Statistical Topics In Health Economics And Outcomes Research
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Statistical Topics In Health Economics And Outcomes Research
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Author : Demissie Alemayehu, PhD
language : en
Publisher: CRC Press
Release Date : 2017-11-22
Statistical Topics In Health Economics And Outcomes Research written by Demissie Alemayehu, PhD and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-11-22 with Mathematics categories.
With ever-rising healthcare costs, evidence generation through Health Economics and Outcomes Research (HEOR) plays an increasingly important role in decision-making about the allocation of resources. Accordingly, it is now customary for health technology assessment and reimbursement agencies to request for HEOR evidence, in addition to data from clinical trials, to inform decisions about patient access to new treatment options. While there is a great deal of literature on HEOR, there is a need for a volume that presents a coherent and unified review of the major issues that arise in application, especially from a statistical perspective. Statistical Topics in Health Economics and Outcomes Research fulfils that need by presenting an overview of the key analytical issues and best practice. Special attention is paid to key assumptions and other salient features of statistical methods customarily used in the area, and appropriate and relatively comprehensive references are made to emerging trends. The content of the book is purposefully designed to be accessible to readers with basic quantitative backgrounds, while providing an in-depth coverage of relatively complex statistical issues. The book will make a very useful reference for researchers in the pharmaceutical industry, academia, and research institutions involved with HEOR studies. The targeted readers may include statisticians, data scientists, epidemiologists, outcomes researchers, health economists, and healthcare policy and decision-makers.
Interface Between Regulation And Statistics In Drug Development
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Author : Demissie Alemayehu
language : en
Publisher: CRC Press
Release Date : 2020-11-11
Interface Between Regulation And Statistics In Drug Development written by Demissie Alemayehu and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-11-11 with Mathematics categories.
With the critical role of statistics in the design, conduct, analysis and reporting of clinical trials or observational studies intended for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues related to drug development. However, the available literature on this important topic is sporadic, and often not readily accessible to drug developers or regulatory personnel. This book provides a systematic exposition of the interplay between the two disciplines, including emerging themes pertaining to the acceleration of the development of pharmaceutical medicines to serve patients with unmet needs. Features: Regulatory and statistical interactions throughout the drug development continuum The critical role of the statistician in relation to the changing regulatory and healthcare landscapes Statistical issues that commonly arise in the course of drug development and regulatory interactions Trending topics in drug development, with emphasis on current regulatory thinking and the associated challenges and opportunities The book is designed to be accessible to readers with an intermediate knowledge of statistics, and can be a useful resource to statisticians, medical researchers, and regulatory personnel in drug development, as well as graduate students in the health sciences. The authors’ decades of experience in the pharmaceutical industry and academia, and extensive regulatory experience, comes through in the many examples throughout the book.
Real World Evidence In A Patient Centric Digital Era
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Author : Kelly H. Zou
language : en
Publisher: CRC Press
Release Date : 2022-08-03
Real World Evidence In A Patient Centric Digital Era written by Kelly H. Zou and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-08-03 with Mathematics categories.
Real-world evidence is defined as evidence generated from real-world data outside randomized controlled trials. As scientific discoveries and methodologies continue to advance, real-world data and their companion technologies offer powerful new tools for evidence generation. Real-World Evidence in a Patient-Centric Digital Era provides perspectives, examples, and insights on the innovative application of real-world evidence to meet patient needs and improve healthcare, with a focus on the pharmaceutical industry. This book presents an overview of key analytical issues and best practices. Special attention is paid to the development, methodologies, and other salient features of the statistical and data science techniques that are customarily used to generate real-world evidence. It provides a review of key topics and emerging trends in cutting-edge data science and health innovation. Features: Provides an overview of statistical and analytic methodologies in real-world evidence to generate insights on healthcare, with a special focus on the pharmaceutical industry Examines timely topics of high relevance to industry such as bioethical considerations, regulatory standards, and compliance requirements Highlights emerging and current trends, and provides guidelines for best practices Illustrates methods through examples and use-case studies to demonstrate impact Provides guidance on software choices and digital applications for successful analytics Real-World Evidence in a Patient-Centric Digital Era will be a vital reference for medical researchers, health technology innovators, data scientists, epidemiologists, population health analysts, health economists, outcomes researchers, policymakers, and analysts in the healthcare industry.
Artificial Intelligence For Drug Development Precision Medicine And Healthcare
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Author : Mark Chang
language : en
Publisher: CRC Press
Release Date : 2020-05-12
Artificial Intelligence For Drug Development Precision Medicine And Healthcare 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 2020-05-12 with Business & Economics categories.
