The Role of Digital Health Technologies in Drug Development

National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Roundtable on Genomics and Precision Health; Forum on Drug Discovery, Development, and Translation; Carolyn Shore; Sarah H. Beachy; Anna Nicholson; Siobhan Addie; Meredith Hackmann; Eeshan Khandekar

doi:10.17226/25850

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The Role of Digital Health Technologies in Drug Development

Proceedings of a Workshop

National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Roundtable on Genomics and Precision Health; Forum on Drug Discovery, Development, and Translation; Editors: Carolyn Shore, Rapporteur, Sarah H. Beachy, Rapporteur, Anna Nicholson, Rapporteur, Siobhan Addie, Rapporteur, Meredith Hackmann, Rapporteur, and Eeshan Khandekar, Rapporteur.

Washington (DC): National Academies Press (US); 2020 Aug 28.

ISBN-13: 978-0-309-67959-6ISBN-10: 0-309-67959-1

Hardcopy Version at National Academies Press

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.

The National Academies of SCIENCES • ENGINEERING • MEDICINE
PLANNING COMMITTEE FOR A WORKSHOP ON THE ROLE OF DIGITAL HEALTH TECHNOLOGIES IN DRUG DEVELOPMENT
FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION
ROUNDTABLE ON GENOMICS AND PRECISION HEALTH
Reviewers
Acknowledgments
Acronyms and Abbreviations
1. Introduction
2. Ethical and Regulatory Considerations for Digital Health Technologies
3. Digital Health Technologies for Characterizing Disease
- CHALLENGES IN DERIVING HEALTH INSIGHTS FROM REAL-WORLD SENSOR DATA
  Larsson Omberg, Vice President of Systems Biology.
- DIGITAL DATA COLLECTION BY THE ALL OF US RESEARCH PROGRAM
  Chris Lunt, Chief Technology Officer.
- ADOPTION OF DIGITAL HEALTH TECHNOLOGIES
  Alicia Staley, Senior Director of Patient Engagement.
- DISCOVERY THROUGH PERSON-GENERATED HEALTH DATA
  Luca Foschini, Chief Data Scientist and Co-Founder.
- DISCUSSION
4. Digital Health Technologies for Recruitment and Safety
- REGULATORY PERSPECTIVE ON DRUG DEVELOPMENT TOOLS
  Christopher Leptak, Director.
- ENGAGING THE PUBLIC IN RESEARCH USING MOBILE HEALTH
  Yvonne Yu-Feng Chan, Senior Director.
- DIGITAL HEALTH TECHNOLOGIES AND REMOTE MONITORING IN DRUG DEVELOPMENT
  Chris Benko, Chief Executive Officer.
- DIGITAL HEALTH TECHNOLOGIES AND THE COVID-19 PANDEMIC
- DEPLOYING DIGITAL HEALTH TECHNOLOGIES AT THE INTERSECTION OF CLINICAL CARE AND RESEARCH
  Eric Perakslis, Rubenstein Fellow.
- DISCUSSION
5. Digital Health Technologies for Pivotal Trials
- INDUSTRY PERSPECTIVE ON DIGITAL HEALTH TECHNOLOGIES IN PIVOTAL TRIALS
  Sean Khozin, Global Head of Data Strategy.
- PERFORMANCE REQUIREMENTS FOR DIGITAL HEALTH TECHNOLOGIES IN PIVOTAL TRIALS
  Ritu Kapur, Head of Biomarkers.
- REGULATORY PERSPECTIVE ON THE USE OF DIGITAL HEALTH TECHNOLOGIES IN PIVOTAL TRIALS
  Leonard Sacks, Associate Director for Clinical Methodology.
- DISCUSSION
6. Digital Health Technologies for Enhancing Real-World Evidence Collection, Patient Centricity, and Post-Market Studies
- DIGITAL HEALTH TECHNOLOGIES FOR POST-MARKETING RESEARCH AND SURVEILLANCE
  Michelle Crouthamel, Director of Digital Health and Innovation.
- USE OF DIGITAL HEALTH TECHNOLOGIES TO EMPOWER PATIENT PARTICIPATION
  Sally Okun, Director of Policy and Ethics.
- CLINICIAN PERSPECTIVE ON DIGITAL HEALTH TECHNOLOGIES FOR POST-MARKETING RESEARCH AND SURVEILLANCE
  Edmondo Robinson, Chief Digital Innovation Officer.
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

This activity was supported by contracts between the National Academy of Sciences and 23andMe; AbbVie Inc.; American Academy of Nursing; American College of Medical Genetics and Genomics; American Medical Association; Amgen Inc. (Contract No. GHCCOPS-CSARF-175837); Association for Molecular Pathology; Association of American Medical Colleges; AstraZeneca; Biogen; Blue Cross Blue Shield Association; Burroughs Wellcome Fund (Contract No. 1020264); College of American Pathologists; Color Genomics; Critical Path Institute; Department of Health and Human Services (Contract No. 75A50120C00006): Health Resources and Services Administration (Contract No. HHSH250201500001I; Task Order No. HHSH25034003T); Eisai Inc.; Eli Lilly and Company (Contract No. 4900709231); FasterCures–Milken Institute; Foundation for the National Institutes of Health; Friends of Cancer Research; Geisinger; Genome Medical Holding Company; Genosity; GlaxoSmithKline (Contract No. OTH-PPL-32245); Helix; Illumina; The Jackson Laboratory; Janssen Research & Development, LLC (Contract No. C2020004715); Johnson & Johnson; Kaiser Permanente; Merck & Co., Inc. (MRLCPO-19-5290 and MRLCPO-10-106723); Myriad Women's Health; National Institutes of Health (Contract No. HHSN263201800029I; Task Order Nos. HHSN26300007 and HHSN26300010): All of Us Research Program, National Cancer Institute, National Center for Advancing Translational Sciences, National Human Genome Research Institute, National Institute of Allergy and Infectious Diseases, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, National Institute of Nursing Research, National Institute on Aging, Office of Disease Prevention, Office of Extramural Research, Office of Science Policy; National Society of Genetic Counselors; New England Journal of Medicine; Pfizer Inc.; Regeneron Pharmaceuticals; Sanofi (Contract No. 4472309 and Contract No. 57505685); Takeda Pharmaceuticals (Contract No. 53108); The University of Vermont Health Network Medical Group; U.S. Air Force Medical Service (Contract No. FA8052-17-P-0007); U.S. Food and Drug Administration (Grant No. 5R13FD005496-04 and Grant No. 5R13FD005496-05); and Vibrent Health. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

Suggested citation:

National Academies of Sciences, Engineering, and Medicine. 2020. The role of digital health technologies in drug development: Proceedings of a workshop. Washington, DC: The National Academies Press. http://doi.org/10.17226/25850.

Digital Object Identifier: https://doi.org/10.17226/25850

Additional copies of this publication are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu.

Printed in the United States of America

Bookshelf ID: NBK561335PMID: 32870622DOI: 10.17226/25850

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National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Roundtable on Genomics and Precision Health; Forum on Drug Discovery, Development, and Translation; Shore C, Beachy SH, Nicholson A, et al., editors. The Role of Digital Health Technologies in Drug Development: Proceedings of a Workshop. Washington (DC): National Academies Press (US); 2020 Aug 28. doi: 10.17226/25850
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