Biomarker Analysis In Clinical Trials With R
DOWNLOAD
Download Biomarker Analysis In Clinical Trials With R PDF/ePub or read online books in Mobi eBooks. Click Download or Read Online button to get Biomarker Analysis In Clinical Trials With R book now. This website allows unlimited access to, at the time of writing, more than 1.5 million titles, including hundreds of thousands of titles in various foreign languages. If the content not found or just blank you must refresh this page
Biomarker Analysis In Clinical Trials With R
DOWNLOAD
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.
Applied Meta Analysis With R And Stata
DOWNLOAD
Author : Ding-Geng (Din) Chen
language : en
Publisher: CRC Press
Release Date : 2021-03-30
Applied Meta Analysis With R And Stata written by Ding-Geng (Din) Chen and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-03-30 with Computers categories.
Review of the First Edition: The authors strive to reduce theory to a minimum, which makes it a self-learning text that is comprehensible for biologists, physicians, etc. who lack an advanced mathematics background. Unlike in many other textbooks, R is not introduced with meaningless toy examples; instead the reader is taken by the hand and shown around some analyses, graphics, and simulations directly relating to meta-analysis... A useful hands-on guide for practitioners who want to familiarize themselves with the fundamentals of meta-analysis and get started without having to plough through theorems and proofs. —Journal of Applied Statistics Statistical Meta-Analysis with R and Stata, Second Edition provides a thorough presentation of statistical meta-analyses (MA) with step-by-step implementations using R/Stata. The authors develop analysis step by step using appropriate R/Stata functions, which enables readers to gain an understanding of meta-analysis methods and R/Stata implementation so that they can use these two popular software packages to analyze their own meta-data. Each chapter gives examples of real studies compiled from the literature. After presenting the data and necessary background for understanding the applications, various methods for analyzing meta-data are introduced. The authors then develop analysis code using the appropriate R/Stata packages and functions. What’s New in the Second Edition: Adds Stata programs along with the R programs for meta-analysis Updates all the statistical meta-analyses with R/Stata programs Covers fixed-effects and random-effects MA, meta-regression, MA with rare-event, and MA-IPD vs MA-SS Adds five new chapters on multivariate MA, publication bias, missing data in MA, MA in evaluating diagnostic accuracy, and network MA Suitable as a graduate-level text for a meta-data analysis course, the book is also a valuable reference for practitioners and biostatisticians (even those with little or no experience in using R or Stata) in public health, medical research, governmental agencies, and the pharmaceutical industry.
Biomarkers In Drug Development
DOWNLOAD
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.
Design And Analysis Of Clinical Trials For Predictive Medicine
DOWNLOAD
Author : Shigeyuki Matsui
language : en
Publisher: CRC Press
Release Date : 2015-03-19
Design And Analysis Of Clinical Trials For Predictive Medicine written by Shigeyuki Matsui and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-03-19 with Mathematics categories.
Design and Analysis of Clinical Trials for Predictive Medicine provides statistical guidance on conducting clinical trials for predictive medicine. It covers statistical topics relevant to the main clinical research phases for developing molecular diagnostics and therapeutics-from identifying molecular biomarkers using DNA microarrays to confirming
Clinical Trial Optimization Using R
DOWNLOAD
Author : Alex Dmitrienko
language : en
Publisher: CRC Press
Release Date : 2017-08-10
Clinical Trial Optimization Using R written by Alex Dmitrienko and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-08-10 with Mathematics categories.
Clinical Trial Optimization Using R explores a unified and broadly applicable framework for optimizing decision making and strategy selection in clinical development, through a series of examples and case studies. It provides the clinical researcher with a powerful evaluation paradigm, as well as supportive R tools, to evaluate and select among simultaneous competing designs or analysis options. It is applicable broadly to statisticians and other quantitative clinical trialists, who have an interest in optimizing clinical trials, clinical trial programs, or associated analytics and decision making. This book presents in depth the Clinical Scenario Evaluation (CSE) framework, and discusses optimization strategies, including the quantitative assessment of tradeoffs. A variety of common development challenges are evaluated as case studies, and used to show how this framework both simplifies and optimizes strategy selection. Specific settings include optimizing adaptive designs, multiplicity and subgroup analysis strategies, and overall development decision-making criteria around Go/No-Go. After this book, the reader will be equipped to extend the CSE framework to their particular development challenges as well.
Design And Analysis Of Clinical Trials
DOWNLOAD
Author : Shein-Chung Chow
language : en
Publisher: John Wiley & Sons
Release Date : 2013-09-30
Design And Analysis Of Clinical Trials written by Shein-Chung Chow 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 2013-09-30 with Mathematics categories.
