Applied Statistics In Biomedicine And Clinical Trials Design

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Applied Statistics in Biomedicine and Clinical Trials Design

Author : Zhen Chen
Publisher : Springer
ISBN 13 : 3319126946
Total Pages : 550 pages
Book Rating : 4.3/5 (191 download)

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Book Synopsis Applied Statistics in Biomedicine and Clinical Trials Design by : Zhen Chen

Download or read book Applied Statistics in Biomedicine and Clinical Trials Design written by Zhen Chen and published by Springer. This book was released on 2015-05-04 with total page 550 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume is a unique combination of papers that cover critical topics in biostatistics from academic, government, and industry perspectives. The 6 sections cover Bayesian methods in biomedical research; Diagnostic medicine and classification; Innovative Clinical Trials Design; Modelling and Data Analysis; Personalized Medicine; and Statistical Genomics. The real world applications are in clinical trials, diagnostic medicine and genetics. The peer-reviewed contributions were solicited and selected from some 400 presentations at the annual meeting of the International Chinese Statistical Association (ICSA), held with the International Society for Biopharmaceutical Statistics (ISBS). The conference was held in Bethesda in June 2013, and the material has been subsequently edited and expanded to cover the most recent developments.

Biopharmaceutical Applied Statistics Symposium

Author : Karl E. Peace
Publisher : Springer
ISBN 13 : 9811078297
Total Pages : 414 pages
Book Rating : 4.8/5 (11 download)

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Book Synopsis Biopharmaceutical Applied Statistics Symposium by : Karl E. Peace

Download or read book Biopharmaceutical Applied Statistics Symposium written by Karl E. Peace and published by Springer. This book was released on 2018-08-20 with total page 414 pages. Available in PDF, EPUB and Kindle. Book excerpt: This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments – particularly biopharmaceutical clinical trials. The papers were selected from invited presentations at the Biopharmaceutical Applied Statistics Symposium (BASS), which was founded by the first Editor in 1994 and has since become the premier international conference in biopharmaceutical statistics. The primary aims of the BASS are: 1) to raise funding to support graduate students in biostatistics programs, and 2) to provide an opportunity for professionals engaged in pharmaceutical drug research and development to share insights into solving the problems they encounter.The BASS book series is initially divided into three volumes addressing: 1) Design of Clinical Trials; 2) Biostatistical Analysis of Clinical Trials; and 3) Pharmaceutical Applications. This book is the first of the 3-volume book series. The topics covered include: A Statistical Approach to Clinical Trial Simulations, Comparison of Statistical Analysis Methods Using Modeling and Simulation for Optimal Protocol Design, Adaptive Trial Design in Clinical Research, Best Practices and Recommendations for Trial Simulations in the Context of Designing Adaptive Clinical Trials, Designing and Analyzing Recurrent Event Data Trials, Bayesian Methodologies for Response-Adaptive Allocation, Addressing High Placebo Response in Neuroscience Clinical Trials, Phase I Cancer Clinical Trial Design: Single and Combination Agents, Sample Size and Power for the Mixed Linear Model, Crossover Designs in Clinical Trials, Data Monitoring: Structure for Clinical Trials and Sequential Monitoring Procedures, Design and Data Analysis for Multiregional Clinical Trials – Theory and Practice, Adaptive Group-Sequential Multi-regional Outcome Studies in Vaccines, Development and Validation of Patient-reported Outcomes, Interim Analysis of Survival Trials: Group Sequential Analyses, and Conditional Power – A Non-proportional Hazards Perspective.

Biopharmaceutical Applied Statistics Symposium

Author : Karl E. Peace
Publisher :
ISBN 13 : 9789811078309
Total Pages : pages
Book Rating : 4.0/5 (783 download)

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Book Synopsis Biopharmaceutical Applied Statistics Symposium by : Karl E. Peace

