Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Statistical Analysis of Proteomics Metabolomics and Lipidomics Data Using Mass Spectrometry written by Susmita Datta and published by Springer. This book was released on 2016-12-15 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents an overview of computational and statistical design and analysis of mass spectrometry-based proteomics, metabolomics, and lipidomics data. This contributed volume provides an introduction to the special aspects of statistical design and analysis with mass spectrometry data for the new omic sciences. The text discusses common aspects of design and analysis between and across all (or most) forms of mass spectrometry, while also providing special examples of application with the most common forms of mass spectrometry. Also covered are applications of computational mass spectrometry not only in clinical study but also in the interpretation of omics data in plant biology studies. Omics research fields are expected to revolutionize biomolecular research by the ability to simultaneously profile many compounds within either patient blood, urine, tissue, or other biological samples. Mass spectrometry is one of the key analytical techniques used in these new omic sciences. Liquid chromatography mass spectrometry, time-of-flight data, and Fourier transform mass spectrometry are but a selection of the measurement platforms available to the modern analyst. Thus in practical proteomics or metabolomics, researchers will not only be confronted with new high dimensional data types—as opposed to the familiar data structures in more classical genomics—but also with great variation between distinct types of mass spectral measurements derived from different platforms, which may complicate analyses, comparison, and interpretation of results.

Download or read book Quantitative Methods in Proteomics written by Katrin Marcus and published by Humana Press. This book was released on 2012-06-08 with total page 539 pages. Available in PDF, EPUB and Kindle. Book excerpt: Protein modifications and changes made to them, as well as the quantities of expressed proteins, can define the various functional stages of the cell. Accordingly, perturbations can lead to various diseases and disorders. As a result, it has become paramount to be able to detect and monitor post-translational modifications and to measure the abundance of proteins within the cell with extreme sensitivity. While protein identification is an almost routine requirement nowadays, reliable techniques for quantifying unmodified proteins (including those that escape detection under standard conditions, such as protein isoforms and membrane proteins) is not routine. Quantitative Methods in Proteomics gives a detailed survey of topics and methods on the principles underlying modern protein analysis, from statistical issues when planning proteomics experiments, to gel-based and mass spectrometry-based applications. The quantification of post-translational modifications is also addressed, followed by the “hot” topics of software and data analysis, as well as various overview chapters which provide a comprehensive overview of existing methods in quantitative proteomics. Written in the successful Methods in Molecular BiologyTM series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible protocols, and notes on troubleshooting and avoiding known pitfalls. Authoritative and easily accessible, Quantitative Methods in Proteomics serves as a comprehensive and competent overview of the important and still growing field of quantitative proteomics.

Download or read book Clinical and Translational Science written by David Robertson and published by Academic Press. This book was released on 2016-11-25 with total page 812 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical and Translational Science: Principles of Human Research, Second Edition, is the most authoritative and timely resource for the broad range of investigators taking on the challenge of clinical and translational science, a field that is devoted to investigating human health and disease, interventions, and outcomes for the purposes of developing new treatment approaches, devices, and modalities to improve health. This updated second edition has been prepared with an international perspective, beginning with fundamental principles, experimental design, epidemiology, traditional and new biostatistical approaches, and investigative tools. It presents complete instruction and guidance from fundamental principles, approaches, and infrastructure, especially for human genetics and genomics, human pharmacology, research in special populations, the societal context of human research, and the future of human research. The book moves on to discuss legal, social, and ethical issues, and concludes with a discussion of future prospects, providing readers with a comprehensive view of this rapidly developing area of science. Introduces novel physiological and therapeutic strategies for engaging the fastest growing scientific field in both the private sector and academic medicine Brings insights from international leaders into the discipline of clinical and translational science Addresses drug discovery, drug repurposing and development, innovative and improved approaches to go/no-go decisions in drug development, and traditional and innovative clinical trial designs

