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The Role of Digital Health Technologies in Drug Development PROCEEDINGS OF A WORKSHOP Eeshan Khandekar, Meredith Hackmann, Siobhan Addie, Anna Nicholson, Sarah 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 PREPUBLICATION COPY—Uncorrected Proofs

THE NATIONAL ACADEMIES PRESS   500 Fifth Street, NW   Washington, DC 20001 This activity was supported by contracts between the National Academy of Sci- ences and 23andMe; AbbVie Inc.; American Academy of Nursing; American Col- lege of Medical Genetics and Genomics; American Medical Association; Amgen Inc. (Contract No. GHCCOPS-CSARF-175837); Association for Molecular Pathol- ogy; Association of American Medical Colleges; AstraZeneca; Biogen; Blue Cross Blue Shield Association; Burroughs Wellcome Fund (Contract No. 1020264); Col- lege of American Pathologists; Color Genomics; Critical Path Institute; Depart- ment 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 Insti- tutes of Health; Friends of Cancer Research; Geisinger; Genome Medical Holding Company; Genosity; GlaxoSmithKline (Contract No. OTH-PPL-32245); Helix; Illu- mina; The Jackson Laboratory; Janssen Research & Development, LLC (Contract No. C2020004715); Johnson & Johnson; Kaiser Permanente; Merck & Co., Inc. (MRLCPO-19-5290 & MRLCPO-10-106723); Myriad Women’s Health; National Institutes of Health (Contract No. HHSN263201800029I; Task Order No. HHSN26300007 and HHSN263201800029I; Task Order No. HHSN26300010): All of Us Research Program, National Cancer Institute, National Center for Advanc- ing 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 Pharma- ceuticals; Sanofi (Contract No. 4472309 and Contract No. 57505685); Takeda Phar- maceuticals (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-XXXXX-X International Standard Book Number-10: 0-309-XXXXX-X Digital Object Identifier: https://doi.org/10.17226/25850 Additional copies of this publication are available for sale from the National A ­ cademies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu. Copyright 2020 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Suggested citation: National Academies of Sciences, Engineering, and Medi- cine. 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. PREPUBLICATION COPY—Uncorrected Proofs

The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institu- tion to advise the nation on issues related to science and ­ echnology. Members t 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 char- ter 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 estab­ished in 1970 under the charter of the National Academy of ­ ciences to l S 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, E ­ ngineering, and Medicine to provide independent, objective analysis and a ­ dvice 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 ­ atters of science, engineering, and medicine. m Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org. PREPUBLICATION COPY—Uncorrected Proofs

Consensus Study Reports published by the National Academies of Sciences, Engi­eering, and Medicine document the evidence-based consensus on the n study’s statement of task by an authoring committee of experts. Reports typi- cally 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 opin- ions 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. PREPUBLICATION COPY—Uncorrected Proofs

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 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 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 speak- ers. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution. v PREPUBLICATION COPY—Uncorrected Proofs

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 ABERTNETHY, 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 round- tables do not issue, review, or approve individual documents. The responsibility for the pub- lished Proceedings of a Workshop rests with the workshop rapporteurs and the institution. vi PREPUBLICATION COPY—Uncorrected Proofs

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 vii PREPUBLICATION COPY—Uncorrected Proofs

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 round- tables do not issue, review, or approve individual documents. The responsibility for the pub- lished Proceedings of a Workshop rests with the workshop rapporteurs and the institution. viii PREPUBLICATION COPY—Uncorrected Proofs

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, Senior Program Officer SIOBHAN ADDIE, Program Officer MEREDITH HACKMANN, Associate Program Officer MICHAEL BERRIOS, Research Associate (until March 2020) KELLY CHOI, Senior Program Assistant (from March 2020) ix PREPUBLICATION COPY—Uncorrected Proofs

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Reviewers This Proceedings of a Workshop was reviewed in draft form by indi- viduals 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, Engineer- ing, 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 com- ments 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 Patient’s 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 accor- dance with standards of the National Academies and that all review com- ments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies. xi PREPUBLICATION COPY—Uncorrected Proofs

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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 Insti- tutes of Health (National Cancer Institute, National Center for Advanc- ing Translational Sciences, National Institute of Allergy and Infectious Diseases, National Institute of Mental Health, National Institute of Neu- rological 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 Insti- tute; 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 Dis- ease Prevention); and U.S. Air Force Medical Service. Nonfederal spon- sorship was provided by 23andMe; American Academy of Nursing; American College of Medical Genetics and Genomics; American Medi- xiii PREPUBLICATION COPY—Uncorrected Proofs

xiv ACKNOWLEDGMENTS 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 Labo- ratory; Janssen Research & Development, LLC; Kaiser Permanente; Merck & Co., Inc.; Myriad Women’s Health; National Society of Genetic Coun- selors; 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 work- shop 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. PREPUBLICATION COPY—Uncorrected Proofs