Download or read book Biopharmaceutical Applied Statistics Symposium written by Karl E. Peace and published by . This book was released on 2018 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments - particularly biopharmaceutical clinical trials. The papers were selected from invited presentations at the Biopharmaceutical Applied Statistics Symposium (BASS), which was founded by the first Editor in 1994 and has since become the premier international conference in biopharmaceutical statistics. The primary aims of the BASS are: 1) to raise funding to support graduate students in biostatistics programs, and 2) to provide an opportunity for professionals engaged in pharmaceutical drug research and development to share insights into solving the problems they encounter. The BASS book series is initially divided into three volumes addressing: 1) Design of Clinical Trials; 2) Biostatistical Analysis of Clinical Trials; and 3) Pharmaceutical Applications. This book is the first of the 3-vol ume book series. The topics covered include: A Statistical Approach to Clinical Trial Simulations, Comparison of Statistical Analysis Methods Using Modeling and Simulation for Optimal Protocol Design, Adaptive Trial Design in Clinical Research, Best Practices and Recommendations for Trial Simulations in the Context of Designing Adaptive Clinical Trials, Designing and Analyzing Recurrent Event Data Trials, Bayesian Methodologies for Response-Adaptive Allocation, Addressing High Placebo Response in Neuroscience Clinical Trials, Phase I Cancer Clinical Trial Design: Single and Combination Agents, Sample Size and Power for the Mixed Linear Model, Crossover Designs in Clinical Trials, Data Monitoring: Structure for Clinical Trials and Sequential Monitoring Procedures, Design and Data Analysis for Multiregional Clinical Trials - Theory and Practice, Adaptive Group-Sequential Multi-regional Outcome Studies in Vaccines, Development and Validation of Patient-reported Outcomes, Interim Analysis of Survival Trials: Group Sequential Analyses, and Conditional Power - A Non-proportional Hazards Perspective.--

Methods and Applications of Statistics in Clinical Trials, Volume 1

Author : Narayanaswamy Balakrishnan
Publisher : John Wiley & Sons
ISBN 13 : 1118595912
Total Pages : 937 pages
Book Rating : 4.1/5 (185 download)

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Book Synopsis Methods and Applications of Statistics in Clinical Trials, Volume 1 by : Narayanaswamy Balakrishnan

Download or read book Methods and Applications of Statistics in Clinical Trials, Volume 1 written by Narayanaswamy Balakrishnan and published by John Wiley & Sons. This book was released on 2014-03-05 with total page 937 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Statistical Applications from Clinical Trials and Personalized Medicine to Finance and Business Analytics

Author : Jianchang Lin
Publisher : Springer
ISBN 13 : 3319425684
Total Pages : 351 pages
Book Rating : 4.3/5 (194 download)

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Book Synopsis Statistical Applications from Clinical Trials and Personalized Medicine to Finance and Business Analytics by : Jianchang Lin

Download or read book Statistical Applications from Clinical Trials and Personalized Medicine to Finance and Business Analytics written by Jianchang Lin and published by Springer. This book was released on 2016-11-13 with total page 351 pages. Available in PDF, EPUB and Kindle. Book excerpt: The papers in this volume represent a broad, applied swath of advanced contributions to the 2015 ICSA/Graybill Applied Statistics Symposium of the International Chinese Statistical Association, held at Colorado State University in Fort Collins. The contributions cover topics that range from statistical applications in business and finance to applications in clinical trials and biomarker analysis. Each papers was peer-reviewed by at least two referees and also by an editor. The conference was attended by over 400 participants from academia, industry, and government agencies around the world, including from North America, Asia, and Europe.

Biopharmaceutical Applied Statistics Symposium

Author : Karl E. Peace
Publisher : Springer
ISBN 13 : 9811078262
Total Pages : 251 pages
Book Rating : 4.8/5 (11 download)

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Book Synopsis Biopharmaceutical Applied Statistics Symposium by : Karl E. Peace

Download or read book Biopharmaceutical Applied Statistics Symposium written by Karl E. Peace and published by Springer. This book was released on 2018-08-21 with total page 251 pages. Available in PDF, EPUB and Kindle. Book excerpt: This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments – particularly biopharmaceutical clinical trials. The papers were selected from invited presentations at the Biopharmaceutical Applied Statistics Symposium (BASS), which was founded by the first Editor in 1994 and has since become the premier international conference in biopharmaceutical statistics. The primary aims of the BASS are: 1) to raise funding to support graduate students in biostatistics programs, and 2) to provide an opportunity for professionals engaged in pharmaceutical drug research and development to share insights into solving the problems they encounter. The BASS book series is initially divided into three volumes addressing: 1) Design of Clinical Trials; 2) Biostatistical Analysis of Clinical Trials; and 3) Pharmaceutical Applications. This book is the second of the 3-volume book series. The topics covered include: Statistical Approaches to the Meta-analysis of Randomized Clinical Trials, Collaborative Targeted Maximum Likelihood Estimation to Assess Causal Effects in Observational Studies, Generalized Tests in Clinical Trials, Discrete Time-to-event and Score-based Methods with Application to Composite Endpoint for Assessing Evidence of Disease Activity-Free , Imputing Missing Data Using a Surrogate Biomarker: Analyzing the Incidence of Endometrial Hyperplasia, Selected Statistical Issues in Patient-reported Outcomes, Network Meta-analysis, Detecting Safety Signals Among Adverse Events in Clinical Trials, Applied Meta-analysis Using R, Treatment of Missing Data in Comparative Effectiveness Research, Causal Estimands: A Common Language for Missing Data, Bayesian Subgroup Analysis with Examples, Statistical Methods in Diagnostic Devices, A Question-Based Approach to the Analysis of Safety Data, Analysis of Two-stage Adaptive Seamless Trial Design, and Multiplicity Problems in Clinical Trials – A Regulatory Perspective.

