Advertisement
| decentralized clinical trials technology: Virtual Clinical Trials National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2019-11-16 Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop. |
| decentralized clinical trials technology: Fundamentals of Decentralized Clinical Trials Anna Yang, Isaac R Rodriguez-Chavez, 2024-08-11 A timely and first-of-its-kind publication in the field, this short handbook on decentralized clinical trials (DCTs) offers a thorough exploration of the potential of DCTs to revolutionize clinical research through innovative approaches, including technology. This concise and easy-to-read publication is especially designed for those who seek to understand and get up-to-speed on what DCTs mean and how to work in this rapidly evolving field. As discussed in Chapter 1, DCTs address barriers to traditional trial participation, promoting accessibility, diversity, equity, and participant engagement. Chapter 2 examines how the COVID-19 pandemic and evolving regulations accelerated the adoption of DCTs, building on their application since the early 2000s. Chapters 3 and 4 highlight remaining operational complexities and the importance of careful trial design to ensure scientific rigor, operational feasibility, and compliance with regulations, ethics, data privacy, and participant safety. The book emphasizes the significance of the FDA's draft guidance on DCTs, detailing investigator responsibilities, local health care providers' use, and essential sponsor considerations. Chapter 5 stresses the need for clear metrics to evaluate DCT adoption's impact on recruitment, retention, diversity, safety, and cost efficiencies. Overall, this guide tracks DCT advancements and encourages readers to contribute to evidence-based integration, meeting participant expectations for convenience and fostering faster, more inclusive clinical studies. Ultimately, this book aims to support the transformation of modern clinical research, developing medical products more efficiently for those in need. A major contribution to the literature on clinical research, this work will be a resourceful tool to anyone interested in embracing decentralized clinical research and improving access and participation for all. |
| decentralized clinical trials technology: Political and Economic Implications of Blockchain Technology in Business and Healthcare Rodrigues, Dário de Oliveira, 2021-06-11 Besides love, money and health are the most valuable human yearnings. Therefore, blockchain technology is paramount: a new foundation of confidence for human valuable transactions. Like information sharing was catalyzed on the pre-blockchain internet, transactions are now triggered on the new internet of value. In this second digital inflection point, economic media encompasses value beside information, and individuals can privately transact digital assets for the first time in history. Decentralized but structured organizations running on blockchain networks reduce transaction costs and are particularly competitive insofar as they guarantee data authenticity, confidentiality, and integrity, providing functional autonomy with disintermediation and smart contracts. Everything changed after user data were made public on the internet and privately traded by big tech companies, and nothing will be the same once that data is made private on the internet and publicly transacted by their rightful owners. While the internet of information reshaped the world, the internet of value will reform it, and everything will depend politically on this being done freely. Political and Economic Implications of Blockchain Technology in Business and Healthcare provides relevant theoretical frameworks on the civilizational impact of blockchain technology, which redesigns human interactions concerning value transactions. It gives ideas, concepts, and instruments to advance the knowledge on cryptoeconomics and decentralized governance in the new distributed trust paradigm. The chapters explore the ethical repercussions and profound political-economic consequences to society, providing insights into business applications focusing on the healthcare sector. In a blockchain era affected by the post-COVID-19 new normal, which mixes politics, economics, and health, this book is essential for students and researchers in social and life sciences; professionals and policymakers working in the fields of public and business administration; and healthcare workers and researchers, academicians, and students interested in blockchain technology and its political and economic impacts in the industry and society. |
| decentralized clinical trials technology: Modern Methods of Clinical Investigation Institute of Medicine, Committee on Technological Innovation in Medicine, 1990-02-01 The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians. |
