Statistical Methods In Biomarker And Early Clinical Development
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Statistical Methods In Biomarker And Early Clinical Development
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Author : Liang Fang
language : en
Publisher: Springer Nature
Release Date : 2019-12-26
Statistical Methods In Biomarker And Early Clinical Development written by Liang Fang and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-12-26 with Medical categories.
This contributed volume offers a much-needed overview of the statistical methods in early clinical drug and biomarker development. Chapters are written by expert statisticians with extensive experience in the pharmaceutical industry and regulatory agencies. Because of this, the data presented is often accompanied by real world case studies, which will help make examples more tangible for readers. The many applications of statistics in drug development are covered in detail, making this volume a must-have reference. Biomarker development and early clinical development are the two critical areas on which the book focuses. By having the two sections of the book dedicated to each of these topics, readers will have a more complete understanding of how applying statistical methods to early drug development can help identify the right drug for the right patient at the right dose. Also presented are exciting applications of machine learning and statistical modeling, along with innovative methods and state-of-the-art advances, making this a timely and practical resource. This volume is ideal for statisticians, researchers, and professionals interested in pharmaceutical research and development. Readers should be familiar with the fundamentals of statistics and clinical trials.
Biomarker Analysis In Clinical Trials With R
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Author : Nusrat Rabbee
language : en
Publisher: CRC Press
Release Date : 2020-03-11
Biomarker Analysis In Clinical Trials With R written by Nusrat Rabbee and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-03-11 with Mathematics categories.
The world is awash in data. This volume of data will continue to increase. In the pharmaceutical industry, much of this data explosion has happened around biomarker data. Great statisticians are needed to derive understanding from these data. This book will guide you as you begin the journey into communicating, understanding and synthesizing biomarker data. -From the Foreword, Jared Christensen, Vice President, Biostatistics Early Clinical Development, Pfizer, Inc. Biomarker Analysis in Clinical Trials with R offers practical guidance to statisticians in the pharmaceutical industry on how to incorporate biomarker data analysis in clinical trial studies. The book discusses the appropriate statistical methods for evaluating pharmacodynamic, predictive and surrogate biomarkers for delivering increased value in the drug development process. The topic of combining multiple biomarkers to predict drug response using machine learning is covered. Featuring copious reproducible code and examples in R, the book helps students, researchers and biostatisticians get started in tackling the hard problems of designing and analyzing trials with biomarkers. Features: Analysis of pharmacodynamic biomarkers for lending evidence target modulation. Design and analysis of trials with a predictive biomarker. Framework for analyzing surrogate biomarkers. Methods for combining multiple biomarkers to predict treatment response. Offers a biomarker statistical analysis plan. R code, data and models are given for each part: including regression models for survival and longitudinal data, as well as statistical learning models, such as graphical models and penalized regression models.
Biomarkers In Drug Development
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Author : Michael R. Bleavins
language : en
Publisher: John Wiley & Sons
Release Date : 2011-09-20
Biomarkers In Drug Development written by Michael R. Bleavins and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-09-20 with Medical categories.
Discover how biomarkers can boost the success rate of drug development efforts As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine. Biomarkers in Drug Development is divided into eight parts: Part One offers an overview of biomarkers and their role in drug development. Part Two highlights important technologies to help researchers identify new biomarkers. Part Three examines the characterization and validation process for both drugs and diagnostics, and provides practical advice on appropriate statistical methods to ensure that biomarkers fulfill their intended purpose. Parts Four through Six examine the application of biomarkers in discovery, preclinical safety assessment, clinical trials, and translational medicine. Part Seven focuses on lessons learned and the practical aspects of implementing biomarkers in drug development programs. Part Eight explores future trends and issues, including data integration, personalized medicine, and ethical concerns. Each of the thirty-eight chapters was contributed by one or more leading experts, including scientists from biotechnology and pharmaceutical firms, academia, and the U.S. Food and Drug Administration. Their contributions offer pharmaceutical and clinical researchers the most up-to-date understanding of the strategies used for and applications of biomarkers in drug development.