Handbook for Clinical Research

Author : Flora Hammond, MD
Publisher : Demos Medical Publishing
ISBN 13 : 1936287544
Total Pages : 348 pages
Book Rating : 4.9/5 (362 download)

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Book Synopsis Handbook for Clinical Research by : Flora Hammond, MD

Download or read book Handbook for Clinical Research written by Flora Hammond, MD and published by Demos Medical Publishing. This book was released on 2014-08-26 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: With over 80 information-packed chapters, Handbook for Clinical Research delivers the practical insights and expert tips necessary for successful research design, analysis, and implementation. Using clear language and an accessible bullet point format, the authors present the knowledge and expertise developed over time and traditionally shared from mentor to mentee and colleague to colleague. Organized for quick access to key topics and replete with practical examples, the book describes a variety of research designs and statistical methods and explains how to choose the best design for a particular project. Research implementation, including regulatory issues and grant writing, is also covered. The book opens with a section on the basics of research design, discussing the many ways in which studies can be organized, executed, and evaluated. The second section is devoted to statistics and explains how to choose the correct statistical approach and reviews the varieties of data types, descriptive and inferential statistics, methods for demonstrating associations, hypothesis testing and prediction, specialized methods, and considerations in epidemiological studies and measure construction. The third section covers implementation, including how to develop a grant application step by step, the project budget, and the nuts and bolts of the timely and successful completion of a research project and documentation of findings: procedural manuals and case report forms collecting, managing and securing data operational structure and ongoing monitoring and evaluation and ethical and regulatory concerns in research with human subjects. With a concise presentation of the essentials for successful research, the Handbook for Clinical Research is a valuable addition to the library of any student, research professional, or clinician interested in expanding the knowledge base of his or her field. Key Features: Delivers the essential elements, practical insights, and trade secrets for ensuring successful research design, analysis, and implementation Presents the nuts and bolts of statistical analysis Organized for quick access to a wealth of information Replete with practical examples of successful research designs Û from single case designs to meta-analysis - and how to achieve them Addresses research implementation including regulatory issues and grant writing "

Designs for Clinical Trials

Author : David Harrington
Publisher : Springer Science & Business Media
ISBN 13 : 1461401402
Total Pages : 213 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis Designs for Clinical Trials by : David Harrington

Download or read book Designs for Clinical Trials written by David Harrington and published by Springer Science & Business Media. This book was released on 2011-10-09 with total page 213 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book will examine current issues and controversies in the design of clinical trials, including topics in adaptive and sequential designs, the design of correlative genomic studies, the design of studies in which missing data is anticipated. Each chapter will be written by an expert conducting research in the topic of that chapter. As a collection, the chapters would be intended to serve as a guidance for statisticians designing trials.

Biopharmaceutical Applied Statistics Symposium

Author : Karl E. Peace
Publisher : Springer
ISBN 13 : 9811078203
Total Pages : 431 pages
Book Rating : 4.8/5 (11 download)

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Book Synopsis Biopharmaceutical Applied Statistics Symposium by : Karl E. Peace