| decentralized clinical trials technology: Innovation in Clinical Trial Methodologies Peter Schueler, 2020-11-20 Innovation in Clinical Trial Methodologies: Lessons Learned during the Corona Pandemic presents a selection of updated chapters from Re-Engineering Clinical Trials that feature innovative options and methods in clinical trials. The Coronavirus pandemic is an accelerator for digitalization in many industries, including clinical trials. This book considers best practices, alternative study concepts requiring fewer patients, studies with less patient interaction, the design of virtualized protocols, and moving from data to decisions. This book will be helpful to pharmacologists, physicians and clinical researchers involved in the process of clinical development and clinical trial design. Considers multiple digital and virtual strategies Explores best practices, including the use of reduced patient involvement Brings together expert, trusted information to increase the efficiency and effectiveness of clinical trials |
| decentralized clinical trials technology: Fundamentals of Decentralized Clinical Trials Anna H. Yang, |
| decentralized clinical trials technology: Opportunities and Challenges for Blockchain Technology in Autonomous Vehicles Amit Kumar Tyagi, Gillala Rekha, N. Sreenath, 2020 This book examines the applications, approaches, and challenges to using blockchain technology in autonomous vehicles-- |
| decentralized clinical trials technology: Oxford Textbook of Pediatric Pain Bonnie J. Stevens, Gareth Hathway, William T. Zempsky, 2021 The oxford textbook of paediatric pain brings together clinicians, educators, trainees and researchers to provide an authoritative resource on all aspects of pain in infants, children and youth. |
| decentralized clinical trials technology: Fundamentals of Decentralized Clinical Trials Anna H. Yang, Isaac R. Rodriguez-Chavez, 2024-11-16 |
| decentralized clinical trials technology: Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade World Intellectual Property Organization, 2013 This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies. |
| decentralized clinical trials technology: Blockchain for Healthcare Systems Sheikh Mohammad Idrees, Parul Agarwal, M. Afshar Alam, 2021-09-21 Blockchain for Healthcare Systems: Challenges, Privacy, and Securing of Data provides a detailed insight on how to reap the benefits of blockchain technology in healthcare, as the healthcare sector faces several challenges associated with privacy and security issues. It also provides in-depth knowledge regarding blockchain in healthcare and the underlying components. This book explores securing healthcare data using blockchain technology. It discusses challenges and solutions for blockchain technology in the healthcare sector and presents the digital transformation of the healthcare sector using different technologies. It covers the handling of healthcare data/medical records and managing the medical supply chain all using blockchain technology. The contents of this book are highly beneficial to educators, researchers, and others working in a similar domain. |
| decentralized clinical trials technology: Applied Thematic Analysis Greg Guest, Kathleen M. MacQueen, Emily E. Namey, 2012 This book provides step-by-step instructions on how to analyze text generated from in-depth interviews and focus groups, relating predominantly to applied qualitative studies. The book covers all aspects of the qualitative data analysis process, employing a phenomenological approach which has a primary aim of describing the experiences and perceptions of research participants. Similar to Grounded Theory, the authors' approach is inductive, content-driven, and searches for themes within textual data. |
| decentralized clinical trials technology: Fast Facts: Digital Medicine - Measurement Andrea Coravos, Jennifer C. Goldsack, Daniel R. Karlin , Camille Nebeker, Eric Perakslis, Noah Zimmerman, M. Kelley Erb , 2020-03-31 Technology is changing how we practice medicine. Sensors and wearables are getting smaller and cheaper, and algorithms are becoming powerful enough to predict medical outcomes. Yet despite rapid advances, healthcare lags behind other industries in truly putting these technologies to use. A major barrier is the cross-disciplinary approach required to create digital tools, a process that requires knowledge from many people across a range of fields. 'Fast Facts: Digital Medicine – Measurement' aims to overcome that barrier, introducing the reader to core concepts and terms and facilitating dialogue. Contrasting 'clinical research' with routine 'clinical care', this short colorful book describes types of digital measurement and how to use and validate digital measures in different settings. And with the burgeoning development of digital medicine tools, the authors provide a timely overview of the security, ethical, regulatory and legal issues to be considered before a product can enter the market. Table of Contents: • What is digital medicine? • Where does digital medicine fit? • Regulatory considerations • Ethical principles and our responsibilities • Ethics in practice • Security, data rights and governance • Digital biomarkers and clinical outcomes • Measurement in clinical trials • Verification and validation • The future of digital medicine |
| decentralized clinical trials technology: Decentralized Computing Using Blockchain Technologies and Smart Contracts: Emerging Research and Opportunities Asharaf, S., Adarsh, S., 2017-01-31 Recent innovations have created significant developments in data storage and management. These new technologies now allow for greater security in databases and other applications. Decentralized Computing Using Blockchain Technologies and Smart Contracts: Emerging Research and Opportunities is a concise and informative source of academic research on the latest developments in block chain innovation and their application in contractual agreements. Highlighting pivotal discussions on topics such as cryptography, programming techniques, and decentralized computing, this book is an ideal publication for researchers, academics, professionals, students, and practitioners seeking content on utilizing block chains with smart contracts. |
