Real World Evidence In A Patient Centric Digital Era

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Real-World Evidence in a Patient-Centric Digital Era

Author : Kelly H. Zou
Publisher : CRC Press
ISBN 13 : 1000613453
Total Pages : 155 pages
Book Rating : 4.0/5 (6 download)

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Book Synopsis Real-World Evidence in a Patient-Centric Digital Era by : Kelly H. Zou

Download or read book Real-World Evidence in a Patient-Centric Digital Era written by Kelly H. Zou and published by CRC Press. This book was released on 2022-08-03 with total page 155 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The Practice of Patient Centered Care: Empowering and Engaging Patients in the Digital Era

Author : R. Engelbrecht
Publisher : IOS Press
ISBN 13 : 1614998248
Total Pages : 132 pages
Book Rating : 4.6/5 (149 download)

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Book Synopsis The Practice of Patient Centered Care: Empowering and Engaging Patients in the Digital Era by : R. Engelbrecht

Download or read book The Practice of Patient Centered Care: Empowering and Engaging Patients in the Digital Era written by R. Engelbrecht and published by IOS Press. This book was released on 2017-11-16 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical informatics is increasingly central to the effective and efficient delivery of healthcare today. This book presents the proceedings of the European Federation for Medical Informatics Special Topic Conference (EFMI STC 2017), held in Tel Aviv, Israel, in October 2017. The theme and title of the 2017 edition of this annual conference is ‘The practice of patient centered care: Empowering and engaging patients in the digital era’. The aim of the conference series is to increase interaction and collaboration between the stakeholder groups from both health and ICT across, but not limited to, Europe by providing a platform for researchers, data scientists, practitioners, decision makers and entrepreneurs to discuss sustainable and inclusive digital health innovations aimed at the engagement and empowerment of patients/consumers. The book is divided into 3 sections: full papers, short communications, and posters, and covers a wide range of topics from the field of medical informatics. It will be of interest to healthcare planners and providers everywhere.

Registries for Evaluating Patient Outcomes

Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 385 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Digital Therapeutics

Author : Oleksandr Sverdlov
Publisher : CRC Press
ISBN 13 : 1000799239
Total Pages : 462 pages
Book Rating : 4.0/5 (7 download)

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Book Synopsis Digital Therapeutics by : Oleksandr Sverdlov

Download or read book Digital Therapeutics written by Oleksandr Sverdlov and published by CRC Press. This book was released on 2022-12-06 with total page 462 pages. Available in PDF, EPUB and Kindle. Book excerpt: One of the hallmarks of the 21st century medicine is the emergence of digital therapeutics (DTx)—evidence-based, clinically validated digital technologies to prevent, diagnose, treat, and manage various diseases and medical conditions. DTx solutions have been gaining interest from patients, investors, healthcare providers, health authorities, and other stakeholders because of the potential of DTx to deliver equitable, massively scalable, personalized and transformative treatments for different unmet medical needs. Digital Therapeutics: Scientific, Statistical, Clinical, and Regulatory Aspects is an unparalleled summary of the current scientific, statistical, developmental, and regulatory aspects of DTx which is poised to become the fastest growing area of the biopharmaceutical and digital medicine product development. This edited volume intends to provide a systematic exposition to digital therapeutics through 19 peer-reviewed chapters written by subject matter experts in this emerging field. This edited volume is an invaluable resource for business leaders and researchers working in public health, healthcare, digital health, information technology, and biopharmaceutical industries. It will be also useful for regulatory scientists involved in the review of DTx products, and for faculty and students involved in an interdisciplinary research on digital health and digital medicine. Key Features: Provides the taxonomy of the concepts and a navigation tool for the field of DTx. Covers important strategic aspects of the DTx industry, thereby helping investors, developers, and regulators gain a better appreciation of the potential value of DTx. Expounds on many existing and emerging state-of-the art scientific and technological tools, as well as data privacy, ethical and regulatory considerations for DTx product development. Presents several case studies of successful development of some of the most remarkable DTx products. Provides some perspectives and forward-looking statements on the future of digital medicine.