Artificial Intelligence for Drug Development, Precision Medicine, and Healthcare covers exciting developments at the intersection of computer science and statistics. While much of machine-learning is statistics-based, achievements in deep learning for image and language processing rely on computer science’s use of big data. Aimed at those with a statistical background who want to use their strengths in pursuing AI research, the book: · Covers broad AI topics in drug development, precision medicine, and healthcare. · Elaborates on supervised, unsupervised, reinforcement, and evolutionary learning methods. · Introduces the similarity principle and related AI methods for both big and small data problems. · Offers a balance of statistical and algorithm-based approaches to AI. · Provides examples and real-world applications with hands-on R code. · Suggests the path forward for AI in medicine and artificial general intelligence. As well as covering the history of AI and the innovative ideas, methodologies and software implementation of the field, the book offers a comprehensive review of AI applications in medical sciences. In addition, readers will benefit from hands on exercises, with included R code.
Analysis Of Incidence Rates
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Author : Peter Cummings
language : en
Publisher: CRC Press
Release Date : 2019-04-16
Analysis Of Incidence Rates written by Peter Cummings and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-04-16 with Mathematics categories.
Incidence rates are counts divided by person-time; mortality rates are a well-known example. Analysis of Incidence Rates offers a detailed discussion of the practical aspects of analyzing incidence rates. Important pitfalls and areas of controversy are discussed. The text is aimed at graduate students, researchers, and analysts in the disciplines of epidemiology, biostatistics, social sciences, economics, and psychology. Features: Compares and contrasts incidence rates with risks, odds, and hazards. Shows stratified methods, including standardization, inverse-variance weighting, and Mantel-Haenszel methods Describes Poisson regression methods for adjusted rate ratios and rate differences. Examines linear regression for rate differences with an emphasis on common problems. Gives methods for correcting confidence intervals. Illustrates problems related to collapsibility. Explores extensions of count models for rates, including negative binomial regression, methods for clustered data, and the analysis of longitudinal data. Also, reviews controversies and limitations. Presents matched cohort methods in detail. Gives marginal methods for converting adjusted rate ratios to rate differences, and vice versa. Demonstrates instrumental variable methods. Compares Poisson regression with the Cox proportional hazards model. Also, introduces Royston-Parmar models. All data and analyses are in online Stata files which readers can download. Peter Cummings is Professor Emeritus, Department of Epidemiology, School of Public Health, University of Washington, Seattle WA. His research was primarily in the field of injuries. He used matched cohort methods to estimate how the use of seat belts and presence of airbags were related to death in a traffic crash. He is author or co-author of over 100 peer-reviewed articles.
A Practical Approach To Quantitative Validation Of Patient Reported Outcomes
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Author : Andrew G. Bushmakin
language : en
Publisher: John Wiley & Sons
Release Date : 2022-10-31
A Practical Approach To Quantitative Validation Of Patient Reported Outcomes written by Andrew G. Bushmakin 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 2022-10-31 with Medical categories.
A Simulation-Based Guide Using SAS In A Practical Approach to Quantitative Validation of Patient-Reported Outcomes, two distinguished researchers, with 50 years of collective research experience and hundreds of publications on patient-centered research, deliver a detailed and comprehensive exposition on the critical steps required for quantitative validation of patient-reported outcomes (PROs). The book provides an incisive and instructional explanation and discussion on major aspects of psychometric validation methodology on PROs, especially relevant for medical applications sponsored by the pharmaceutical industry, where SAS is the primary software, and evaluated in regulatory and other healthcare environments. Central topics include test-retest reliability, exploratory and confirmatory factor analyses, construct and criterion validity, responsiveness and sensitivity, interpretation of PRO scores and findings, and meaningful within-patient change and clinical important difference. The authors provide step-by-step guidance while walking readers through how to structure data prior to a PRO analysis and demonstrate how to implement analyses with simulated examples grounded in real-life scenarios. Readers will also find: A thorough introduction to patient-reported outcomes, including their definition, development, and psychometric validation Comprehensive explorations of the validation workflow, including discussions of clinical trials as a data source for validation and the validation workflow for single and multi-item scales In-depth discussions of key concepts related to a validation of a measurement scale Special attention is given to the US Food and Drug Administration (FDA) guidance on development and validation of the PROs, which lay the foundation and inspiration for the analytic methods executed A Practical Approach to Quantitative Validation of Patient-Reported Outcomes is a required reference that will benefit psychometricians, statisticians, biostatisticians, epidemiologists, health service and public health researchers, outcome research scientists, regulators, and payers. STATISTICS IN PRACTICE A series of practical books outlining the use of statistical techniques in a wide range of applications areas: HUMAN AND BIOLOGICAL SCIENCES EARTH AND ENVIRONMENTAL SCIENCES INDUSTRY, COMMERCE AND FINANCE
Self Controlled Case Series Studies
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Author : Paddy Farrington
language : en
Publisher: CRC Press
Release Date : 2018-05-03
Self Controlled Case Series Studies written by Paddy Farrington and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-05-03 with Mathematics categories.