Download or read book Statistics for Pathologists written by Dan A. Milner and published by Demos Medical Publishing. This book was released on 2016-11 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This essential guide provides a clear, accessible review of the use of statistics in pathology studies. Spanning topics such as exploratory data analysis and descriptive statistics as well as the use of comparative statistics, concordance analysis, categorical and continuous data regression analyses, count data, survival analyses, decision point and clustering analysis, and more, this practical book comprehensively demystifies all the statistical knowledge paramount to working in the field. Throughout the guide, the author team highlights common errors and pitfalls that occur when performing tests and when interpreting data and make suggestions for how to avoid mistakes. Chapters are uniformly structured for ease of use and each chapter concludes with reviewquestions to facilitate self-assessment of the reader's skill in use of statistical methods. Statistics for Pathologists teaches trainees, junior investigators, and seasoned pathologists how to look at their data from the point of view of a statistician and determine what tests should be done, how the data and test should be presented, and how to use the tests practically. Learning statistical applications can greatly enhance and simplify the skills necessary to review and present data accurately and this basic understanding of statistics is critical in pathology-related work. Key Features: Clear, concise overviews of every relevant statistical test with application in pathology-related research Includes real published studies to provide examples of use of the tests and interpretation of data Emphasizes how to avoid common errors and pitfalls when conducting tests and interpreting data Provides self-assessment review questions and answers in each chapter Comes with downloadable datasets for the reader so that they can perform statistical analysis tied to the book with popular stats programs

Download or read book Proteomics for Biological Discovery written by Timothy D. Veenstra and published by John Wiley & Sons. This book was released on 2019-05-07 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: An update to the popular guide to proteomics technology applications in biomedical research Building on the strength of the original edition, this book presents the state of the art in the field of proteomics and offers students and scientists new tools and techniques to advance their own research. Written by leading experts in the field, it provides readers with an understanding of new and emerging directions for proteomics research and applications. Proteomics for Biological Discovery begins by discussing the emergence of proteomics technologies and summarizing the potential insights to be gained from proteome-level research. The tools of proteomics, from conventional to novel techniques, are thoroughly covered, from underlying concepts to limitations and future directions. Later chapters provide an overview of the current developments in post-translational modification studies, structural proteomics, biochemical proteomics, applied proteomics, and bioinformatics relevant to proteomics. Chapters cover: Quantitative Proteomics for Differential Protein Expression Profiling; Protein Microarrays; Protein Biomarker Discovery; Biomarker Discovery using Mass Spectrometry Imaging; Protein-Protein Interactions; Mass Spectrometry Of Intact Protein Complexes; Crosslinking Applications in Structural Proteomics; Functional Proteomics; High Resolution Interrogation of Biological Systems via Mass Cytometry; Characterization of Drug-Protein Interactions by Chemoproteomics; Phosphorylation; Large-Scale Phosphoproteomics; and Probing Glycoforms of Individual Proteins Using Antibody-Lectin Sandwich Arrays. Presents a comprehensive and coherent review of the major issues in proteomic technology development, bioinformatics, strategic approaches, and applications Chapters offer a rigorous overview with summary of limitations, emerging approaches, questions, and realistic future industry and basic science applications Features new coverage of mass spectrometry for high throughput proteomic measurements, and novel quantitation strategies such as spectral counting and stable isotope labeling Discusses higher level integrative aspects, including technical challenges and applications for drug discovery Offers new chapters on biomarker discovery, global phosphorylation analysis, proteomic profiling using antibodies, and single cell mass spectrometry Proteomics for Biological Discovery is an excellent advanced resource for graduate students, postdoctoral fellows, and scientists across all the major fields of biomedical science.

Download or read book Pacific Symposium On Biocomputing 2014 written by Russ B Altman and published by World Scientific. This book was released on 2013-11-19 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Pacific Symposium on Biocomputing (PSB) 2014 is an international, multidisciplinary conference for the presentation and discussion of current research in the theory and application of computational methods in problems of biological significance. Presentations are rigorously peer reviewed and are published in an archival proceedings volume. PSB 2014 will be held from January 3 - 7, 2014 in Kohala Coast, Hawaii. Tutorials and workshops will be offered prior to the start of the conference.PSB 2014 will bring together top researchers from the US, the Asian Pacific nations, and around the world to exchange research results and address open issues in all aspects of computational biology. It is a forum for the presentation of work in databases, algorithms, interfaces, visualization, modeling, and other computational methods, as applied to biological problems, with emphasis on applications in data-rich areas of molecular biology.The PSB has been designed to be responsive to the need for critical mass in sub-disciplines within biocomputing. For that reason, it is the only meeting whose sessions are defined dynamically each year in response to specific proposals. PSB sessions are organized by leaders of research in biocomputing's “hot topics.” In this way, the meeting provides an early forum for serious examination of emerging methods and approaches in this rapidly changing field.