| decentralized clinical trials technology: Rare Diseases and Orphan Products Institute of Medicine, Board on Health Sciences Policy, Committee on Accelerating Rare Diseases Research and Orphan Product Development, 2011-04-03 Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development. |
| decentralized clinical trials technology: Telemedicine Institute of Medicine, Committee on Evaluating Clinical Applications of Telemedicine, 1996-10-08 Telemedicineâ€the use of information and telecommunications technologies to provide and support health care when distance separates the participantsâ€is receiving increasing attention not only in remote areas where health care access is troublesome but also in urban and suburban locations. Yet the benefits and costs of this blend of medicine and digital technologies must be better demonstrated before today's cautious decision-makers invest significant funds in its development. Telemedicine presents a framework for evaluating patient care applications of telemedicine. The book identifies managerial, technical, policy, legal, and human factors that must be taken into account in evaluating a telemedicine program. The committee reviews previous efforts to establish evaluation frameworks and reports on results from several completed studies of image transmission, consulting from remote locations, and other telemedicine programs. The committee also examines basic elements of an evaluation and considers relevant issues of quality, accessibility, and cost of health care. Telemedicine will be of immediate interest to anyone with interest in the clinical application of telemedicine. |
| decentralized clinical trials technology: Sharing Clinical Trial Data Institute of Medicine, Board on Health Sciences Policy, Committee on Strategies for Responsible Sharing of Clinical Trial Data, 2015-04-20 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. |
| decentralized clinical trials technology: Clinical Trials in Oncology, Third Edition Stephanie Green, Jacqueline Benedetti, Angela Smith, John Crowley, 2012-05-09 The third edition of the bestselling Clinical Trials in Oncology provides a concise, nontechnical, and thoroughly up-to-date review of methods and issues related to cancer clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the pitfalls inherent in these processes. In addition, the book has been restructured to have separate chapters and expanded discussions on general clinical trials issues, and issues specific to Phases I, II, and III. New sections cover innovations in Phase I designs, randomized Phase II designs, and overcoming the challenges of array data. Although this book focuses on cancer trials, the same issues and concepts are important in any clinical setting. As always, the authors use clear, lucid prose and a multitude of real-world examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Armed with Clinical Trials in Oncology, Third Edition, clinicians and statisticians can avoid the many hazards that can jeopardize the success of a trial. |
| decentralized clinical trials technology: Fundamentals of Clinical Trials Lawrence M. Friedman, Curt Furberg, David L. DeMets, 1998 This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors. |
| decentralized clinical trials technology: Mathematical Modeling and Soft Computing in Epidemiology Jyoti Mishra, Ritu Agarwal, Abdon Atangana, 2020-12-28 This book describes the uses of different mathematical modeling and soft computing techniques used in epidemiology for experiential research in projects such as how infectious diseases progress to show the likely outcome of an epidemic, and to contribute to public health interventions. This book covers mathematical modeling and soft computing techniques used to study the spread of diseases, predict the future course of an outbreak, and evaluate epidemic control strategies. This book explores the applications covering numerical and analytical solutions, presents basic and advanced concepts for beginners and industry professionals, and incorporates the latest methodologies and challenges using mathematical modeling and soft computing techniques in epidemiology. Primary users of this book include researchers, academicians, postgraduate students, and specialists. |
