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The Role of Digital Health Technologies in Drug Development

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2020-11-28

Total Pages: 143

ISBN-13: 0309679591

On March 24, 2020, a 1-day public workshop titled The Role of Digital Health Technologies in Drug Development was convened by the National Academies of Sciences, Engineering, and Medicine. This workshop builds on prior efforts to explore how virtual clinical trials facilitated by digital health technologies (DHTs) might change the landscape of drug development. To explore the challenges and opportunities in using DHTs for improving the probability of success in drug R&D, enabling better patient care, and improving precision medicine, the workshop featured presentations and panel discussions on the integration of DHTs across all phases of drug development. Throughout the workshop, participants considered how DHTs could be applied to achieve the greatest impactâ€"and perhaps even change the face of how clinical trials are conductedâ€"in ways that are also ethical, equitable, safe, and effective. This publication summarizes the presentations and discussions from the workshop.

Neuroscience Trials of the Future

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2016-11-07

Total Pages: 111

ISBN-13: 0309442583

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On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future.

Virtual Clinical Trials

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2019-11-16

Total Pages: 127

ISBN-13: 0309494885

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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.

Digital Health Entrepreneurship

Author: Sharon Wulfovich

Publisher: Springer

Published: 2019-06-20

Total Pages: 226

ISBN-13: 3030127192

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This book presents a hands on approach to the digital health innovation and entrepreneurship roadmap for digital health entrepreneurs and medical professionals who are dissatisfied with the existing literature on or are contemplating getting involved in digital health entrepreneurship. Topics covered include regulatory affairs featuring detailed guidance on the legal environment, protecting digital health intellectual property in software, hardware and business processes, financing a digital health start up, cybersecurity best practice, and digital health business model testing for desirability, feasibility, and viability. Digital Health Entrepreneurship is directed to clinicians and other digital health entrepreneurs and stresses an interdisciplinary approach to product development, deployment, dissemination and implementation. It therefore provides an ideal resource for medical professionals across a broad range of disciplines seeking a greater understanding of digital health innovation and entrepreneurship.

The Role of NIH in Drug Development Innovation and Its Impact on Patient Access

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2020-02-27

Total Pages: 103

ISBN-13: 0309498481

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To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.

An Examination of Emerging Bioethical Issues in Biomedical Research

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2020-09-10

Total Pages: 133

ISBN-13: 0309676630

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On February 26, 2020, the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine hosted a 1-day public workshop in Washington, DC, to examine current and emerging bioethical issues that might arise in the context of biomedical research and to consider research topics in bioethics that could benefit from further attention. The scope of bioethical issues in research is broad, but this workshop focused on issues related to the development and use of digital technologies, artificial intelligence, and machine learning in research and clinical practice; issues emerging as nontraditional approaches to health research become more widespread; the role of bioethics in addressing racial and structural inequalities in health; and enhancing the capacity and diversity of the bioethics workforce. This publication summarizes the presentations and discussions from the workshop.

The Role of Digital Health Technologies in Drug Development

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2020-10-28

Total Pages: 143

ISBN-13: 0309679621

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New Health Technologies

Author: OECD

Publisher: Org. for Economic Cooperation & Development

Published: 2017

Total Pages: 0

ISBN-13: 9789264266421

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Chapter 1. New health technologies: Managing access, value and sustainability Chapter 2. The past and potential future impact of new health technology Chapter 3. Innovation, access and value in pharmaceuticals Chapter 4. Ensuring timely and affordable access to medical devices Chapter 5. Achieving the promise of precision medicine Chapter 6. Digital technology: Making better use of health data

Social Aspects of Drug Discovery, Development and Commercialization

Author: Odilia Osakwe

Publisher: Academic Press

Published: 2016-02-18

Total Pages: 324

ISBN-13: 0128024976

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Social Aspects of Drug Discovery, Development and Commercialization provides an insightful analysis of the drug discovery and development landscape as it relates to society. This book examines the scientific, legal, philosophical, economic, political, ethical and cultural factors that contribute to drug development. The pharmaceutical industry is under scrutiny to develop safer and more effective drugs in a quicker and more affordable manner. Recent criticism and debates have emphasized varying opinions on the issues concerning the drug discovery and development process. This book provides thoughtful and valuable discussions and analysis of the social challenges and potential opportunities through all stages of the pharmaceutical process, from inception through marketing. With a unique focus on the social factors that increasingly play a role in how drug development is planned, structured, and executed throughout the drug product lifecycle, this is an essential resource for students, professors, and researchers who seek a better understanding of the interface between the pharmaceutical industry, health care systems, and society. Organized in a sequence of interrelated theories and principles that provide the foundation for increased understanding of the relevant social aspects Includes analysis of important new advances, key scientific and strategic issues, and overviews of recent progress in drug development Provides a global perspective with examples from developed areas, such as the US, Japan, Canada and Europe, as well as faster-growing and emerging economies including Brazil, Russia, India, and China Serves as an essential resource for students, professors, and researchers who seek a better understanding of the interface between the pharmaceutical industry, health care systems, and society

Global Health and the Future Role of the United States

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2017-09-05

Total Pages: 385

ISBN-13: 0309457661

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While much progress has been made on achieving the Millenium Development Goals over the last decade, the number and complexity of global health challenges has persisted. Growing forces for globalization have increased the interconnectedness of the world and our interdependency on other countries, economies, and cultures. Monumental growth in international travel and trade have brought improved access to goods and services for many, but also carry ongoing and ever-present threats of zoonotic spillover and infectious disease outbreaks that threaten all. Global Health and the Future Role of the United States identifies global health priorities in light of current and emerging world threats. This report assesses the current global health landscape and how challenges, actions, and players have evolved over the last decade across a wide range of issues, and provides recommendations on how to increase responsiveness, coordination, and efficiency â€" both within the U.S. government and across the global health field.