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.

Download or read book Statistical Methods for Evaluating Safety in Medical Product Development written by A. Lawrence Gould and published by John Wiley & Sons. This book was released on 2015-02-23 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book gives professionals in clinical research valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It also provides understanding and practical guidance on the application of contemporary statistical methods to contemporary issues in safety evaluation during medical product development. Each chapter provides sufficient detail to the reader to undertake the design and analysis of experiments at various stages of product development, including comprehensive references to the relevant literature. Provides a guide to statistical methods and application in medical product development Assists readers in undertaking design and analysis of experiments at various stages of product development Features case studies throughout the book, as well as, SAS and R code

Download or read book Biomarker Discovery in the Developing World Dissecting the Pipeline for Meeting the Challenges written by Sanjeeva Srivastava and published by Springer. This book was released on 2016-09-30 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is oriented towards post-graduates and researchers with interest in proteomics and its applications in clinical biomarker discovery pipeline. Biomarker discovery has long been the research focus of many life scientists globally. However, the pipeline starting from discovery to validation to regulation as a diagnostic or therapeutic molecule follows a complex trajectory. This book aims to provide an in-depth synopsis on each of these developmental phases attendant to biomarker “life cycle” with emphasis on the emerging and significant role of proteomics. The book begins with a perspective on the role of biorepositories and need for biobanking practices in the developing world. The next chapter focuses on disease heterogeneity in context to geographical bias towards susceptibility to the disease and the role of multi-omics techniques to devise disruptive innovations towards biomarker discovery. Chapter 3 focuses on various omics-based platforms that are currently being used for biomarker discovery, their principles and workflow. Mass spectrometry is emerging as a powerful technology for discovery based studies and targeted validation. Chapter 4 aims at providing a glimpse of the basic workflow and considerations in mass spectrometry based studies. Rapid and aptly targeted research funding has often been deemed as one of the decisive factors enabling excellent science and path breaking innovations. With the need for sophistication required in multi-omics research, Chapter 5 focuses on innovative funding strategies such as crowdfunding and Angel philanthropy. Chapter 6 provides the latest advances in education innovation, the premise and reality of bioeconomy especially in a specific context of the developing world, not to mention the new concept of “social innovation” to link biomarkers with socially responsible and sustainable applications. Chapter 7, in ways similar to biomarkers, discusses the biosimilars as a field that has received much focus and prominence recently due to their immense potential in clinical and pharmaceutical innovation literatures. The broader goal post-biomarker discovery is to translate their use in clinics. However, the road from bench-to-bed side is arduous and complex that is subject to oversight from various national and international regulatory bodies. Chapter 8 underscores these regulatory science considerations and provides a concise overview on intellectual property rights in biomarker discovery. Thus, this book contributed by eminent biomarker scientists, clinicians, translational researchers and social scientists holistically covers the various facets of the biomarker discovery journey from “cell to society” in developing world. The lessons learned and highlighted here are of interest to the life sciences community in a global and interdependent world.

Download or read book Encyclopedia of Bioinformatics and Computational Biology written by and published by Elsevier. This book was released on 2018-08-21 with total page 3421 pages. Available in PDF, EPUB and Kindle. Book excerpt: Encyclopedia of Bioinformatics and Computational Biology: ABC of Bioinformatics, Three Volume Set combines elements of computer science, information technology, mathematics, statistics and biotechnology, providing the methodology and in silico solutions to mine biological data and processes. The book covers Theory, Topics and Applications, with a special focus on Integrative –omics and Systems Biology. The theoretical, methodological underpinnings of BCB, including phylogeny are covered, as are more current areas of focus, such as translational bioinformatics, cheminformatics, and environmental informatics. Finally, Applications provide guidance for commonly asked questions. This major reference work spans basic and cutting-edge methodologies authored by leaders in the field, providing an invaluable resource for students, scientists, professionals in research institutes, and a broad swath of researchers in biotechnology and the biomedical and pharmaceutical industries. Brings together information from computer science, information technology, mathematics, statistics and biotechnology Written and reviewed by leading experts in the field, providing a unique and authoritative resource Focuses on the main theoretical and methodological concepts before expanding on specific topics and applications Includes interactive images, multimedia tools and crosslinking to further resources and databases