| decentralized clinical trials technology: Artificial Intelligence in Healthcare Adam Bohr, Kaveh Memarzadeh, 2020-06-21 Artificial Intelligence (AI) in Healthcare is more than a comprehensive introduction to artificial intelligence as a tool in the generation and analysis of healthcare data. The book is split into two sections where the first section describes the current healthcare challenges and the rise of AI in this arena. The ten following chapters are written by specialists in each area, covering the whole healthcare ecosystem. First, the AI applications in drug design and drug development are presented followed by its applications in the field of cancer diagnostics, treatment and medical imaging. Subsequently, the application of AI in medical devices and surgery are covered as well as remote patient monitoring. Finally, the book dives into the topics of security, privacy, information sharing, health insurances and legal aspects of AI in healthcare. - Highlights different data techniques in healthcare data analysis, including machine learning and data mining - Illustrates different applications and challenges across the design, implementation and management of intelligent systems and healthcare data networks - Includes applications and case studies across all areas of AI in healthcare data |
| decentralized clinical trials technology: Virtual Clinical Trials National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2019-10-16 Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop. |
| decentralized clinical trials technology: Usability Evaluation In Industry Patrick W. Jordan, B. Thomas, Ian Lyall McClelland, Bernard Weerdmeester, 1996-06-11 This book provides a variety of answers in its description and discussion of new, sometimes radical approaches to `usability evaluation', now an increasingly common business tool. It contains new thinking of the subject of usability evaluation in industry. Contributions come from those involved in the practice of industry-based usability evaluation |
| decentralized clinical trials technology: The Gift of Participation Kenneth Getz, 2007 Kennth Getz takes a fresh look at why participation in clinical research really matters. This book addresses what clinical participation means and how it helps to advance medical science. Practical information on subjects like insurance coverage, compensation, and tax ramifications for clinical research volunteers also is included. With a foreword written by Congressman Rick Boucher of Virginia, and a back cover endorsement from Tour de France winner and cancer survivor Lance Armstrong, offers a road map into a world many readers are just beginning to explore. |
| decentralized clinical trials technology: Blockchain Technology: Platforms, Tools and Use Cases , 2018-08-21 Approx.278 pagesApprox.278 pages |
| decentralized clinical trials technology: Blockchain for Cybersecurity and Privacy Yassine Maleh, Mohammad Shojafar, Mamoun Alazab, Imed Romdhani, 2020-08-02 Blockchain technology is defined as a decentralized system of distributed registers that are used to record data transactions on multiple computers. The reason this technology has gained popularity is that you can put any digital asset or transaction in the blocking chain, the industry does not matter. Blockchain technology has infiltrated all areas of our lives, from manufacturing to healthcare and beyond. Cybersecurity is an industry that has been significantly affected by this technology and may be more so in the future. Blockchain for Cybersecurity and Privacy: Architectures, Challenges, and Applications is an invaluable resource to discover the blockchain applications for cybersecurity and privacy. The purpose of this book is to improve the awareness of readers about blockchain technology applications for cybersecurity and privacy. This book focuses on the fundamentals, architectures, and challenges of adopting blockchain for cybersecurity. Readers will discover different applications of blockchain for cybersecurity in IoT and healthcare. The book also includes some case studies of the blockchain for e-commerce online payment, retention payment system, and digital forensics. The book offers comprehensive coverage of the most essential topics, including: Blockchain architectures and challenges Blockchain threats and vulnerabilities Blockchain security and potential future use cases Blockchain for securing Internet of Things Blockchain for cybersecurity in healthcare Blockchain in facilitating payment system security and privacy This book comprises a number of state-of-the-art contributions from both scientists and practitioners working in the fields of blockchain technology and cybersecurity. It aspires to provide a relevant reference for students, researchers, engineers, and professionals working in this particular area or those interested in grasping its diverse facets and exploring the latest advances on the blockchain for cybersecurity and privacy. |
| decentralized clinical trials technology: Drug and Biological Development Ronald P. Evens, 2007-08-14 This book offers a complete discussion of product development in the pharmaceutical and biotechnology industries from discovery, to product launch, through life cycle management. The book is organized for optimal usefulness in the education and training of health care professionals (MD, PharmD, PhD), at universities. The format is a set of figures, tables and lists, along with detailed narrative descriptions, including real-life examples, illustrations, controversies in industry, and references. The editors and authors of the book are industry and research experts in a variety of disciplines. |