Contents ACRONYMS AND ABBREVIATIONS XXI 1 INTRODUCTION 1 Use of Digital Health Technology Applications to Address Pain Points Across the Drug Development Lifecycle, 2 Organization of the Workshop, 3 Organization of the Proceedings, 4 2 ETHICAL AND REGULATORY CONSIDERATIONS FOR DIGITAL HEALTH TECHNOLOGIES 5 Categories and Uses of Digital Health Technologies, 6 Using Digital Health Technologies to Capture Real-World Evidence, 10 Ethical, Legal, and Social Implications of Digital Health Technologies and Clinical Research, 11 Considerations for the Future, 17 3 DIGITAL HEALTH TECHNOLOGIES FOR CHARACTERIZING DISEASE 21 Challenges in Deriving Health Insights from Real-World Sensor Data, 23 Digital Data Collection by the All of Us Research Program, 27 Adoption of Digital Health Technologies and Clinical Research, 31 xv PREPUBLICATION COPY—Uncorrected Proofs

xvi CONTENTS Discovery Through Person-Generated Health Data, 34 Discussion, 38 4 DIGITAL HEALTH TECHNOLOGIES FOR RECRUITMENT AND SAFETY  41 Regulatory Perspectives on Drug Development Tools, 43 Engaging the Public in Research Using Mobile Health, 49 Digital Health Technologies and Remote Monitoring in Drug Development, 52 Digital Health Technologies and the COVID-19 Pandemic, 53 Deploying Digital Health Technologies at the Intersection of Clinical Care and Research, 56 Discussion, 60 5 DIGITAL HEALTH TECHNOLOGIES FOR PIVOTAL TRIALS 61 Industry Perspective on Digital Health Technologies in Pivotal Trials, 62 Performance Requirements for Digital Health Technologies in Pivotal Trials, 65 Regulatory Perspective on the Use of Digital Health Technologies in Pivotal Trials, 69 Discussion, 72 6 DIGITAL HEALTH TECHNOLOGIES FOR ENHANCING REAL- WORLD EVIDENCE COLLECTION, PATIENT CENTRICITY, AND POST-MARKET STUDIES 75 Digital Health Technologies for Post-Marketing Research and Surveillance, 76 Use of Digital Health Technologies to Empower Patient Participation, 79 Clinician Perspective on Digital Health Technologies for Post- Marketing Research and Surveillance, 84 7 REFLECTIONS AND KEY TAKEAWAYS 87 Challenges Associated with the Use of Digital Health Technologies, 87 Digital Health Technologies to Enable Patient-Centered Drug Development, 88 Standards and Evaluation Frameworks, 89 “Pain Points” Across the Drug Development Process and Solutions Digital Health Technologies Can Provide, 90 REFERENCES 93 PREPUBLICATION COPY—Uncorrected Proofs

CONTENTS xvii APPENDIXES A WORKSHOP STATEMENT OF TASK 99 B WORKSHOP AGENDA 101 C PLANNING COMMITTEE BIOGRAPHICAL SKETCHES 105 D WORKSHOP SPEAKER BIOGRAPHICAL SKETCHES 113 PREPUBLICATION COPY—Uncorrected Proofs

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Boxes, Figures, and Table BOXES 2-1 Digital Health Technology Methods, 7 3-1 Guiding Questions for Evaluating the Scientific Value of a Data Type, 30 3-2 Evidation Health’s Achievement Program, 36 4-1 21st Century Cures Section 3011 Drug Development Tool Qualification, 44 4-2 Evaluation of Digital Health Technology for Cardiovascular Moni- toring, 55 5-1 Verification and Validation of Digital Tools for Measuring Parkin- son’s Disease Severity, 67 6-1 Patient-Informed Measurement and Design Principles, 82 7-1 Standards Needed for Evaluating Digital Health Technologies, 89 FIGURES 2-1 Variability in regulation and training among diverse stakeholders in the digital health research landscape, 13 2-2 Factors influencing ethical practices in digital health, 15 xix PREPUBLICATION COPY—Uncorrected Proofs

xx BOXES, FIGURES, AND TABLE 3-1 Sources of person-generated health data, 35 4-1 Conceptual framework for biomarker development for regulatory acceptance, 48 4-2 Telehealth-based learning health system during an infectious disease outbreak, 58 5-1 Conceptual map of technical and organizational capacity for bio- medical big data, 63 TABLE 2-1 Digital Health Technology Research and Information Gaps to Be Filled, 16 PREPUBLICATION COPY—Uncorrected Proofs

Acronyms and Abbreviations 3-MST 3-meter shuttle test 12-MRT 12-minute run test ADAU average daily accelerometry units 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 xxi PREPUBLICATION COPY—Uncorrected Proofs

xxii ACRONYMS AND ABBREVIATIONS 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 PREPUBLICATION COPY—Uncorrected Proofs

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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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