Download or read book Modern Approaches to Clinical Trials Using SAS written by Sandeep Menon and published by SAS Institute. This book was released on 2015-12-09 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: Get the tools you need to use SAS® in clinical trial design! Unique and multifaceted, Modern Approaches to Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods, edited by Sandeep M. Menon and Richard C. Zink, thoroughly covers several domains of modern clinical trial design: classical, group sequential, adaptive, and Bayesian methods that are applicable to and widely 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, the book touches on a wide variety of topics, including dose-response and dose-escalation designs; sequential methods to stop trials early for overwhelming efficacy, safety, or futility; Bayesian designs that incorporate historical data; adaptive sample size re-estimation; adaptive randomization to allocate subjects to more effective treatments; and population enrichment designs. Methods are illustrated using clinical trials from diverse therapeutic areas, including dermatology, endocrinology, infectious disease, neurology, oncology, and rheumatology. Individual chapters are authored by renowned contributors, experts, and key opinion leaders from the pharmaceutical/medical device industry or academia. Numerous real-world examples and sample SAS code enable users to readily apply novel clinical trial design and analysis methodologies in practice.

Download or read book Encyclopedia of Biopharmaceutical Statistics Four Volume Set written by Shein-Chung Chow and published by CRC Press. This book was released on 2018-09-03 with total page 4031 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.

Download or read book Medical Product Safety Evaluation written by Jie Chen and published by CRC Press. This book was released on 2018-09-03 with total page 220 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. The book is designed not only for biopharmaceutical professionals, such as statisticians, safety specialists, pharmacovigilance experts, and pharmacoepidemiologists, who can use the book as self-learning materials or in short courses or training programs, but also for graduate students in statistics and biomedical data science for a one-semester course. Each chapter provides supplements and problems as more readings and exercises.

Download or read book Principles of Translational Science in Medicine written by Martin Wehling and published by Academic Press. This book was released on 2021-07-15 with total page 495 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles of Translational Science in Medicine: From Bench to Bedside, Third Edition, provides an update on major achievements in the translation of research into medically relevant results and therapeutics. The book presents a thorough discussion of biomarkers, early human trials, and networking models, and includes institutional and industrial support systems. It also covers algorithms that have influenced all major areas of biomedical research in recent years, resulting in an increasing number of new chemical/biological entities (NCEs or NBEs) as shown in FDA statistics. New chapters include: Translation in Oncology, Biologicals, and Orphan Drugs. The book is ideal for use as a guide for biomedical scientists to establish a systematic approach to translational medicine and is written by worldwide experts in their respective fields. - Includes state-of-the-art principles, tools such as biomarkers and early clinical trials, algorithms of translational science in medicine - Provides in-depth description of special translational aspects in the currently most successful areas of clinical translation, namely oncology and immunology - Covers status of institutionalization of translational medicine, networking structures and outcomes at the level of marketing authorization

Download or read book Statistical Methods for Global Health and Epidemiology written by Xinguang Chen and published by Springer Nature. This book was released on 2020-04-13 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines statistical methods and models used in the fields of global health and epidemiology. It includes methods such as innovative probability sampling, data harmonization and encryption, and advanced descriptive, analytical and monitory methods. Program codes using R are included as well as real data examples. Contemporary global health and epidemiology involves a myriad of medical and health challenges, including inequality of treatment, the HIV/AIDS epidemic and its subsequent control, the flu, cancer, tobacco control, drug use, and environmental pollution. In addition to its vast scales and telescopic perspective; addressing global health concerns often involves examining resource-limited populations with large geographic, socioeconomic diversities. Therefore, advancing global health requires new epidemiological design, new data, and new methods for sampling, data processing, and statistical analysis. This book provides global health researchers with methods that will enable access to and utilization of existing data. Featuring contributions from both epidemiological and biostatistical scholars, this book is a practical resource for researchers, practitioners, and students in solving global health problems in research, education, training, and consultation.

Download or read book Statistical Methods in Drug Combination Studies written by Wei Zhao and published by CRC Press. This book was released on 2014-12-19 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: The growing interest in using combination drugs to treat various complex diseases has spawned the development of many novel statistical methodologies. The theoretical development, coupled with advances in statistical computing, makes it possible to apply these emerging statistical methods in in vitro and in vivo drug combination assessments. Howeve