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Medical Biostatistics Third Edition

Medical Biostatistics  Third Edition Author Abhaya Indrayan
ISBN-10 9781439884140
Release 2012-08-07
Pages 1024
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Encyclopedic in breadth, yet practical and concise, Medical Biostatistics, Third Edition focuses on the statistical aspects of medicine with a medical perspective, showing the utility of biostatistics as a tool to manage many medical uncertainties. The author concludes "Just as results of medical tests, statistical results can be false negative or false positive". This edition provides expanded coverage of topics and includes software illustrations. The author presents step-by-step explanations of statistical methods with the help of numerous real-world examples. Guide charts at the beginning of the book enable quick access to the relevant statistical procedure, and the comprehensive index makes it easier to locate terms of interest.



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.



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 Adaptive Methods for Clinical Trials

Bayesian Adaptive Methods for Clinical Trials Author Scott M. Berry
ISBN-10 1439825513
Release 2010-07-19
Pages 323
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Already popular in the analysis of medical device trials, adaptive Bayesian designs are increasingly being used in drug development for a wide variety of diseases and conditions, from Alzheimer’s disease and multiple sclerosis to obesity, diabetes, hepatitis C, and HIV. Written by leading pioneers of Bayesian clinical trial designs, Bayesian Adaptive Methods for Clinical Trials explores the growing role of Bayesian thinking in the rapidly changing world of clinical trial analysis. The book first summarizes the current state of clinical trial design and analysis and introduces the main ideas and potential benefits of a Bayesian alternative. It then gives an overview of basic Bayesian methodological and computational tools needed for Bayesian clinical trials. With a focus on Bayesian designs that achieve good power and Type I error, the next chapters present Bayesian tools useful in early (Phase I) and middle (Phase II) clinical trials as well as two recent Bayesian adaptive Phase II studies: the BATTLE and ISPY-2 trials. In the following chapter on late (Phase III) studies, the authors emphasize modern adaptive methods and seamless Phase II–III trials for maximizing information usage and minimizing trial duration. They also describe a case study of a recently approved medical device to treat atrial fibrillation. The concluding chapter covers key special topics, such as the proper use of historical data, equivalence studies, and subgroup analysis. For readers involved in clinical trials research, this book significantly updates and expands their statistical toolkits. The authors provide many detailed examples drawing on real data sets. The R and WinBUGS codes used throughout are available on supporting websites. Scott Berry talks about the book on the CRC Press YouTube Channel.



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.



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.



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/



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.



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.



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.



Applied Surrogate Endpoint Evaluation Methods with SAS and R

Applied Surrogate Endpoint Evaluation Methods with SAS and R Author Ariel Alonso
ISBN-10 9781482249378
Release 2016-11-30
Pages 396
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An important factor that affects the duration, complexity and cost of a clinical trial is the endpoint used to study the treatment’s efficacy. When a true endpoint is difficult to use because of such factors as long follow-up times or prohibitive cost, it is sometimes possible to use a surrogate endpoint that can be measured in a more convenient or cost-effective way. This book focuses on the use of surrogate endpoint evaluation methods in practice, using SAS and R.



Randomization Masking and Allocation Concealment

Randomization  Masking  and Allocation Concealment Author Vance Berger
ISBN-10 9781315305103
Release 2017-10-30
Pages 251
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Randomization, Masking, and Allocation Concealment is indispensable for any trial researcher who wants to use state of the art randomization methods, and also wants to be able to describe these methods correctly. Far too often the subtle nuances that distinguish proper randomization from flawed randomization are completely ignored in trial reports that state only that randomization was used, with no additional information. Experience has shown that in many cases, the type of randomization that was used was flawed. It is only a matter of time before medical journals and regulatory agencies come to realize that we can no longer rely on (or publish) flawed trials, and that flawed randomization in and of itself disqualifies a trial from being robust or high quality, even if that trial is of high quality otherwise. This book will help to clarify the role randomization plays in ensuring internal validity, and in drawing valid inferences from the data. The various chapters cover a variety of randomization methods, and are not limited to the most common (and most flawed) ones. Readers will come away with a profound understanding of what constitutes a valid randomization procedure, so that they can distinguish the valid from the flawed among not only existing methods but also methods yet to be developed.



Cluster Randomised Trials Second Edition

Cluster Randomised Trials  Second Edition Author Richard J. Hayes
ISBN-10 1498728227
Release 2017
Pages 400
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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.



Modern Adaptive Randomized Clinical Trials

Modern Adaptive Randomized Clinical Trials Author Oleksandr Sverdlov
ISBN-10 9781482239898
Release 2015-06-30
Pages 533
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Is adaptive randomization always better than traditional fixed-schedule randomization? Which procedures should be used and under which circumstances? What special considerations are required for adaptive randomized trials? What kind of statistical inference should be used to achieve valid and unbiased treatment comparisons following adaptive randomization designs? Modern Adaptive Randomized Clinical Trials: Statistical and Practical Aspects answers these questions and more. From novel designs to cutting-edge applications, this book presents several new and key developments in adaptive randomization. It also offers a fresh and critical look at a number of already-classical topics. Featuring contributions from statisticians, clinical trialists, and subject-matter experts in academia and the pharmaceutical industry, the text: Clarifies the taxonomy of the concept of adaptive randomization Discusses restricted, covariate-adaptive, response-adaptive, and covariate-adjusted response-adaptive (CARA) randomization designs, as well as randomized designs with treatment selection Gives an exposition to many novel adaptive randomization techniques such as brick tunnel randomization, targeted least absolute shrinkage and selection operator (LASSO)-based CARA randomization, multi-arm multi-stage (MAMS) designs, to name a few Addresses the issues of statistical inference following covariate-adaptive and response-adaptive randomization designs Describes a successful implementation of a single pivotal phase II/III adaptive trial in infants with proliferating hemangioma Explores some practical aspects of phase II dose-ranging studies and examines statistical monitoring and interim analysis issues in response-adaptive randomized clinical trials Modern Adaptive Randomized Clinical Trials: Statistical and Practical Aspects covers a wide spectrum of topics related to adaptive randomization designs in contemporary clinical trials. The book provides a thorough exploration of the merits of adaptive randomization and aids in identifying when it is appropriate to apply such designs in practice.



Statistics in the pharmaceutical industry

Statistics in the pharmaceutical industry Author Charles Ralph Buncher
ISBN-10 0824711637
Release 1981
Pages 465
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Statistics in the pharmaceutical industry has been writing in one form or another for most of life. You can find so many inspiration from Statistics in the pharmaceutical industry also informative, and entertaining. Click DOWNLOAD or Read Online button to get full Statistics in the pharmaceutical industry book for free.