Download or read book Biopharmaceutical Applied Statistics Symposium written by Karl E. Peace and published by Springer. This book was released on 2018-09-03 with total page 431 pages. Available in PDF, EPUB and Kindle. Book excerpt: This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments – particularly biopharmaceutical clinical trials. The papers were selected from invited presentations at the Biopharmaceutical Applied Statistics Symposium (BASS), which was founded by the first Editor in 1994 and has since become the premier international conference in biopharmaceutical statistics. The primary aims of the BASS are: 1) to raise funding to support graduate students in biostatistics programs, and 2) to provide an opportunity for professionals engaged in pharmaceutical drug research and development to share insights into solving the problems they encounter. The BASS book series is initially divided into three volumes addressing: 1) Design of Clinical Trials; 2) Biostatistical Analysis of Clinical Trials; and 3) Pharmaceutical Applications. This book is the third of the 3-volume book series. The topics covered include: Targeted Learning of Optimal Individualized Treatment Rules under Cost Constraints, Uses of Mixture Normal Distribution in Genomics and Otherwise, Personalized Medicine – Design Considerations, Adaptive Biomarker Subpopulation and Tumor Type Selection in Phase III Oncology Trials, High Dimensional Data in Genomics; Synergy or Additivity - The Importance of Defining the Primary Endpoint, Full Bayesian Adaptive Dose Finding Using Toxicity Probability Interval (TPI), Alpha-recycling for the Analyses of Primary and Secondary Endpoints of Clinical Trials, Expanded Interpretations of Results of Carcinogenicity Studies of Pharmaceuticals, Randomized Clinical Trials for Orphan Drug Development, Mediation Modeling in Randomized Trials with Non-normal Outcome Variables, Statistical Considerations in Using Images in Clinical Trials, Interesting Applications over 30 Years of Consulting, Uncovering Fraud, Misconduct and Other Data Quality Issues in Clinical Trials, Development and Evaluation of High Dimensional Prognostic Models, and Design and Analysis of Biosimilar Studies.

Statistics Applied to Clinical Studies

Author : Ton J. Cleophas
Publisher : Springer Science & Business Media
ISBN 13 : 940072862X
Total Pages : 739 pages
Book Rating : 4.4/5 (7 download)

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Book Synopsis Statistics Applied to Clinical Studies by : Ton J. Cleophas

Download or read book Statistics Applied to Clinical Studies written by Ton J. Cleophas and published by Springer Science & Business Media. This book was released on 2012-02-09 with total page 739 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thanks to the omnipresent computer, current statistics can include data files of many thousands of values, and can perform any exploratory analysis in less than seconds. This development, however fascinating, generally does not lead to simple results. We should not forget that clinical studies are, mostly, for confirming prior hypotheses based on sound arguments, and the simplest tests provide the best power and are adequate for such studies. In the past few years the authors of this 5th edition, as teachers and research supervisors in academic and top-clinical facilities, have been able to closely observe the latest developments in the field of clinical data analysis, and they have been able to assess their performance. In this 5th edition the 47 chapters of the previous edition have been maintained and upgraded according to the current state of the art, and 20 novel chapters have been added after strict selection of the most valuable and promising novel methods. The novel methods are explained using practical examples and step-by-step analyses readily accessible for non-mathematicians. All of the novel chapters have been internationally published by the authors in peer-reviewed journal, including the American Journal of Therapeutics, the European Journal of Clinical Investigation, The International journal of Clinical Pharmacology and therapeutics, and other journals, and permission is granted by all of them to use this material in the current book. We should add that the authors are well-qualified in their fields of knowledge. Professor Zwinderman is president-elect of the International Society of Biostatistics, and Professor Cleophas is past-president of the American College of Angiology. From their expertise they should be able to make adequate selections of modern methods for clinical data analysis for the benefit of physicians, students, and investigators. The authors, although from a different discipline, one clinician and one statistician, have been working and publishing together for over 10 years, and their research of statistical methodology can be characterized as a continued effort to demonstrate that statistics is not mathematics but rather a discipline at the interface of biology and mathematics. They firmly believe that any reader can benefit from this clinical approach to statistical data analysis.

Methods and Applications of Statistics in Clinical Trials, Volume 2

Author : Narayanaswamy Balakrishnan
Publisher : John Wiley & Sons
ISBN 13 : 1118595963
Total Pages : 953 pages
Book Rating : 4.1/5 (185 download)

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Book Synopsis Methods and Applications of Statistics in Clinical Trials, Volume 2 by : Narayanaswamy Balakrishnan

Download or read book Methods and Applications of Statistics in Clinical Trials, Volume 2 written by Narayanaswamy Balakrishnan and published by John Wiley & Sons. This book was released on 2014-06-16 with total page 953 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Multiregional Clinical Trials for Simultaneous Global New Drug Development

Author : Joshua Chen
Publisher : CRC Press
ISBN 13 : 1498701485
Total Pages : 367 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Multiregional Clinical Trials for Simultaneous Global New Drug Development by : Joshua Chen