Statistical Analytics for Health Data Science with SAS and R

Author : Jeffrey Wilson
Publisher : CRC Press
ISBN 13 : 1000848825
Total Pages : 280 pages
Book Rating : 4.0/5 (8 download)

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Book Synopsis Statistical Analytics for Health Data Science with SAS and R by : Jeffrey Wilson

Download or read book Statistical Analytics for Health Data Science with SAS and R written by Jeffrey Wilson and published by CRC Press. This book was released on 2023-03-27 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book aims to compile typical fundamental-to-advanced statistical methods to be used for health data sciences. Although the book promotes applications to health and health-related data, the models in the book can be used to analyze any kind of data. The data are analyzed with the commonly used statistical software of R/SAS (with online supplementary on SPSS/Stata). The data and computing programs will be available to facilitate readers’ learning experience. There has been considerable attention to making statistical methods and analytics available to health data science researchers and students. This book brings it all together to provide a concise point-of-reference for the most commonly used statistical methods from the fundamental level to the advanced level. We envisage this book will contribute to the rapid development in health data science. We provide straightforward explanations of the collected statistical theory and models, compilations of a variety of publicly available data, and illustrations of data analytics using commonly used statistical software of SAS/R. We will have the data and computer programs available for readers to replicate and implement the new methods. The primary readers would be applied data scientists and practitioners in any field of data science, applied statistical analysts and scientists in public health, academic researchers, and graduate students in statistics and biostatistics. The secondary readers would be R&D professionals/practitioners in industry and governmental agencies. This book can be used for both teaching and applied research.

Data Science, AI, and Machine Learning in Drug Development

Author : Harry Yang
Publisher : CRC Press
ISBN 13 : 100065267X
Total Pages : 335 pages
Book Rating : 4.0/5 (6 download)

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Book Synopsis Data Science, AI, and Machine Learning in Drug Development by : Harry Yang

Download or read book Data Science, AI, and Machine Learning in Drug Development written by Harry Yang and published by CRC Press. This book was released on 2022-10-04 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: The confluence of big data, artificial intelligence (AI), and machine learning (ML) has led to a paradigm shift in how innovative medicines are developed and healthcare delivered. To fully capitalize on these technological advances, it is essential to systematically harness data from diverse sources and leverage digital technologies and advanced analytics to enable data-driven decisions. Data science stands at a unique moment of opportunity to lead such a transformative change. Intended to be a single source of information, Data Science, AI, and Machine Learning in Drug Research and Development covers a wide range of topics on the changing landscape of drug R & D, emerging applications of big data, AI and ML in drug development, and the build of robust data science organizations to drive biopharmaceutical digital transformations. Features Provides a comprehensive review of challenges and opportunities as related to the applications of big data, AI, and ML in the entire spectrum of drug R & D Discusses regulatory developments in leveraging big data and advanced analytics in drug review and approval Offers a balanced approach to data science organization build Presents real-world examples of AI-powered solutions to a host of issues in the lifecycle of drug development Affords sufficient context for each problem and provides a detailed description of solutions suitable for practitioners with limited data science expertise

Value of Information for Healthcare Decision-Making

Author : Anna Heath
Publisher : CRC Press
ISBN 13 : 1003825575
Total Pages : 317 pages
Book Rating : 4.0/5 (38 download)

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Book Synopsis Value of Information for Healthcare Decision-Making by : Anna Heath

Download or read book Value of Information for Healthcare Decision-Making written by Anna Heath and published by CRC Press. This book was released on 2024-02-08 with total page 317 pages. Available in PDF, EPUB and Kindle. Book excerpt: Value of Information for Healthcare Decision-Making introduces the concept of Value of Information (VOI) use in health policy decision-making to determine the sensitivity of decisions to assumptions, and to prioritise and design future research. These methods, and their use in cost-effectiveness analysis, are increasingly acknowledged by health technology assessment authorities as vital. Key Features: Provides a comprehensive overview of VOI Simplifies VOI Showcases state-of-the-art techniques for computing VOI Includes R statistical software package Provides results when using VOI methods Uses realistic decision model to illustrate key concepts The primary audience for this book is health economic modellers and researchers, in industry, government, or academia, who wish to perform VOI analysis in health economic evaluations. It is relevant for postgraduate researchers and students in health economics or medical statistics who are required to learn the principles of VOI or undertake VOI analyses in their projects. The overall goal is to improve the understanding of these methods and make them easier to use.