| decentralized clinical trials technology: A Concise Guide to Clinical Trials Allan Hackshaw, 2011-09-07 Clinical trials have revolutionized the way disease is prevented, detected and treated, and early death avoided, and they continue to be an expanding area of research. They are central to the work of pharmaceutical companies, and there are many academic and public sector organizations that conduct trials on a wide variety of interventions, including drugs, devices, surgical techniques, and changes in behaviour and lifestyle. A Concise Guide to Clinical Trials provides a comprehensive yet easy-to-read overview of the design, conduct and analysis of trials. It requires no prior knowledge on the subject as the important concepts are introduced throughout. There are chapters that distinguish between the different types of trials, and an introduction to systematic reviews, health-related quality of life and health economic evaluation. The book also covers the ethical and legal requirements in setting up a clinical trial due to an increase in governance responsibilities and regulations. This practical guidebook is ideal for busy clinicians and other health professionals who do not have enough time to attend courses or search through extensive textbooks. It will help anyone involved in undertaking clinical research, or those reading about trials. The book is aimed at: Those wishing to learn about clinical trials for the first time, or as a quick reference guide, for example as part of a taught course on clinical trials Health professionals who wish to conduct their own trials, or participate in other people’s studies People who work in pharmaceutical companies, grant funding organisations, or regulatory agencies |
| decentralized clinical trials technology: Applying Big Data to Address the Social Determinants of Health in Oncology National Academies of Sciences, Engineering, and Medicine, Division on Engineering and Physical Sciences, Committee on Applied and Theoretical Statistics, Health and Medicine Division, Board on Health Care Services, National Cancer Policy Forum, 2020-08-14 The National Academies of Sciences, Engineering, and Medicine held the workshop Applying Big Data to Address the Social Determinants of Health in Oncology on October 28â€29, 2019, in Washington, DC. This workshop examined social determinants of health (SDOH) in the context of cancer, and considered opportunities to effectively leverage big data to improve health equity and reduce disparities. The workshop featured presentations and discussion by experts in technology, oncology, and SDOH, as well as representatives from government, industry, academia, and health care systems. This publication summarizes the presentations and discussions from the workshop. |
| decentralized clinical trials technology: Impure Science Steven Epstein, 1996 Epstein shows the extent to which AIDS research has been a social and political phenomenon and how the AIDS movement has transformed biomedical research practices through its capacity to garner credibility by novel strategies. |
| decentralized clinical trials technology: Rare Disease Drug Development Raymond A. Huml, 2021-11-08 This book provides a broad overview of rare disease drug development. It offers unique insights from various perspectives, including third-party capital providers, caregivers, patient advocacy groups, drug development professionals, marketing and commercial experts, and patients. A unique reference, the book begins with narratives on the many challenges faced by rare disease patient and their caregivers. Subsequent chapters underscore the critical, multidimensional role of patient advocacy groups and the novel approaches to related clinical trials, investment decisions, and the optimization of rare disease registries. The book addresses various rare disease drug development processes by disciplines such as oncology, hematology, pediatrics, and gene therapy. Chapters then address the operational aspects of drug development, including approval processes, development accelerations, and market access strategies. The book concludes with reflections on the authors' case for real-world data and evidence generation in orphan medicinal drug development. Rare Disease Drug Development is an expertly written text optimized for biopharmaceutical R&D experts, commercial experts, third-party capital providers, patient advocacy groups, patients, and caregivers. |
| decentralized clinical trials technology: Readings in Medical Artificial Intelligence William J. Clancey, Edward Hance Shortliffe, 1984 |
| decentralized clinical trials technology: Medical Image Registration Joseph V. Hajnal, Derek L.G. Hill, 2001-06-27 Image registration is the process of systematically placing separate images in a common frame of reference so that the information they contain can be optimally integrated or compared. This is becoming the central tool for image analysis, understanding, and visualization in both medical and scientific applications. Medical Image Registration provid |