Download or read book Multiregional Clinical Trials for Simultaneous Global New Drug Development written by Joshua Chen and published by CRC Press. This book was released on 2016-04-21 with total page 367 pages. Available in PDF, EPUB and Kindle. Book excerpt: In a global clinical development strategy, multiregional clinical trials (MRCTs) are vital in the development of innovative medicines. Multiregional Clinical Trials for Simultaneous Global New Drug Development presents a comprehensive overview on the current status of conducting MRCTs in clinical development. International experts from academia, in

Modern Clinical Trial Analysis

Author : Wan Tang
Publisher : Springer Science & Business Media
ISBN 13 : 1461443229
Total Pages : 256 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis Modern Clinical Trial Analysis by : Wan Tang

Download or read book Modern Clinical Trial Analysis written by Wan Tang and published by Springer Science & Business Media. This book was released on 2012-09-05 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume covers classic as well as cutting-edge topics on the analysis of clinical trial data in biomedical and psychosocial research and discusses each topic in an expository and user-friendly fashion. The intent of the book is to provide an overview of the primary statistical and data analytic issues associated with each of the selected topics, followed by a discussion of approaches for tackling such issues and available software packages for carrying out analyses. While classic topics such as survival data analysis, analysis of diagnostic test data and assessment of measurement reliability are well known and covered in depth by available topic-specific texts, this volume serves a different purpose: it provides a quick introduction to each topic for self-learning, particularly for those who have not done any formal coursework on a given topic but must learn it due to its relevance to their multidisciplinary research. In addition, the chapters on these classic topics will reflect issues particularly relevant to modern clinical trials such as longitudinal designs and new methods for analyzing data from such study designs. The coverage of these topics provides a quick introduction to these important statistical issues and methods for addressing them. As with the classic topics, this part of the volume on modern topics will enable researchers to grasp the statistical methods for addressing these emerging issues underlying modern clinical trials and to apply them to their research studies.

Modern Approaches to Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods

Author : Sandeep Menon
Publisher : SAS Institute
ISBN 13 : 1629600849
Total Pages : 364 pages
Book Rating : 4.6/5 (296 download)

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Book Synopsis Modern Approaches to Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods by : Sandeep Menon

Download or read book Modern Approaches to Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods written by Sandeep Menon and published by SAS Institute. This book was released on 2015-12-09 with total page 364 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers domains of modern clinical trial design: classical, group sequential, adaptive, and Bayesian methods applicable to and used in various phases of pharmaceutical development. Written for biostatisticians, pharmacometricians, clinical developers, and statistical programmers involved in the design, analysis, and interpretation of clinical trials, as well as students in graduate and postgraduate programs in statistics or biostatistics, it covers topics including: dose-response and dose-escalation designs; sequential methods to stop trials early for overwhelming efficacy, safety, or futility; Bayesian designs incorporating historical data; adaptive sample size re-estimation and randomization to allocate subjects to effective treatments; population enrichment designs. Methods are illustrated using clinical trials from diverse therapeutic areas, including dermatology, endocrinology, infectious disease, neurology, oncology and rheumatology. --

Design and Analysis of Clinical Trials

Author : Shein-Chung Chow
Publisher : John Wiley & Sons
ISBN 13 : 0471473294
Total Pages : 754 pages
Book Rating : 4.4/5 (714 download)

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Book Synopsis Design and Analysis of Clinical Trials by : Shein-Chung Chow

Download or read book Design and Analysis of Clinical Trials written by Shein-Chung Chow and published by John Wiley & Sons. This book was released on 2008-12-04 with total page 754 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the First Edition of Design and Analysis of Clinical Trials "An excellent book, providing a discussion of the clinical trial process from designing the study through analyzing the data, and to regulatory requirement . . . could easily be used as a classroom text to understand the process in the new drug development area." –Statistical Methods in Medicine A complete and balanced presentation now revised, updated, and expanded As the field of research possibilities expands, the need for a working understanding of how to carry out clinical trials only increases. New developments in the theory and practice of clinical research include a growing body of literature on the subject, new technologies and methodologies, and new guidelines from the International Conference on Harmonization (ICH). Design and Analysis of Clinical Trials, Second Edition provides both a comprehensive, unified presentation of principles and methodologies for various clinical trials, and a well-balanced summary of current regulatory requirements. This unique resource bridges the gap between clinical and statistical disciplines, covering both fields in a lucid and accessible manner. Thoroughly updated from its first edition, the Second Edition of Design and Analysis of Clinical Trials features new topics such as: Clinical trials and regulations, especially those of the ICH Clinical significance, reproducibility, and generalizability Goals of clinical trials and target population New study designs and trial types Sample size determination on equivalence and noninferiority trials, as well as comparing variabilities Also, three entirely new chapters cover: Designs for cancer clinical trials Preparation and implementation of a clinical protocol Data management of a clinical trial Written with the practitioner in mind, the presentation assumes only a minimal mathematical and statistical background for its reader. Instead, the writing emphasizes real-life examples and illustrations from clinical case studies, as well as numerous references-280 of them new to the Second Edition-to the literature. Design and Analysis of Clinical Trials, Second Edition will benefit academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students in these areas by serving as a useful, thorough reference source for clinical research.