Case Studies in Innovative Clinical Trials

Author : Kristine Broglio
Publisher : CRC Press
ISBN 13 : 1000987213
Total Pages : 303 pages
Book Rating : 4.0/5 (9 download)

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Book Synopsis Case Studies in Innovative Clinical Trials by : Kristine Broglio

Download or read book Case Studies in Innovative Clinical Trials written by Kristine Broglio and published by CRC Press. This book was released on 2023-11-27 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug development is a strictly regulated area. As such, marketing approval of a new drug depends heavily, if not exclusively, on evidence generated from clinical trials. Drug development has seen tremendous innovation in science and technology that has revolutionized the treatment of some diseases. And yet, the statistical design and practical conduct of the clinical trials used to test new therapeutics for safety and efficacy have changed very little over the decades. Our approach to clinical trials is steeped in convention and tradition. The large, fixed, randomized controlled trial methods that have been the gold standard are well understood and expected by many trial stakeholders. However, this approach is not well suited to all aspects of modern drug development and the current competitive landscape. We now see new therapies that target a small fraction of the patient population, rare diseases with high unmet medical needs, and pediatric populations that must wait for years for new drug approvals from the time that therapies are approved in adults. Large randomized clinical trials are at best inefficient and at worst completely infeasible in many modern clinical settings. Advances in technology and data infrastructure call for innovations in clinical trial design. Despite advances in statistical methods, the availability of information, and computing power, the actual experience with innovative design in clinical trials across industry and academia is limited. This book will be an important showcase of the potential for these innovative designs in modern drug development and will be an important resource to guide those who wish to undertake them for themselves. This book is ideal for professionals in the pharmaceutical industry and regulatory agencies, but it will also be useful to academic researchers, faculty members, and graduate students in statistics, biostatistics, public health, and epidemiology due to its focus on innovation. Key Features: Is written by pharmaceutical industry experts, academic researchers, and regulatory reviewers; this is the first book providing a comprehensive set of case studies related to statistical methodology, implementation, regulatory considerations, and communication of complex innovative trial design Has a broad appeal to a multitude of readers across academia, industry, and regulatory agencies Each contribution is a practical case study that can speak to the benefits of an innovative approach but also balance that with the real-life challenges encountered A complete understanding of what is actually being done in modern clinical trials will broaden the reader’s capabilities and provide examples to first mimic and then customize and expand upon when exploring these ideas on their own

Case Studies in Bayesian Methods for Biopharmaceutical CMC

Author : Paul Faya
Publisher : CRC Press
ISBN 13 : 1000824861
Total Pages : 423 pages
Book Rating : 4.0/5 (8 download)

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Book Synopsis Case Studies in Bayesian Methods for Biopharmaceutical CMC by : Paul Faya

Download or read book Case Studies in Bayesian Methods for Biopharmaceutical CMC written by Paul Faya and published by CRC Press. This book was released on 2022-12-15 with total page 423 pages. Available in PDF, EPUB and Kindle. Book excerpt: The subject of this book is applied Bayesian methods for chemistry, manufacturing, and control (CMC) studies in the biopharmaceutical industry. The book has multiple authors from industry and academia, each contributing a case study (chapter). The collection of case studies covers a broad array of CMC topics, including stability analysis, analytical method development, specification setting, process development and optimization, process control, experimental design, dissolution testing, and comparability studies. The analysis of each case study includes a presentation of code and reproducible output. This book is written with an academic level aimed at practicing nonclinical biostatisticians, most of whom have graduate degrees in statistics. • First book of its kind focusing strictly on CMC Bayesian case studies • Case studies with code and output • Representation from several companies across the industry as well as academia • Authors are leading and well-known Bayesian statisticians in the CMC field • Accompanying website with code for reproducibility • Reflective of real-life industry applications/problems

Design and Analysis of Pragmatic Trials

Author : Song Zhang
Publisher : CRC Press
ISBN 13 : 1000873552
Total Pages : 215 pages
Book Rating : 4.0/5 (8 download)

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Book Synopsis Design and Analysis of Pragmatic Trials by : Song Zhang