The Statistical Evaluation Of Medical Tests For Classification And Prediction
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Author : Margaret Sullivan Pepe
language : en
Publisher: OUP Oxford
Release Date : 2003-03-13
The Statistical Evaluation Of Medical Tests For Classification And Prediction written by Margaret Sullivan Pepe and has been published by OUP Oxford this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-03-13 with Medical categories.
The use of clinical and laboratory information to detect conditions and predict patient outcomes is a mainstay of medical practice. Modern biotechnology offers increasing potential to develop sophisticated tests for these purposes. This book describes the statistical concepts and techniques for evaluating the accuracy of medical tests. Worked examples include applications to cancer biomarker studies, prospective disease screening studies, diagnostic radiology studies and audiology testing studies. The statistical methodology can be broadly applied for evaluating classifiers and to problems beyond medical settings. Several measures for quantifying test accuracy are described including the Receiver Operating Characteristic Curve. Pepe presents statistical procedures for the estimation and comparison of those measures among tests. Regression frameworks for assessing factors that influence test accuracy and for comparing tests while adjusting for such factors are presented. The sequence of research steps involved in the development of a test is considered in some detail. Sample size calculations and other issues pertinent to study design are described for tests at various phases of development. In addition, the impacts of missing data and imperfect reference data are addressed. These problems often occur in practice, and modern statistical procedures for dealing with them are discussed. Additional topics that are covered include: meta-analysis for summarizing the results of multiple studies of a test; the evaluation of markers for predicting event time data; and procedures for combining the results of multiple tests to improve classification. This book should be of interest to quantitative researchers and practicing statisticians. The book also covers the theoretical foundations for statistical inference and should therefore be of interest to academic statisticians including those involved in statistical methodological research in this field.
Textbook Of Clinical Trials In Oncology
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Author : Susan Halabi
language : en
Publisher: CRC Press
Release Date : 2019-04-24
Textbook Of Clinical Trials In Oncology written by Susan Halabi and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-04-24 with Medical categories.
There is an increasing need for educational resources for statisticians and investigators. Reflecting this, the goal of this book is to provide readers with a sound foundation in the statistical design, conduct, and analysis of clinical trials. Furthermore, it is intended as a guide for statisticians and investigators with minimal clinical trial experience who are interested in pursuing a career in this area. The advancement in genetic and molecular technologies have revolutionized drug development. In recent years, clinical trials have become increasingly sophisticated as they incorporate genomic studies, and efficient designs (such as basket and umbrella trials) have permeated the field. This book offers the requisite background and expert guidance for the innovative statistical design and analysis of clinical trials in oncology. Key Features: Cutting-edge topics with appropriate technical background Built around case studies which give the work a "hands-on" approach Real examples of flaws in previously reported clinical trials and how to avoid them Access to statistical code on the book’s website Chapters written by internationally recognized statisticians from academia and pharmaceutical companies Carefully edited to ensure consistency in style, level, and approach Topics covered include innovating phase I and II designs, trials in immune-oncology and rare diseases, among many others
Translational Medicine
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Author : Dennis Cosmatos
language : en
Publisher: CRC Press
Release Date : 2008-12-17
Translational Medicine written by Dennis Cosmatos and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-12-17 with Mathematics categories.
Examines Critical Decisions for Transitioning Lab Science to a Clinical SettingThe development of therapeutic pharmaceutical compounds is becoming more expensive, and the success rates for getting such treatments approved for marketing and to the patients is decreasing. As a result, translational medicine (TM) is becoming increasingly important in
Comprehensive Biomarker Discovery And Validation For Clinical Application
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Author : Péter Horvatovich
language : en
Publisher: Royal Society of Chemistry
Release Date : 2013-06-17
Comprehensive Biomarker Discovery And Validation For Clinical Application written by Péter Horvatovich and has been published by Royal Society of Chemistry this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-06-17 with Science categories.