Self-Controlled Case Series Studies: A Modelling Guide with R provides the first comprehensive account of the self-controlled case series (SCCS) method, a statistical technique for investigating associations between outcome events and time-varying exposures. The method only requires information from individuals who have experienced the event of interest, and automatically controls for multiplicative time-invariant confounders, even when these are unmeasured or unknown. It is increasingly being used in epidemiology, most frequently to study the safety of vaccines and pharmaceutical drugs. Key features of the book include: A thorough yet accessible description of the SCCS method, with mathematical details provided in separate starred sections. Comprehensive discussion of assumptions and how they may be verified. A detailed account of different SCCS models, extensions of the SCCS method, and the design of SCCS studies. Extensive practical illustrations and worked examples from epidemiology. Full computer code from the associated R package SCCS, which includes all the data sets used in the book. The book is aimed at a broad range of readers, including epidemiologists and medical statisticians who wish to use the SCCS method, and also researchers with an interest in statistical methodology. The three authors have been closely involved with the inception, development, popularisation and programming of the SCCS method.
Innovative Methods For Rare Disease Drug Development
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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 2020-11-11
Innovative Methods For Rare Disease Drug Development written by Shein-Chung Chow and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-11-11 with Mathematics categories.
In the United States, a rare disease is defined by the Orphan Drug Act as a disorder or condition that affects fewer than 200,000 persons. For the approval of "orphan" drug products for rare diseases, the traditional approach of power analysis for sample size calculation is not feasible because there are only limited number of subjects available for clinical trials. In this case, innovative approaches are needed for providing substantial evidence meeting the same standards for statistical assurance as drugs used to treat common conditions. Innovative Methods for Rare Disease Drug Development focuses on biostatistical applications in terms of design and analysis in pharmaceutical research and development from both regulatory and scientific (statistical) perspectives. Key Features: Reviews critical issues (e.g., endpoint/margin selection, sample size requirements, and complex innovative design). Provides better understanding of statistical concepts and methods which may be used in regulatory review and approval. Clarifies controversial statistical issues in regulatory review and approval accurately and reliably. Makes recommendations to evaluate rare diseases regulatory submissions. Proposes innovative study designs and statistical methods for rare diseases drug development, including n-of-1 trial design, adaptive trial design, and master protocols like platform trials. Provides insight regarding current regulatory guidance on rare diseases drug development like gene therapy.
Key Topics In Surgical Research And Methodology
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Author : Thanos Athanasiou
language : en
Publisher: Springer Science & Business Media
Release Date : 2010-02-28
Key Topics In Surgical Research And Methodology written by Thanos Athanasiou and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-02-28 with Medical categories.
Key Topics in Surgical Research and Methodology represents a comprehensive reference text accessible to the surgeon embarking on an academic career. Key themes emphasize and summarize the text. Four key elements are covered, i.e. Surgical Research, Research Methodology, Practical Problems and Solutions on Research as well as Recent Developments and Future Prospects in Surgical Research and Practice.
Biostatistics In Biopharmaceutical Research And Development
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Author : Ding-Geng Chen
language : en
Publisher: Springer Nature
Release Date : 2024-12-24
Biostatistics In Biopharmaceutical Research And Development written by Ding-Geng Chen and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-12-24 with Mathematics categories.
The Deming Conference on Applied Statistics has long been deemed an influential event in the biostatistics and biopharmaceutical profession. It provides learning experience on recent developments in statistical methodologies in biopharmaceutical applications and FDA regulations. This book honors 80 years of contributions and dedication of the Deming Conference in biostatistics, and biopharmaceutical clinical trial methodology and applications. All chapters are contributed by world-class and prominent Deming speakers, who've contributed their cutting-edge research and developments to the community. Volume 2 covers Biomarkers in Drug Development, Time-To-Event Data Analysis and Methods, and emerging development in biopharmaceutical biostatistics. This book aims to booster research, education, and training in biostatistics and in biopharmaceutical research and development.