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Suggested Citation:"Front Matter." 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. doi: 10.17226/25850.
×

THE ROLE OF DIGITAL
HEALTH TECHNOLOGIES
IN DRUG DEVELOPMENT

PROCEEDINGS OF A WORKSHOP

Eeshan Khandekar, Meredith Hackmann, Siobhan Addie,
Anna Nicholson, Sarah H. Beachy, and Carolyn Shore, Rapporteurs

Forum on Drug Discovery, Development, and Translation

Roundtable on Genomics and Precision Health

Board on Health Sciences Policy

Health and Medicine Division

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THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu

Suggested Citation:"Front Matter." 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. doi: 10.17226/25850.
×

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

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.

International Standard Book Number-13: 978-0-309-67959-6
International Standard Book Number-10: 0-309-67959-1
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.

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Printed in the United States of America

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.

Suggested Citation:"Front Matter." 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. doi: 10.17226/25850.
×

Image

The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president.

The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. John L. Anderson is president.

The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president.

The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine.

Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org.

Suggested Citation:"Front Matter." 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. doi: 10.17226/25850.
×

Image

Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task.

Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies.

For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo.

Suggested Citation:"Front Matter." 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. doi: 10.17226/25850.
×

PLANNING COMMITTEE FOR A WORKSHOP ON THE ROLE OF DIGITAL HEALTH TECHNOLOGIES IN DRUG DEVELOPMENT1

JENNIFER GOLDSACK (Co-Chair), Executive Director, Digital Medicine Society

JOSEPH P. MENETSKI (Co-Chair), Associate Vice President of Research Partnerships, Foundation for the National Institutes of Health

LINDA BRADY, Director, Division of Neuroscience and Basic Behavioral Science, National Institute of Mental Health

RAY DORSEY, Professor, University of Rochester Medical Center

DEBORAH ESTRIN, Associate Dean, Cornell Tech

GEOFFREY GINSBURG, Director, Center for Applied Genomics & Precision Medicine, Duke University School of Medicine

HUSSEINI K. MANJI, Global Therapeutic Head, Neuroscience, Janssen Research & Development, LLC

DEVEN MCGRAW, Chief Regulatory Officer, Ciitizen Corporation

LAUREN OLIVA, Global Regulatory Policy Lead, Biogen

BRAY PATRICK-LAKE, Director of Strategic Partnerships, Evidation Health

LEONARD SACKS, Associate Director of Clinical Methodology, Office of Medical Policy, Center for Drug Evaluation and Research; U.S. Food and Drug Administration

JOYCE TUNG, Vice President, Research, 23andMe

EFFY VAYENA, Professor, Health Ethics and Policy Lab; ETH Zurich

Board on Health Sciences Policy Staff

SARAH H. BEACHY, Senior Program Officer

CAROLYN SHORE, Senior Program Officer

SIOBHAN ADDIE, Program Officer

MEREDITH HACKMANN, Associate Program Officer

EESHAN KHANDEKAR, Associate Program Officer

MICHAEL BERRIOS, Research Associate (until March 2020)

KELLY CHOI, Senior Program Assistant (from March 2020)

MELVIN JOPPY, Senior Program Assistant

ANDREW M. POPE, Senior Board Director

___________________

1 The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." 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. doi: 10.17226/25850.
×

FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION1

ROBERT M. CALIFF (Co-Chair), Duke University and Verily Life Sciences

GREGORY SIMON (Co-Chair), Kaiser Permanente Washington Health Research Institute and University of Washington

AMY ABERNETHY, U.S. Food and Drug Administration

CHRISTOPHER P. AUSTIN, National Center for Advancing Translational Sciences

LINDA BRADY, National Institute of Mental Health

RICK BRIGHT, Biomedical Advanced Research and Development Authority

BARRY COLLER, The Rockefeller University

THOMAS CURRAN, Children’s Mercy, Kansas City

RICHARD DAVEY, National Institute of Allergy and Infectious Diseases

KATHERINE DAWSON, Biogen

JAMES H. DOROSHOW, National Cancer Institute

JEFFREY M. DRAZEN,New England Journal of Medicine

STEVEN K. GALSON, Amgen Inc.

CARLOS GARNER, Eli Lilly and Company

JULIE L. GERBERDING, Merck & Co., Inc.