Statistical Design, Monitoring, and Analysis of Clinical Trials

Author : Weichung Joe Shih
Publisher : CRC Press
ISBN 13 : 1000462757
Total Pages : 405 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Statistical Design, Monitoring, and Analysis of Clinical Trials by : Weichung Joe Shih

Download or read book Statistical Design, Monitoring, and Analysis of Clinical Trials written by Weichung Joe Shih and published by CRC Press. This book was released on 2021-10-25 with total page 405 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition concentrates on the biostatistics component of clinical trials. This new edition is updated throughout and includes five new chapters. Developed from the authors’ courses taught to public health and medical students, residents, and fellows during the past 20 years, the text shows how biostatistics in clinical trials is an integration of many fundamental scientific principles and statistical methods. The book begins with ethical and safety principles, core trial design concepts, the principles and methods of sample size and power calculation, and analysis of covariance and stratified analysis. It then focuses on sequential designs and methods for two-stage Phase II cancer trials to Phase III group sequential trials, covering monitoring safety, futility, and efficacy. The authors also discuss the development of sample size reestimation and adaptive group sequential procedures, phase 2/3 seamless design and trials with predictive biomarkers, exploit multiple testing procedures, and explain the concept of estimand, intercurrent events, and different missing data processes, and describe how to analyze incomplete data by proper multiple imputations. This text reflects the academic research, commercial development, and public health aspects of clinical trials. It gives students and practitioners a multidisciplinary understanding of the concepts and techniques involved in designing, monitoring, and analyzing various types of trials. The book’s balanced set of homework assignments and in-class exercises are appropriate for students and researchers in (bio)statistics, epidemiology, medicine, pharmacy, and public health.

Clinical Trial Biostatistics and Biopharmaceutical Applications

Author : Walter R. Young
Publisher : CRC Press
ISBN 13 : 1482212188
Total Pages : 582 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis Clinical Trial Biostatistics and Biopharmaceutical Applications by : Walter R. Young

Download or read book Clinical Trial Biostatistics and Biopharmaceutical Applications written by Walter R. Young and published by CRC Press. This book was released on 2014-11-20 with total page 582 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since 1945, "The Annual Deming Conference on Applied Statistics" has been an important event in the statistics profession. In Clinical Trial Biostatistics and Biopharmaceutical Applications, prominent speakers from past Deming conferences present novel biostatistical methodologies in clinical trials as well as up-to-date biostatistical applications from the pharmaceutical industry. Divided into five sections, the book begins with emerging issues in clinical trial design and analysis, including the roles of modeling and simulation, the pros and cons of randomization procedures, the design of Phase II dose-ranging trials, thorough QT/QTc clinical trials, and assay sensitivity and the constancy assumption in noninferiority trials. The second section examines adaptive designs in drug development, discusses the consequences of group-sequential and adaptive designs, and illustrates group sequential design in R. The third section focuses on oncology clinical trials, covering competing risks, escalation with overdose control (EWOC) dose finding, and interval-censored time-to-event data. In the fourth section, the book describes multiple test problems with applications to adaptive designs, graphical approaches to multiple testing, the estimation of simultaneous confidence intervals for multiple comparisons, and weighted parametric multiple testing methods. The final section discusses the statistical analysis of biomarkers from omics technologies, biomarker strategies applicable to clinical development, and the statistical evaluation of surrogate endpoints. This book clarifies important issues when designing and analyzing clinical trials, including several misunderstood and unresolved challenges. It will help readers choose the right method for their biostatistical application. Each chapter is self-contained with references.