Download or read book Design and Analysis of Pragmatic Trials written by Song Zhang and published by CRC Press. This book was released on 2023-05-16 with total page 215 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book begins with an introduction of pragmatic cluster randomized trials (PCTs) and reviews various pragmatic issues that need to be addressed by statisticians at the design stage. It discusses the advantages and disadvantages of each type of PCT, and provides sample size formulas, sensitivity analyses, and examples for sample size calculation. The generalized estimating equation (GEE) method will be employed to derive sample size formulas for various types of outcomes from the exponential family, including continuous, binary, and count variables. Experimental designs that have been frequently employed in PCTs will be discussed, including cluster randomized designs, matched-pair cluster randomized design, stratified cluster randomized design, stepped-wedge cluster randomized design, longitudinal cluster randomized design, and crossover cluster randomized design. It demonstrates that the GEE approach is flexible to accommodate pragmatic issues such as hierarchical correlation structures, different missing data patterns, randomly varying cluster sizes, etc. It has been reported that the GEE approach leads to under-estimated variance with limited numbers of clusters. The remedy for this limitation is investigated for the design of PCTs. This book can assist practitioners in the design of PCTs by providing a description of the advantages and disadvantages of various PCTs and sample size formulas that address various pragmatic issues, facilitating the proper implementation of PCTs to improve health care. It can also serve as a textbook for biostatistics students at the graduate level to enhance their knowledge or skill in clinical trial design. Key Features: Discuss the advantages and disadvantages of each type of PCTs, and provide sample size formulas, sensitivity analyses, and examples. Address an unmet need for guidance books on sample size calculations for PCTs; A wide variety of experimental designs adopted by PCTs are covered; The sample size solutions can be readily implemented due to the accommodation of common pragmatic issues encountered in real-world practice; Useful to both academic and industrial biostatisticians involved in clinical trial design; Can be used as a textbook for graduate students majoring in statistics and biostatistics.

ROC Analysis for Classification and Prediction in Practice

Author : Christos Nakas
Publisher : CRC Press
ISBN 13 : 1482233711
Total Pages : 234 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis ROC Analysis for Classification and Prediction in Practice by : Christos Nakas

Download or read book ROC Analysis for Classification and Prediction in Practice written by Christos Nakas and published by CRC Press. This book was released on 2023-05-15 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents a unified and up-to-date introduction to ROC methodologies, covering both diagnosis (classification) and prediction. The emphasis is on the conceptual underpinning of ROC analysis and the practical implementation in diverse scientific fields. A plethora of examples accompany the methodologic discussion using standard statistical software such as R and STATA. The book arrives after two decades of intensive growth in both the methods and the applications of ROC analysis and presents a new synthesis. The authors provide a contemporary, integrated exposition of ROC methodology for both classification and prediction and include material on multiple-class ROC. This book avoids lengthy technical exposition and provides code and datasets in each chapter. Receiver Operating Characteristic Analysis for Classification and Prediction is intended for researchers and graduate students, but will also be useful for those that use ROC analysis in diverse disciplines such as diagnostic medicine, bioinformatics, medical physics, and perception psychology.

Controlled Epidemiological Studies

Author : Marie Reilly
Publisher : CRC Press
ISBN 13 : 0429588801
Total Pages : 436 pages
Book Rating : 4.4/5 (295 download)

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Book Synopsis Controlled Epidemiological Studies by : Marie Reilly

Download or read book Controlled Epidemiological Studies written by Marie Reilly and published by CRC Press. This book was released on 2023-05-26 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers classic epidemiological designs that use a reference/control group, including case-control, case-cohort, nested case-control and variations of these designs, such as stratified and two-stage designs. It presents a unified view of these sampling designs as representations of an underlying cohort or target population of interest. This enables various extended designs to be introduced and analysed with a similar approach: extreme sampling on the outcome (extreme case-control design) or on the exposure (exposure-enriched, exposure-density, countermatched), designs that re-use prior controls and augmentation sampling designs. Further extensions exploit aggregate data for efficient cluster sampling, accommodate time-varying exposures and combine matched and unmatched controls. Self-controlled designs, including case-crossover, self-controlled case series and exposure-crossover, are also presented. The test-negative design for vaccine studies and the use of negative controls for bias assessment are introduced and discussed. This book is intended for graduate students in biostatistics, epidemiology and related disciplines, or for health researchers and data analysts interested in extending their knowledge of study design and data analysis skills. This book Bridges the gap between epidemiology and the more mathematically oriented biostatistics books. Assembles the wealth of epidemiological knowledge about observational study designs that is scattered over several decades of scientific publications. Illustrates the performance of methods in real research applications. Provides guidelines for implementation in standard software packages (Stata, R). Includes numerous exercises, covering simple mathematical proofs, consideration of proposed or published designs, and practical data analysis.

