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 : 546 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 546 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 : 409 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 409 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.

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.

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.--

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

Author : Jianchang Lin
Publisher : Springer
ISBN 13 : 3319425684
Total Pages : 359 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 359 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.

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.

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: The majority of physicians are poorly knowledgeable about statistics and research design, yet are expected to do clinical research and write articles (if in academia) or, at the very least, to read the literature critically and provide evidence-based care to patients. The basic skills involved are touched on very minimally in residency, but not in enough depth for an untrained investigator to successfully design or conduct a study, or analyze research findings in any meaningful way. This volume is intended as a “quick fix”, allowing readers to look up information rapidly about various design types and statistical methods to see what the pros, cons, and indications for each are. Research implementation, including regulatory issues and grant writing, is also covered. The book is unique in physical medicine and rehabilitation, and with the increased emphasis on outcomes measurement and push toward a national agenda for disability research, will appeal both to investigators planning and executing studies and clinicians looking to better understand how the findings impact their practice. A list of topics with an outline of headings for each of the sections is attached.

Applied Statistics in the Pharmaceutical Industry

Author : Steven P. Millard
Publisher : Springer Science & Business Media
ISBN 13 : 1475734662
Total Pages : 518 pages
Book Rating : 4.4/5 (757 download)

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Book Synopsis Applied Statistics in the Pharmaceutical Industry by : Steven P. Millard

Download or read book Applied Statistics in the Pharmaceutical Industry written by Steven P. Millard and published by Springer Science & Business Media. This book was released on 2013-11-09 with total page 518 pages. Available in PDF, EPUB and Kindle. Book excerpt: Providing a general guide to statistical methods used in the pharmaceutical industry, and illustrating how to use S-PLUS to implement these methods, the book explains why S-PLUS is a useful software package and discusses the results and implications of each particular application. It is targeted at graduates in biostatistics, statisticians involved in the industry as research scientists, regulators, academics, and/or consultants who want to know more about how to use S-PLUS and learn about other sub-fields within the industry, as well as statisticians in other fields who want to know more about statistical applications in the pharmaceutical industry.

Biopharmaceutical Applied Statistics Symposium

Author : Karl E. Peace
Publisher : Springer
ISBN 13 : 9811078262
Total Pages : 245 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 245 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.

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

Biopharmaceutical Applied Statistics Symposium

Author : Karl E. Peace
Publisher : Springer
ISBN 13 : 9811078203
Total Pages : 426 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 426 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.

Multiregional Clinical Trials for Simultaneous Global New Drug Development

Author : Joshua Chen
Publisher : CRC Press
ISBN 13 : 1498701485
Total Pages : 375 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 375 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 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. --

Statistical Design and Analysis of Clinical Trials

Author : Weichung Joe Shih
Publisher : CRC Press
ISBN 13 : 1482250500
Total Pages : 240 pages
Book Rating : 4.4/5 (822 download)

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

Download or read book Statistical Design and Analysis of Clinical Trials written by Weichung Joe Shih and published by CRC Press. This book was released on 2015-07-28 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical Design and Analysis of Clinical Trials: Principles and Methods concentrates on the biostatistics component of clinical trials. Developed from the authors' courses taught to public health and medical students, residents, and fellows during the past 15 years, the text shows how biostatistics in clinical trials is an integration of many fu

Clinical Trial Biostatistics and Biopharmaceutical Applications

Author : Walter R. Young
Publisher : CRC Press
ISBN 13 : 1482212196
Total Pages : 574 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 574 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

Statistical Design, Monitoring, and Analysis of Clinical Trials

Author : Weichung Joe Shih
Publisher : CRC Press
ISBN 13 : 1000462811
Total Pages : 320 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 2021-10-26 with total page 320 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.

Analysis of Clinical Trials Using SAS

Author : Alex Dmitrienko
Publisher : SAS Institute
ISBN 13 : 1635261465
Total Pages : 410 pages
Book Rating : 4.6/5 (352 download)

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Book Synopsis Analysis of Clinical Trials Using SAS by : Alex Dmitrienko

Download or read book Analysis of Clinical Trials Using SAS written by Alex Dmitrienko and published by SAS Institute. This book was released on 2017-07-17 with total page 410 pages. Available in PDF, EPUB and Kindle. Book excerpt: Analysis of Clinical Trials Using SAS®: A Practical Guide, Second Edition bridges the gap between modern statistical methodology and real-world clinical trial applications. Tutorial material and step-by-step instructions illustrated with examples from actual trials serve to define relevant statistical approaches, describe their clinical trial applications, and implement the approaches rapidly and efficiently using the power of SAS. Topics reflect the International Conference on Harmonization (ICH) guidelines for the pharmaceutical industry and address important statistical problems encountered in clinical trials. Commonly used methods are covered, including dose-escalation and dose-finding methods that are applied in Phase I and Phase II clinical trials, as well as important trial designs and analysis strategies that are employed in Phase II and Phase III clinical trials, such as multiplicity adjustment, data monitoring, and methods for handling incomplete data. This book also features recommendations from clinical trial experts and a discussion of relevant regulatory guidelines. This new edition includes more examples and case studies, new approaches for addressing statistical problems, and the following new technological updates: SAS procedures used in group sequential trials (PROC SEQDESIGN and PROC SEQTEST) SAS procedures used in repeated measures analysis (PROC GLIMMIX and PROC GEE) macros for implementing a broad range of randomization-based methods in clinical trials, performing complex multiplicity adjustments, and investigating the design and analysis of early phase trials (Phase I dose-escalation trials and Phase II dose-finding trials) Clinical statisticians, research scientists, and graduate students in biostatistics will greatly benefit from the decades of clinical research experience and the ready-to-use SAS macros compiled in this book.