| decentralized clinical trials technology: The Patient Will See You Now Eric Topol, 2016-10-25 The essential guide by one of America's leading doctors to how digital technology enables all of us to take charge of our health A trip to the doctor is almost a guarantee of misery. You'll make an appointment months in advance. You'll probably wait for several hours until you hear the doctor will see you now-but only for fifteen minutes! Then you'll wait even longer for lab tests, the results of which you'll likely never see, unless they indicate further (and more invasive) tests, most of which will probably prove unnecessary (much like physicals themselves). And your bill will be astronomical. In The Patient Will See You Now, Eric Topol, one of the nation's top physicians, shows why medicine does not have to be that way. Instead, you could use your smartphone to get rapid test results from one drop of blood, monitor your vital signs both day and night, and use an artificially intelligent algorithm to receive a diagnosis without having to see a doctor, all at a small fraction of the cost imposed by our modern healthcare system. The change is powered by what Topol calls medicine's Gutenberg moment. Much as the printing press took learning out of the hands of a priestly class, the mobile internet is doing the same for medicine, giving us unprecedented control over our healthcare. With smartphones in hand, we are no longer beholden to an impersonal and paternalistic system in which doctor knows best. Medicine has been digitized, Topol argues; now it will be democratized. Computers will replace physicians for many diagnostic tasks, citizen science will give rise to citizen medicine, and enormous data sets will give us new means to attack conditions that have long been incurable. Massive, open, online medicine, where diagnostics are done by Facebook-like comparisons of medical profiles, will enable real-time, real-world research on massive populations. There's no doubt the path forward will be complicated: the medical establishment will resist these changes, and digitized medicine inevitably raises serious issues surrounding privacy. Nevertheless, the result-better, cheaper, and more human health care-will be worth it. Provocative and engrossing, The Patient Will See You Now is essential reading for anyone who thinks they deserve better health care. That is, for all of us. |
| decentralized clinical trials technology: Community Health Equity Fernando De Maio, Raj C. Shah, MD, John Mazzeo, David A. Ansell, MD, 2019-03-29 Perhaps more than any other American city, Chicago has been a center for the study of both urban history and economic inequity. Community Health Equity assembles a century of research to show the range of effects that Chicago’s structural socioeconomic inequalities have had on patients and medical facilities alike. The work collected here makes clear that when a city is sharply divided by power, wealth, and race, the citizens who most need high-quality health care and social services have the greatest difficulty accessing them. Achieving good health is not simply a matter of making the right choices as an individual, the research demonstrates: it’s the product of large-scale political and economic forces. Understanding these forces, and what we can do to correct them, should be critical not only to doctors but to sociologists and students of the urban environment—and no city offers more inspiring examples for action to overcome social injustice in health than Chicago. |
| decentralized clinical trials technology: Applications of Blockchain in Healthcare Suyel Namasudra, Ganesh Chandra Deka, 2021-02-12 This book discusses applications of blockchain in healthcare sector. The security of confidential and sensitive data is of utmost importance in healthcare industry. The introduction of blockchain methods in an effective manner will bring secure transactions in a peer-to-peer network. The book also covers gaps of the current available books/literature available for use cases of Distributed Ledger Technology (DLT) in healthcare. The information and applications discussed in the book are immensely helpful for researchers, database professionals, and practitioners. The book also discusses protocols, standards, and government regulations which are very useful for policymakers. /div /div /div /div /div /div /div /div /div /div /div /div /div /div /div /div /div |
| decentralized clinical trials technology: CRISPR-Cas Systems Rodolphe Barrangou, John van der Oost, 2012-12-13 CRISPR/Cas is a recently described defense system that protects bacteria and archaea against invasion by mobile genetic elements such as viruses and plasmids. A wide spectrum of distinct CRISPR/Cas systems has been identified in at least half of the available prokaryotic genomes. On-going structural and functional analyses have resulted in a far greater insight into the functions and possible applications of these systems, although many secrets remain to be discovered. In this book, experts summarize the state of the art in this exciting field. |
| decentralized clinical trials technology: Clinical Trial Simulations Holly H. C. Kimko, Carl C. Peck, 2010-12-09 This edition includes both updates and new uses and issues concerning CTS, along with case studies of how clinical trial simulations are being applied in various therapeutic and application areas. Importantly, the book expands on the utility of CTS for informing decisions during drug development and regulatory review. Each chapter author was selected on the basis of demonstrated expertise in state-of-the-art application of CTS. The target audience for this volume includes researchers and scientists who wish to consider use of simulations in the design, analysis, or regulatory review and guidance of clinical trials. This book does not embrace all aspects of trial design, nor is it intended as a complete recipe for using computers to design trials. Rather, it is an information source that enables the reader to gain understanding of essential background and knowledge for practical applications of simulation for clinical trial design and analysis. It is assumed that the reader has a working understanding of pharmacokinetics and pharmacodynamics, modeling, pharmacometric analyses, and/or the drug development and regulatory processes. |