Comprehensive Biomarker Discovery and Validation for Clinical Application provides the reader with an extensive introduction into all aspects of proteomics biomarker discovery, validation and development. It discusses the current status of science and technology, its limitations, bottlenecks as well as future development trends to improve the success rate of translating biomarker discovery into useful clinical tests. The most important feature of the book is to provide an overview of current technologies and the challenges encountered during biomarker discovery and validation, such as patient selection, sample handling, data processing, statistical analysis and registration and approval of validated biomarkers through European and US regulatory authorities. The authors introduce the reader to each of these topics in significant detail and provide examples or guidelines for best practice. There are prominent chapters included on biomarkers in translational and personalised medicine; an introduction to regulatory affairs and bring biomarkers to the market; biomarker discovery and the use of mass spectrometry based profiling platforms; MALDI imaging techniques in tissue-based biomarkers discovery and a clinical application study on the use of diagnostic assays for early diagnosis of heart failure using various proteomic methods. The book concludes with a final chapter on future trends in biomarker discovery and validation. The book targets a readership of industrial and academic researchers that are involved in biomarker discovery and validation or that manage biobanks, develop sample preparation methods, analytical profiling systems and bioinformatics tools. Common pitfalls and success stories in biomarker discovery are highlighted and guidelines for best practice are provided for the different parts of the procedure. The book will be an essential information resource for scientists working in the field.
Innovative Strategies Statistical Solutions And Simulations For Modern Clinical Trials
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Author : Mark Chang
language : en
Publisher: CRC Press
Release Date : 2019-03-20
Innovative Strategies Statistical Solutions And Simulations For Modern Clinical Trials written by Mark Chang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-03-20 with Medical categories.
"This is truly an outstanding book. [It] brings together all of the latest research in clinical trials methodology and how it can be applied to drug development.... Chang et al provide applications to industry-supported trials. This will allow statisticians in the industry community to take these methods seriously." Jay Herson, Johns Hopkins University The pharmaceutical industry's approach to drug discovery and development has rapidly transformed in the last decade from the more traditional Research and Development (R & D) approach to a more innovative approach in which strategies are employed to compress and optimize the clinical development plan and associated timelines. However, these strategies are generally being considered on an individual trial basis and not as part of a fully integrated overall development program. Such optimization at the trial level is somewhat near-sighted and does not ensure cost, time, or development efficiency of the overall program. This book seeks to address this imbalance by establishing a statistical framework for overall/global clinical development optimization and providing tactics and techniques to support such optimization, including clinical trial simulations. Provides a statistical framework for achieve global optimization in each phase of the drug development process. Describes specific techniques to support optimization including adaptive designs, precision medicine, survival-endpoints, dose finding and multiple testing. Gives practical approaches to handling missing data in clinical trials using SAS. Looks at key controversial issues from both a clinical and statistical perspective. Presents a generous number of case studies from multiple therapeutic areas that help motivate and illustrate the statistical methods introduced in the book. Puts great emphasis on software implementation of the statistical methods with multiple examples of software code (both SAS and R). It is important for statisticians to possess a deep knowledge of the drug development process beyond statistical considerations. For these reasons, this book incorporates both statistical and "clinical/medical" perspectives.
Drug Discovery Toxicology
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Author : Yvonne Will
language : en
Publisher: John Wiley & Sons
Release Date : 2016-03-16
Drug Discovery Toxicology written by Yvonne Will and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-03-16 with Medical categories.
As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods at each step of the drug discovery process. • Guides researchers as to what drug safety experiments are both practical and useful • Covers a variety of key topics – safety lead optimization, in vitro-in vivo translation, organ toxicology, ADME, animal models, biomarkers, and –omics tools • Describes what experiments are possible and useful and offers a view into the future, indicating key areas to watch for new predictive methods • Features contributions from firsthand industry experience, giving readers insight into the strategy and execution of predictive toxicology practices
Clinical Trials In Older Adults
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Author : Antonio Cherubini
language : en
Publisher: John Wiley & Sons
Release Date : 2016-01-13
Clinical Trials In Older Adults written by Antonio Cherubini and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-01-13 with Medical categories.
Clinical Trials in Older Adults is the first book to consider the methodological issues underlying the evaluation of new treatments in older people. Provides information on the methodology, monitoring and regulations for those planning to conduct a clinical trials involving older adults Contains examples of ongoing trials involving older adults, and presents the main characteristics of many recently published Depicts how the issues regarding older adults in clinical trials could be properly addressed with the appropriate study design and conduct Identifies key issues in performing clinical trials in older patients with common geriatric conditions, i.e. Alzheimer’s dementia, depression, low muscle mass, cancer