Digital Therapeutics: Strategic, Scientific, Developmental, and Regulatory Aspects
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Description
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. Cover Half Title Series Page Title Page Copyright Page Contents Preface List of Abbreviations Editors Contributors 1. Digital Therapeutics within the Digital Health Landscape: Foundational Aspects 2. Sector Perspective: Digital Therapeutics in Behavioral Health 3. Navigating the Code to Commercial Lifecycle of Digital Health Apps: Defining and Defending Your Strategy for Success 4. Designing and Delivering a DTx Clinical Research Program: No Need to Re-invent the Wheel 5. Statistical Designs for Developing Personalized Mobile Treatment Interventions 6. Statistical Approaches in the Development of Digital Therapeutics 7. Health Economics Aspects of Digital Therapeutics 8. Healthcare Data Ownership and Privacy: A Perspective for Digital Therapeutics 9. Building the Story of Scientific Evidence for Digital Therapeutics: Trials, Meta-Analysis, and Real-World Data 10. US Regulatory Pathways for Digital Therapeutics 11. Building Digital Health and Therapeutic Solutions for the Future: What's Required for Success? 12. Digital Therapeutics for Sleep and Mental Health 13. DTx for the NEXT three billion! 14. Akili: A Novel Approach to Clinical Intervention with Digital Therapeutics 15. SilverCloud Health: Online Mental Health and Wellbeing Platform 16. Digitally Augmenting Therapies: A DTx Opportunity for Pharma Portfolio Development 17. The Convergence of Digital Health Technologies: The Role of Digital Therapeutics in the Future Healthcare System 18. Decentralized Clinical Trials: A New Paradigm for New Medical Product Development and Digital Therapeutics 19. The Past, Present, and Future of Digital Therapeutics Index
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