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Author: Zhen Chen Publisher: Springer ISBN: 3319126946 Category : Medical Languages : en Pages : 550
Book Description
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.
Author: Zhen Chen Publisher: Springer ISBN: 3319126946 Category : Medical Languages : en Pages : 550
Book Description
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.
Author: Karl E. Peace Publisher: Springer ISBN: 9811078297 Category : Medical Languages : en Pages : 409
Book Description
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.
Author: Karl E. Peace Publisher: ISBN: 9789811078309 Category : Biopharmaceutics Languages : en Pages :
Book Description
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.--
Author: Narayanaswamy Balakrishnan Publisher: John Wiley & Sons ISBN: 1118595912 Category : Medical Languages : en Pages : 937
Book Description
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.
Author: Jianchang Lin Publisher: Springer ISBN: 3319425684 Category : Medical Languages : en Pages : 351
Book Description
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.
Author: Flora Hammond, MD Publisher: Demos Medical Publishing ISBN: 1936287544 Category : Medical Languages : en Pages : 348
Book Description
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 "
Author: Karl E. Peace Publisher: Springer ISBN: 9811078262 Category : Medical Languages : en Pages : 245
Book Description
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.
Author: Ton J. Cleophas Publisher: Springer Science & Business Media ISBN: 940072862X Category : Medical Languages : en Pages : 739
Book Description
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.
Author: David Harrington Publisher: Springer Science & Business Media ISBN: 1461401402 Category : Medical Languages : en Pages : 213
Book Description
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.
Author: Karl E. Peace Publisher: Springer ISBN: 9811078203 Category : Medical Languages : en Pages : 426
Book Description
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.