ANNE HEATHERINGTON, Takeda Pharmaceuticals

DEBORAH HUNG, Harvard Medical School

ESTHER KROFAH, FasterCures–Milken Institute

LISA LaVANGE, University of North Carolina Gillings School of Global Public Health

ROSS McKINNEY, JR., Association of American Medical Colleges

JOSEPH P. MENETSKI, Foundation for the National Institutes of Health

ARTI RAI, Duke University School of Law

KELLY ROSE, Burroughs Wellcome Fund

SUSAN SCHAEFFER, The Patients’ Academy for Research Advocacy

JOSEPH SCHEEREN, Critical Path Institute

ROB SCOTT, AbbVie Inc.

ANANTHA SHEKHAR, Indiana University School of Medicine

JAY SIEGEL (retired)

___________________

1 The National Academies of Sciences, Engineering, and Medicine’s forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." 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. doi: 10.17226/25850.
×

ELLEN V. SIGAL, Friends of Cancer Research

LANA R. SKIRBOLL, Sanofi

AMIR TAMIZ, National Institute of Neurological Disorders and Stroke

ANN TAYLOR, AstraZeneca

PAMELA TENAERTS, Clinical Trials Transformation Initiative, Duke University

JOANNE WALDSTREICHER, Johnson & Johnson

JONATHAN WATANABE, University of California, San Diego

CARRIE WOLINETZ, Office of Science Policy, National Institutes of Health

ALASTAIR WOOD, Vanderbilt University

JANET WOODCOCK, U.S. Food and Drug Administration

Forum Staff

CAROLYN SHORE, Forum Director

AMANDA WAGNER GEE, Program Officer

JENNIFER HINNERS, Program Officer

EESHAN KHANDEKAR, Associate Program Officer

MELVIN JOPPY, Senior Program Assistant

Page viii Cite
Suggested Citation:"Front Matter." 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. doi: 10.17226/25850.
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ROUNDTABLE ON GENOMICS AND PRECISION HEALTH1

GEOFFREY GINSBURG (Co-Chair), Duke University

MICHELLE PENNY (Co-Chair), Goldfinch Bio

NAOMI ARONSON, Blue Cross Blue Shield Association

ARIS BARAS, Regeneron Pharmaceuticals

KARINA BIENFAIT, Merck and Co., Inc.

VENCE BONHAM, JR., National Human Genome Research Institute

ROBERT B. DARNELL, The Rockefeller University and New York Genome Center

STEPHANIE DEVANEY, All of Us Research Program, National Institutes of Health

KATHERINE DONIGAN, U.S. Food and Drug Administration

W. GREGORY FEERO,Journal of the American Medical Association

JESSICA M. GILL, National Institute of Nursing Research

JENNIFER GOLDSACK, Digital Medicine Society

MARC GRODMAN, Genosity

RICHARD J. HODES, National Institute on Aging

PRADUMAN JAIN, Vibrent Health

SALLY JOHN, Biogen

SEKAR KATHIRESAN, Massachusetts General Hospital

MUIN KHOURY, Centers for Disease Control and Prevention

DAVID LEDBETTER, Geisinger

CHARLES LEE, The Jackson Laboratory for Genomic Medicine

THOMAS LEHNER, National Institute of Mental Health

DEBRA LEONARD, College of American Pathologists

PATRICK LOERCH, Johnson & Johnson

JAMES LU, Helix

SEAN MCCONNELL, American Medical Association

MONA MILLER, American Society of Human Genetics

JENNIFER MOSER, Department of Veterans Affairs

MAXIMILIAN MUENKE, American College of Medical Genetics and Genomics

ANNA PETTERSSON, Pfizer Inc.

VICTORIA M. PRATT, Association for Molecular Pathology

NADEEM SARWAR, Eisai Inc.

SHERI SCHULLY, Office of Disease Prevention, National Institutes of Health

JOAN A. SCOTT, Health Resources and Services Administration

___________________

1 The National Academies of Sciences, Engineering, and Medicine’s forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." 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. doi: 10.17226/25850.
×

SAM SHEKAR, American College of Preventive Medicine

NONNIEKAYE SHELBURNE, National Cancer Institute

NIKOLETTA SIDIROPOULOS, The University of Vermont Health Network Medical Group

KATHERINE JOHANSEN TABER, Myriad Women’s Health

RYAN TAFT, Illumina

JACQUELYN TAYLOR, Columbia University

SHARON TERRY, Genetic Alliance

JOYCE TUNG, 23andMe

JAMESON VOSS, Air Force Medical Support Agency

CATHERINE A. WICKLUND, National Society of Genetic Counselors

HUNTINGTON F. WILLARD, Genome Medical

JANET K. WILLIAMS, American Academy of Nursing

SARAH WORDSWORTH, University of Oxford

ALICIA ZHOU, Color Genomics

Roundtable Staff

SARAH H. BEACHY, Roundtable Director

SIOBHAN ADDIE, Program Officer

MEREDITH HACKMANN, Associate Program Officer

MICHAEL BERRIOS, Research Associate (until March 2020)

KELLY CHOI, Senior Program Assistant (from March 2020)

Suggested Citation:"Front Matter." 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. doi: 10.17226/25850.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/25850.
×

Reviewers

This Proceedings of a Workshop was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process.

