The Role of Digital Health Technologies in Drug Development

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 impact—and perhaps even change the face of how clinical trials are conducted—in ways that are also ethical, equitable, safe, and effective. This publication summarizes the presentations and discussions from the workshop.

Table of Contents

• Front Matter
• 1 Introduction
• 2 Ethical and Regulatory Considerations for Digital Health Technologies
• 3 Digital Health Technologies for Characterizing Disease
• 4 Digital Health Technologies for Recruitment and Safety
• 5 Digital Health Technologies for Pivotal Trials
• 6 Digital Health Technologies for Enhancing Real-World Evidence Collection, Patient Centricity, and Post-Market Studies
• 7 Reflections and Key Takeaways
• References
• Appendix A: Workshop Statement of Task
• Appendix B: Workshop Agenda
• Appendix C: Planning Committee Biographical Sketches
• Appendix D: Workshop Speaker Biographical Sketches
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