Drug Development for Rare Diseases

Author : Bo Yang
Publisher : CRC Press
ISBN 13 : 100082022X
Total Pages : 233 pages
Book Rating : 4.0/5 (8 download)

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Book Synopsis Drug Development for Rare Diseases by : Bo Yang

Download or read book Drug Development for Rare Diseases written by Bo Yang and published by CRC Press. This book was released on 2023-01-10 with total page 233 pages. Available in PDF, EPUB and Kindle. Book excerpt: A disease is defined as rare if the prevalence is fewer than 200,000 in the United States. It is estimated that there are more than 7,000 rare diseases, which collectively affect 30 million Americans or 10% of the US population. This diverse and complex disease area poses challenges for patients, caregivers, regulators, drug developers, and other stakeholders. This book is proposed to give an overview of the common issues facing rare disease drug developers, summarize challenges specific to clinical development in small populations, discuss drug development strategies in the evolving regulatory environment, explain generation and utilization of different data and evidence inside and beyond clinical trials, and use recent examples to demonstrate these challenges and the development strategies that respond to the challenges. Key Features: • Rare disease. • Drug development. • Innovative clinical trial design. • Regulatory approval. • Real-world evidence.

Quantitative Methods for Precision Medicine

Author : Rongling Wu
Publisher : CRC Press
ISBN 13 : 1482219468
Total Pages : 307 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis Quantitative Methods for Precision Medicine by : Rongling Wu

Download or read book Quantitative Methods for Precision Medicine written by Rongling Wu and published by CRC Press. This book was released on 2022-12-26 with total page 307 pages. Available in PDF, EPUB and Kindle. Book excerpt: Modern medicine is undergoing a paradigm shift from a "one-size-fits-all" strategy to a more precise patient-customized therapy and medication plan. While the success of precision medicine relies on the level of pharmacogenomic knowledge, dissecting the genetic mechanisms of drug response in a sufficient detail requires powerful computational tools. Quantitative Methods for Precision Medicine: Pharmacogenomics in Action presents the advanced statistical methods for mapping pharmacogenetic control by integrating pharmacokinetic and pharmacodynamic principles of drug-body interactions. Beyond traditional reductionist-based statistical genetic approaches, statistical formulization in this book synthesizes elements of multiple disciplines to infer, visualize, and track how pharmacogenes interact together as an intricate but well-coordinated system to mediate patient-specific drug response. Features: Functional and systems mapping models to characterize the genetic architecture of multiple medication processes Statistical methods for analyzing informative missing data in pharmacogenetic association studies Functional graph theory of inferring genetic interaction networks from association data Leveraging the concept of epistasis to capture its bidirectional, signed and weighted properties Modeling gene-induced cell-cell crosstalk and its impact on drug response A graph model of drug-drug interactions in combination therapies Critical methodological issues to improve pharmacogenomic research as the cornerstone of precision medicine This book is suitable for graduate students and researchers in the fields of biology, medicine, bioinformatics and drug design and delivery who are interested in statistical and computational modelling of biological processes and systems. It may also serve as a major reference for applied mathematicians, computer scientists, and statisticians who attempt to develop algorithmic tools for genetic mapping, systems pharmacogenomics and systems biology. It can be used as both a textbook and research reference. Professionals in pharmaceutical sectors who design drugs and clinical doctors who deliver drugs will also find it useful.

Model-Assisted Bayesian Designs for Dose Finding and Optimization

Author : Ying Yuan
Publisher : CRC Press
ISBN 13 : 0429628471
Total Pages : 234 pages
Book Rating : 4.4/5 (296 download)

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Book Synopsis Model-Assisted Bayesian Designs for Dose Finding and Optimization by : Ying Yuan