| decentralized clinical trials technology: Clinical Research Informatics Rachel Richesson, James Andrews, 2012-02-15 The purpose of the book is to provide an overview of clinical research (types), activities, and areas where informatics and IT could fit into various activities and business practices. This book will introduce and apply informatics concepts only as they have particular relevance to clinical research settings. |
| decentralized clinical trials technology: Transforming Clinical Research in the United States Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2010-10-22 An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise. |
CTTI Recommendations: Decentralized Clinical Trials
To facilitate the adoption and appropriate use of mobile technology in clinical trials, the Clinical Trials Transformation Initiative (CTTI) initiated the Mobile Clinical Trials (MCT) Program, which …
Decentralizing Clinical Trials - ppd.com
companies of the Association of Clinical Research Organizations (ACRO) (www.acrohealth.org) have paved the way in designing, executing, and refining decentralized clinical trials (DCTs). …
Digital Health Technologies and Decentralized Clinical Trials
Decentralized clinical trials - a package of strategies to bring the trial to the patient •Video and telemedicine visits •Direct distribution of product •Electronic informed consent
Decentralized Clinical Trials: The Future of Clinical Research Is …
Improvements in technologies and methods to drive clinical trial innovations have focused on the incorporation of decentralized clinical trials (DCTs)—also sometimes referred to as “remote,” …
Diversification & Technology In Decentralized Clinical Trials
These community-based DCT models can enable an increase in patient reach, improve recruitment and retention, and help keep trials on time and within budget. One of the fastest …
Decentralized Clinical Trials
We consider a decentralized clinical trial to be a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. Why is FDA interested? …
Decentralized clinical trials: From evolution to revolution - SAS
In this paper, we’ll examine how the COVID-19 pandemic and other events set the stage for disruption in clinical trials. In addition, we’ll explore the current paradigm for decentralized …
Seizing Opportunities: Overcoming the Challenges of …
Decentralized Clinical Trials (DCT) have gained significant attention in recent years as it brings a new paradigm enriching the clinical trial landscape with a suite of options that transcend the …
Decentralizing Clinical Trials - ACRO
companies of the Association of Clinical Research Organizations (ACRO) (www.acrohealth.org) have paved the way in designing, executing, and refining decentralized clinical trials (DCTs). …
DIGITAL HEALTH TRIALS - CTTI
CTTI defines decentralized clinical trials (DCTs) as those in which some or all study assessments or visits are conducted at locations other than the investigator site via any or all of the following …
Decentralized clinical trials - HCLTech
The Medable-HCL decentralized clinical trial solution is modeled on direct to patient interaction technology, leveraging wearables, and home-based physiological devices, geared up to help …
The Modernization of Clinical Trials through Digital Health ...
The Modernization of Clinical Trials through Digital Health Technologies (DHTs), Decentralized Clinical Trials (DCTs), and Point of Care Trials Elizabeth Kunkoski, MS Health Science Policy...
EBOOK Your Blueprint for Decentralized Clinical Trials
In decentralized clinical trials (DCTs), studies are being carried out using electronic patient reported outcomes (ePRO/surveys), eConsent, text messages, drug kits sent by mail, patient …
INSIGHT BRIEF Decentralized Clinical Trial Technology— How …
today’s more agile clinical research design, enabling up to 21x faster enrollment, 28% better retention, and 3x more diverse patient population. To learn more about our solutions, and how …
A New Path Forward for Using Decentralized Clinical Trials
Oct 19, 2018 · Develop evidence-based recommendations that affect the widespread adoption and use of mobile technology in clinical trials for regulatory submission. Increased number of …
Evolution of Decentralized Clinical Trials | Sterling IRB
Decentralized clinical trials (DCTs) are transforming the research landscape, reflecting a significant shift in the industry’s approach to study design and participant engagement.
Digital Health Technologies & Decentralized Clinical Trials
All Digital Health Technologies for use in clinical trials need to be cleared/approved by FDA. True/False? Justification of an endpoint as clinically meaningful depends on the DHT used.
Advancing Adoption of Decentralized Clinical Trials: Rationale, …
Leveraging technology, electronic clinical data, and remote monitoring tools have enabled advancements in clinical trials to drive improvements in clinical and biomedical research.