We thank the following individuals for their review of this proceedings:

ANDREA CORAVOS, Elektra Labs

SUSAN SCHAEFFER, The Patients’ Academy for Research Advocacy

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the proceedings nor did they see the final draft before its release. The review of this proceedings was overseen by ERIC B. LARSON, Kaiser Permanente Washington. He was responsible for making certain that an independent examination of this proceedings was carried out in accordance with standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies.

Suggested Citation:"Front Matter." 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. doi: 10.17226/25850.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/25850.
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Acknowledgments

The support of the Forum on Drug Discovery, Development, and Translation was crucial to the planning and conduct of this workshop on The Role of Digital Health Technologies in Drug Development. Federal sponsors are Department of Health and Human Services; National Institutes of Health (National Cancer Institute, National Center for Advancing Translational Sciences, National Institute of Allergy and Infectious Diseases, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, Office of Extramural Research, Office of Science Policy); and U.S. Food and Drug Administration. Nonfederal sponsorship was provided by AbbVie Inc.; Amgen Inc.; Association of American Medical Colleges; AstraZeneca; Burroughs Wellcome Fund; Critical Path Institute; Eli Lilly and Company; FasterCures–Milken Institute; Foundation for the National Institutes of Health; Friends of Cancer Research; GlaxoSmithKline; Johnson & Johnson; Merck & Co., Inc.; New England Journal of Medicine; Sanofi; and Takeda Pharmaceuticals.

The support of the Roundtable on Genomics and Precision Health was also very important for the workshop. Federal sponsors are Health Resources and Services Administration; National Institutes of Health (All of Us Research Program, National Cancer Institute, National Human Genome Research Institute, National Institute of Mental Health, National Institute of Nursing Research, National Institute on Aging, Office of Disease Prevention); and U.S. Air Force Medical Service. Nonfederal sponsorship was provided by 23andMe; American Academy of Nursing; American College of Medical Genetics and Genomics; American Medi-

Suggested Citation:"Front Matter." 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. doi: 10.17226/25850.
×

cal Association; American Society of Human Genetics; Association for Molecular Pathology; Biogen; Blue Cross Blue Shield Association; College of American Pathologists; Color Genomics; Eisai Inc.; Geisinger; Genome Medical Holding Company; Genosity; Helix; Illumina; The Jackson Laboratory; Janssen Research & Development, LLC; Kaiser Permanente; Merck & Co., Inc.; Myriad Women’s Health; National Society of Genetic Counselors; Pfizer Inc.; Regeneron Pharmaceuticals; The University of Vermont Health Network Medical Group; and Vibrent Health.

The forum and roundtable wish to express gratitude to the members of the planning committee for their work in developing an excellent workshop agenda and to the expert speakers who explored the role of digital health technologies in drug development. The project directors would like to thank the project staff who worked diligently to develop both the workshop and the resulting proceedings.

Suggested Citation:"Front Matter." 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. doi: 10.17226/25850.
×
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Suggested Citation:"Front Matter." 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. doi: 10.17226/25850.
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Acronyms and Abbreviations

3-MST 3-minute step test
12-MRT 12-minute run test
ADAU average daily accelerometry unit
BYOD bring your own device
COA clinical outcome assessment
COVID-19 coronavirus disease 2019
CPU clinical pharmacology unit
DDT drug development tool
DHT digital health technology
EHR electronic health record
FDA U.S. Food and Drug Administration
IND investigational new drug
IRB institutional review board
KCCQ Kansas City Cardiomyopathy Questionnaire
NIH National Institutes of Health
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Suggested Citation:"Front Matter." 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. doi: 10.17226/25850.
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PD Parkinson’s disease
PGHD person-generated health data
PMC post-marketing commitment
PMR post-marketing requirement
R&D research and development
ReCODE Research Center for Optimal Digital Ethics
WHO World Health Organization
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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.

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