Praise for the Second Edition: “...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite.” —Journal of Clinical Research Best Practices The Third Edition of Design and Analysis of Clinical Trials provides complete, comprehensive, and expanded coverage of recent health treatments and interventions. Featuring a unified presentation, the book provides a well-balanced summary of current regulatory requirements and recently developed statistical methods as well as an overview of the various designs and analyses that are utilized at different stages of clinical research and development. Additional features of this Third Edition include: • New chapters on biomarker development and target clinical trials, adaptive design, trials for evaluating diagnostic devices, statistical methods for translational medicine, and traditional Chinese medicine • A balanced overview of current and emerging clinical issues as well as newly developed statistical methodologies • Practical examples of clinical trials that demonstrate everyday applicability, with illustrations and examples to explain key concepts • New sections on bridging studies and global trials, QT studies, multinational trials, comparative effectiveness trials, and the analysis of QT/QTc prolongation • A complete and balanced presentation of clinical and scientific issues, statistical concepts, and methodologies for bridging clinical and statistical disciplines • An update of each chapter that reflects changes in regulatory requirements for the drug review and approval process and recent developments in statistical design and methodology for clinical research and development Design and Analysis of Clinical Trials, Third Edition continues to be an ideal clinical research reference for academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students.
Sharing Clinical Trial Data
DOWNLOAD
Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2015-04-20
Sharing Clinical Trial Data written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-04-20 with Medical categories.
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Emerging Therapeutic Targets Potential Diagnostic Or Prognostic Markers For Colorectal Cancer
DOWNLOAD
Author : Muzafar Ahmad Macha
language : en
Publisher: Frontiers Media SA
Release Date : 2023-06-09
Emerging Therapeutic Targets Potential Diagnostic Or Prognostic Markers For Colorectal Cancer written by Muzafar Ahmad Macha and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-06-09 with Medical categories.
Critical Issues In Head And Neck Oncology
DOWNLOAD
Author : Jan B. Vermorken
language : en
Publisher: Springer Nature
Release Date : 2025-06-24
Critical Issues In Head And Neck Oncology written by Jan B. Vermorken and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-06-24 with Medical categories.
This is an open access book. With a wealth of exciting data emerging in this rapidly evolving field, this book reviews state-of-the-art knowledge with emphasis on multidisciplinary decision making and management of head and neck cancer. Significant detail is provided on a wide range of topics including: oral potentially malignant disorders, cell-based assays for drug discovery and drug evaluation, the role of precision medicine (genomics and beyond), innovations in systemic therapy (including metronomic chemotherapy and immunotherapy), surgery (including partial laryngeal surgery and quality of reconstruction) and radiotherapy (including FLASH-therapy) in different disease settings taking into account their impact on benefit/risk ratio. In addition, specific topics such as hypoxia, hyperthermia, intratumoral drug administration, noninvasive biomarkers, local therapy in metastatic head and neck cancer, sentinel lymph node biopsy in cN0 early-stage oral cavity cancer, prognostic factors in HPV-positive oropharyngeal cancer, molecular characterization of salivary gland cancer (including implications for treatment) and strategies to improve outcome in salivary duct carcinoma are discussed. All disciplines involved in the treatment of head and neck cancer are covered with a focus on translation into daily practice. The 9th-THNO is designed for medical oncologists, head and neck surgeons, radiation oncologists, otolaryngologists, and other medical professionals involved in the treatment and care of patients with head and neck cancer.
Handbook Of Lc Ms Bioanalysis
DOWNLOAD
Author : Wenkui Li
language : en
Publisher: John Wiley & Sons
Release Date : 2013-10-21
Handbook Of Lc Ms Bioanalysis written by Wenkui Li 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 2013-10-21 with Science categories.
Consolidates the information LC-MS bioanalytical scientists need to analyze small molecules and macromolecules The field of bioanalysis has advanced rapidly, propelled by new approaches for developing bioanalytical methods, new liquid chromatographic (LC) techniques, and new mass spectrometric (MS) instruments. Moreover, there are a host of guidelines and regulations designed to ensure the quality of bioanalytical results. Presenting the best practices, experimental protocols, and the latest understanding of regulations, this book offers a comprehensive review of LC-MS bioanalysis of small molecules and macromolecules. It not only addresses the needs of bioanalytical scientists working on routine projects, but also explores advanced and emerging technologies such as high-resolution mass spectrometry and dried blood spot microsampling. Handbook of LC-MS Bioanalysis features contributions from an international team of leading bioanalytical scientists. Their contributions reflect a review of the latest findings, practices, and regulations as well as their own firsthand analytical laboratory experience. The book thoroughly examines: Fundamentals of LC-MS bioanalysis in drug discovery, drug development, and therapeutic drug monitoring The current understanding of regulations governing LC-MS bioanalysis Best practices and detailed technical instructions for LC-MS bioanalysis method development, validation, and stability assessment of analyte(s) of interest Experimental guidelines and protocols for quantitative LC-MS bioanalysis of challenging molecules, including pro-drugs, acyl glucuronides, N-oxides, reactive compounds, and photosensitive and autooxidative compounds With its focus on current bioanalytical practice, Handbook of LC-MS Bioanalysis enables bioanalytical scientists to develop and validate robust LC-MS assay methods, all in compliance with current regulations and standards.