Digital Health Technologies & Decentralized Clinical Trials
• Many decentralized trials will end up as hybrid-scombinations of remote visits and visits to investigator sites when procedures such as detailed physical exams and other in-person …
Decentralized clinical trials - ppd.com
A patient-centered approach to neurology trials has evolved with remote decentralized monitoring being made possible by DTP and DFP shipments, mobile technology, digital wearable …
CTTI Recommendations: Decentralized Clinical Trials
To facilitate the adoption and appropriate use of mobile technology in clinical trials, the Clinical Trials Transformation Initiative (CTTI) initiated the Mobile Clinical Trials (MCT) Program, which …
Decentralizing Clinical Trials - ppd.com
companies of the Association of Clinical Research Organizations (ACRO) (www.acrohealth.org) have paved the way in designing, executing, and refining decentralized clinical trials (DCTs). …
Digital Health Technologies and Decentralized Clinical Trials
Decentralized clinical trials - a package of strategies to bring the trial to the patient •Video and telemedicine visits •Direct distribution of product •Electronic informed consent
Decentralized Clinical Trials: The Future of Clinical Research …
Improvements in technologies and methods to drive clinical trial innovations have focused on the incorporation of decentralized clinical trials (DCTs)—also sometimes referred to as “remote,” …
Diversification & Technology In Decentralized Clinical Trials
These community-based DCT models can enable an increase in patient reach, improve recruitment and retention, and help keep trials on time and within budget. One of the fastest …
Decentralized Clinical Trials
We consider a decentralized clinical trial to be a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. Why is FDA interested? …
Decentralized clinical trials: From evolution to revolution - SAS
In this paper, we’ll examine how the COVID-19 pandemic and other events set the stage for disruption in clinical trials. In addition, we’ll explore the current paradigm for decentralized …
Seizing Opportunities: Overcoming the Challenges of …
Decentralized Clinical Trials (DCT) have gained significant attention in recent years as it brings a new paradigm enriching the clinical trial landscape with a suite of options that transcend the …
Decentralizing Clinical Trials - ACRO
companies of the Association of Clinical Research Organizations (ACRO) (www.acrohealth.org) have paved the way in designing, executing, and refining decentralized clinical trials (DCTs). …
DIGITAL HEALTH TRIALS - CTTI
CTTI defines decentralized clinical trials (DCTs) as those in which some or all study assessments or visits are conducted at locations other than the investigator site via any or all of the following …
Decentralized clinical trials - HCLTech
The Medable-HCL decentralized clinical trial solution is modeled on direct to patient interaction technology, leveraging wearables, and home-based physiological devices, geared up to help …
The Modernization of Clinical Trials through Digital Health ...
The Modernization of Clinical Trials through Digital Health Technologies (DHTs), Decentralized Clinical Trials (DCTs), and Point of Care Trials Elizabeth Kunkoski, MS Health Science Policy...
EBOOK Your Blueprint for Decentralized Clinical Trials
In decentralized clinical trials (DCTs), studies are being carried out using electronic patient reported outcomes (ePRO/surveys), eConsent, text messages, drug kits sent by mail, patient …
INSIGHT BRIEF Decentralized Clinical Trial Technology— …
today’s more agile clinical research design, enabling up to 21x faster enrollment, 28% better retention, and 3x more diverse patient population. To learn more about our solutions, and how …
A New Path Forward for Using Decentralized Clinical Trials
Oct 19, 2018 · Develop evidence-based recommendations that affect the widespread adoption and use of mobile technology in clinical trials for regulatory submission. Increased number of …
Evolution of Decentralized Clinical Trials | Sterling IRB
Decentralized clinical trials (DCTs) are transforming the research landscape, reflecting a significant shift in the industry’s approach to study design and participant engagement.
Digital Health Technologies & Decentralized Clinical Trials
All Digital Health Technologies for use in clinical trials need to be cleared/approved by FDA. True/False? Justification of an endpoint as clinically meaningful depends on the DHT used.
Advancing Adoption of Decentralized Clinical Trials: …
Leveraging technology, electronic clinical data, and remote monitoring tools have enabled advancements in clinical trials to drive improvements in clinical and biomedical research.
Digital Health Technologies & Decentralized Clinical Trials
• Many decentralized trials will end up as hybrid-scombinations of remote visits and visits to investigator sites when procedures such as detailed physical exams and other in-person …
Decentralized clinical trials - ppd.com
A patient-centered approach to neurology trials has evolved with remote decentralized monitoring being made possible by DTP and DFP shipments, mobile technology, digital wearable …