Download or read book Model-Assisted Bayesian Designs for Dose Finding and Optimization written by Ying Yuan and published by CRC Press. This book was released on 2022-11-11 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bayesian adaptive designs provide a critical approach to improve the efficiency and success of drug development that has been embraced by the US Food and Drug Administration (FDA). This is particularly important for early phase trials as they form the basis for the development and success of subsequent phase II and III trials. The objective of this book is to describe the state-of-the-art model-assisted designs to facilitate and accelerate the use of novel adaptive designs for early phase clinical trials. Model-assisted designs possess avant-garde features where superiority meets simplicity. Model-assisted designs enjoy exceptional performance comparable to more complicated model-based adaptive designs, yet their decision rules often can be pre-tabulated and included in the protocol—making implementation as simple as conventional algorithm-based designs. An example is the Bayesian optimal interval (BOIN) design, the first dose-finding design to receive the fit-for-purpose designation from the FDA. This designation underscores the regulatory agency's support of the use of the novel adaptive design to improve drug development. Features Represents the first book to provide comprehensive coverage of model-assisted designs for various types of dose-finding and optimization clinical trials Describes the up-to-date theory and practice for model-assisted designs Presents many practical challenges, issues, and solutions arising from early-phase clinical trials Illustrates with many real trial applications Offers numerous tips and guidance on designing dose finding and optimization trials Provides step-by-step illustrations of using software to design trials Develops a companion website (www.trialdesign.org) to provide freely available, easy-to-use software to assist learning and implementing model-assisted designs Written by internationally recognized research leaders who pioneered model-assisted designs from the University of Texas MD Anderson Cancer Center, this book shows how model-assisted designs can greatly improve the efficiency and simplify the design, conduct, and optimization of early-phase dose-finding trials. It should therefore be a very useful practical reference for biostatisticians, clinicians working in clinical trials, and drug regulatory professionals, as well as graduate students of biostatistics. Novel model-assisted designs showcase the new KISS principle: Keep it simple and smart!

The Digital Transformation of the Healthcare System

Author : Katarzyna Kolasa
Publisher : Taylor & Francis
ISBN 13 : 1000820157
Total Pages : 117 pages
Book Rating : 4.0/5 (8 download)

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Book Synopsis The Digital Transformation of the Healthcare System by : Katarzyna Kolasa

Download or read book The Digital Transformation of the Healthcare System written by Katarzyna Kolasa and published by Taylor & Francis. This book was released on 2023-07-31 with total page 117 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines how the digital revolution has reorganized the model of healthcare during the COVID-19 pandemic and argues for a continued paradigm shift to digital healthcare. Katarzyna Kolasa sets the vision of healthcare 5.0 that relieves the burden on limited healthcare resources and creates better health outcomes by switching the focus from treatment to prediction and prevention. She advocates for a patient-centric ecosystem that empowers patients to take control of their health via new knowledge-based technologies such as next-generation sequencing (NGS), nanotechnology, artificial intelligence and digital therapeutics. Highlighting the mindset shift needed to transform healthcare and outlining in detail a futuristic vision of healthcare 5.0, this book will be of interest to academics and professionals of health policy, health economics and digital health.

Digital Identity in the New Era of Personalized Medicine

Author : Vasiliu-Feltes, Ingrid
Publisher : IGI Global
ISBN 13 : 179988967X
Total Pages : 290 pages
Book Rating : 4.7/5 (998 download)

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Book Synopsis Digital Identity in the New Era of Personalized Medicine by : Vasiliu-Feltes, Ingrid

Download or read book Digital Identity in the New Era of Personalized Medicine written by Vasiliu-Feltes, Ingrid and published by IGI Global. This book was released on 2022-11-18 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: Within the past decade, we have witnessed an increased adoption of emerging technologies as well as the exponential pace of scientific discoveries within all industries. The level of digital innovation and digital transformation experienced in healthcare and life sciences has been markedly accelerated by the COVID-19 pandemic. There is a new sense of urgency to design and develop a new global health ecosystem that is more suitable for the digital era and future generations. Deploying precision medicine solutions that can redefine the way we diagnose and treat disease, as well as shift the focus towards a customized human-centered approach, such as those offered by personalized medicine, can be a viable sustainable model. Digital Identity in the New Era of Personalized Medicine highlights the latest trends in precision medicine and the important role digital identity plays in upholding ethical values, safeguarding human rights, and practicing responsible personalized medicine. It provides an overview of the current healthcare legal and regulatory landscapes as well as some of the major challenges and opportunities we face in this digital, virtual, and precision medicine-powered era. Covering topics such as data-centric compliance, global health, and identity management, this book is an essential resource for doctors, healthcare administration, academicians, clinicians, health and bio-tech executives, researchers, medical professionals, medical engineers, medical students, and government officials looking for a resource that addresses challenges in healthcare including trust, privacy, data integrity, and ownership.