Bayesian approach to statistics has been growing for years, many still think of it as somewhat esoteric, not focused on practical issues, or generally too difficult to understand. Bayesian Analysis Made Simple is aimed at those who wish to apply Bayesian methods but either are not experts or do not have the time to create WinBUGS code and ancillary files for every analysis they undertake. Accessible to even those who would not routinely use Excel, this book provides a custom-made Excel GUI, immediately useful to those users who want to be able to quickly apply Bayesian methods without being distracted by computing or mathematical issues. From simple NLMs to complex GLMMs and beyond, Bayesian Analysis Made Simple describes how to use Excel for a vast range of Bayesian models in an intuitive manner accessible to the statistically savvy user. Packed with relevant case studies, this book is for any data analyst wishing to apply Bayesian methods to analyze their data, from professional statisticians to statistically aware scientists.



Statistical Design and Analysis of Clinical Trials

Statistical Design and Analysis of Clinical Trials Author Weichung Joe Shih
ISBN-10 1482250497
Release 2015-08-27
Pages 242
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This text is designed for second- and third-year graduate students in public health settings. Organized based on a 15-week course, the book provides lecture material and in-class exercises and homework problems in each chapter. The text balances the coverage of concepts and methods to suit students in biostatistics, clinical epidemiology, and health systems and policy.



Joint Models for Longitudinal and Time to Event Data

Joint Models for Longitudinal and Time to Event Data Author Dimitris Rizopoulos
ISBN-10 9781439872864
Release 2012-06-22
Pages 275
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In longitudinal studies it is often of interest to investigate how a marker that is repeatedly measured in time is associated with a time to an event of interest, e.g., prostate cancer studies where longitudinal PSA level measurements are collected in conjunction with the time-to-recurrence. Joint Models for Longitudinal and Time-to-Event Data: With Applications in R provides a full treatment of random effects joint models for longitudinal and time-to-event outcomes that can be utilized to analyze such data. The content is primarily explanatory, focusing on applications of joint modeling, but sufficient mathematical details are provided to facilitate understanding of the key features of these models. All illustrations put forward can be implemented in the R programming language via the freely available package JM written by the author. All the R code used in the book is available at: http://jmr.r-forge.r-project.org/



Clinical Trials in Oncology Third Edition

Clinical Trials in Oncology  Third Edition Author Stephanie Green
ISBN-10 9781439814482
Release 2012-05-09
Pages 264
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The third edition of the bestselling Clinical Trials in Oncology provides a concise, nontechnical, and thoroughly up-to-date review of methods and issues related to cancer clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the pitfalls inherent in these processes. In addition, the book has been restructured to have separate chapters and expanded discussions on general clinical trials issues, and issues specific to Phases I, II, and III. New sections cover innovations in Phase I designs, randomized Phase II designs, and overcoming the challenges of array data. Although this book focuses on cancer trials, the same issues and concepts are important in any clinical setting. As always, the authors use clear, lucid prose and a multitude of real-world examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Armed with Clinical Trials in Oncology, Third Edition, clinicians and statisticians can avoid the many hazards that can jeopardize the success of a trial.



Bayesian Designs for Phase I II Clinical Trials

Bayesian Designs for Phase I   II Clinical Trials Author Ying Yuan
ISBN-10 9781498709569
Release 2016-06-08
Pages 310
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Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials. At the same time, if promising preclinical results do not translate into a real treatment advance, it is important to determine this quickly and terminate the clinical evaluation process to avoid wasting resources. Bayesian Designs for Phase I–II Clinical Trials describes how phase I–II designs can serve as a bridge or protective barrier between preclinical studies and large confirmatory clinical trials. It illustrates many of the severe drawbacks with conventional methods used for early-phase clinical trials and presents numerous Bayesian designs for human clinical trials of new experimental treatment regimes. The first two chapters minimize the technical language to make them accessible to non-statisticians. These chapters discuss the severe drawbacks of the conventional paradigm used for early-phase clinical trials and explain the phase I–II paradigm for optimizing dose, or more general treatment regimes, based on both efficacy and toxicity. The remainder of the book covers a wide variety of clinical trial methodologies, including designs to optimize the dose pair of a two-drug combination, jointly optimize dose and schedule, identify optimal personalized doses, optimize novel molecularly targeted agents, and choose doses in two treatment cycles. Written by research leaders from the University of Texas MD Anderson Cancer Center, this book shows how Bayesian designs for early-phase clinical trials can explore, refine, and optimize new experimental treatments. It emphasizes the importance of basing decisions on both efficacy and toxicity.



Self Controlled Case Series Studies

Self Controlled Case Series Studies Author Paddy Farrington
ISBN-10 9780429957529
Release 2018-05-03
Pages 362
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"The self-controlled case series has emerged as a key methodology for studying the effects of healthcare interventions. The overall literature around the self-controlled case series has exploded in recent years and this important and timely book pulls it all together in an effective and clear manner. It certainly belongs on the shelf (or beside the keyboard) of every analyst conducting observational studies in healthcare." —David Madigan, Columbia University Self-Controlled Case Series Studies: A Modelling Guide with R provides the first comprehensive account of the self-controlled case series (SCCS) method, a statistical technique for investigating associations between outcome events and time-varying exposures. The method only requires information from individuals who have experienced the event of interest, and automatically controls for multiplicative time-invariant confounders, even when these are unmeasured or unknown. It is increasingly being used in epidemiology, most frequently to study the safety of vaccines and pharmaceutical drugs. Key features of the book include: A thorough yet accessible description of the SCCS method, with mathematical details provided in separate starred sections. Comprehensive discussion of assumptions and how they may be verified. A detailed account of different SCCS models, extensions of the SCCS method, and the design of SCCS studies. Extensive practical illustrations and worked examples from epidemiology. Full computer code from the associated R package SCCS, which includes all the data sets used in the book. The book is aimed at a broad range of readers, including epidemiologists and medical statisticians who wish to use the SCCS method, and also researchers with an interest in statistical methodology. The three authors have been closely involved with the inception, development, popularisation and programming of the SCCS method.



Cancer Clinical Trials

Cancer Clinical Trials Author Stephen L. George
ISBN-10 9781498706902
Release 2016-08-19
Pages 474
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Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. Well-known statisticians from academic institutions, regulatory and government agencies (such as the U.S. FDA and National Cancer Institute), and the pharmaceutical industry share their extensive experiences in cancer clinical trials and present examples taken from actual trials. The book covers topics that are often perplexing and sometimes controversial in cancer clinical trials. Most of the issues addressed are also important for clinical trials in other settings. After discussing general topics, the book focuses on aspects of early and late phase clinical trials. It also explores personalized medicine, including biomarker-based clinical trials, adaptive clinical trial designs, and dynamic treatment regimes.