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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25838.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25838.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25838.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25838.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25838.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25838.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25838.
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Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward PROCEEDINGS OF A WORKSHOP Theresa Wizemann, Eeshan Khandekar, Jennifer Hinners, and Carolyn Shore, Rapporteurs Forum on Drug Discovery, Development, and Translation Forum on Neuroscience and Nervous System Disorders National Cancer Policy Forum Roundtable on Genomics and Precision Health Board on Health Sciences Policy Board on Health Care Services 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 S ­ ciences and AbbVie Inc.; Amgen Inc. (Contract No. GHCCOPS-CSARF-175837); Association of American Medical Colleges; AstraZeneca; Burroughs Wellcome Fund (Contract No. 1020264); Critical Path Institute; Eli Lilly and Company (Con- tract No. 4900709231); FasterCures, Milken Institute; Foundation for the National Institutes of Health; Friends of Cancer Research; GlaxoSmithKline (Contract No. OTH-PPL-30507 and Contract No. OTH-PPL-32245); Johnson & Johnson; Merck & Co., Inc. (Contract No. MRLCPO-18-2641 and Contract No. MRLCPO-19-106723); National Institutes of Health (Contract No. HHSN263201800029I; Task Order No. HHSN26300007): 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 Neurological Disorders and Stroke, Office of Extramural Research, Office of Science Policy; New England Journal of Medicine; Takeda Pharmaceuticals (Contract No. 53108); U.S. Food and Drug Administration (Grant No. 5R13FD005496-04 and Grant No. 5R13FD005496- 05); and Wellcome Trust. Any opinions, findings, conclusions, or recommenda- tions 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/10.17226/25838 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 Medicine. ­ 2020. Reflections on sharing clinical trial data: Challenges and a way forward: ­ roceedings P of a workshop. Washington, DC: The National Academies Press. https://doi. org/10.17226/25838. 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 ON SHARING CLINICAL TRIAL DATA: CHALLENGES AND A WAY FORWARD1 JEFFREY DRAZEN (Co-Chair), New England Journal of Medicine JOANNE WALDSTREICHER (Co-Chair), Johnson & Johnson MONICA BERTAGNOLLI, Harvard Medical School; Dana-Farber Cancer Institute and Brigham and Women’s Hospital TIMOTHY COETZEE, National Multiple Sclerosis Society PATRICK CULLINAN, Bluebird Bio SONALI KOCHHAR, Global Healthcare Consulting; University of Washington; Erasmus MC, University Medical Center BERNARD LO, The Greenwall Foundation DEVEN McGRAW, Ciitizen DINA PALTOO, National Library of Medicine, National Institutes of Health LIZ ROBERTS, UCB Biosciences, Inc. FRANK ROCKHOLD, Duke University Medical Center SHARON TERRY, Genetic Alliance DEBORAH ZARIN, Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard Health and Medicine Division Staff CAROLYN SHORE, Director, Forum on Drug Discovery, Development, and Translation JENNIFER HINNERS, Program Officer EESHAN KHANDEKAR, Associate Program Officer MELVIN JOPPY, Senior Program Assistant ANDREW M. POPE, Senior Director, Board on Health Sciences Policy Consultant THERESA WIZEMANN, Science Writer 1 The National Academies of Sciences, Engineering, and Medicine’s planning ­ ommittees c 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 r ­ apporteurs 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 CHRISTOPHER P. AUSTIN, National Center for Advancing Translational Sciences LINDA BRADY, National Institute of Mental Health BARRY COLLER, The Rockefeller University THOMAS CURRAN, Children’s Mercy, Kansas City RICHARD DAVEY, National Institute of Allergy and Infectious Diseases 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. DEBORAH HUNG, Harvard Medical School ESTHER KROFAH, FasterCures, Milken Institute ROSS McKINNEY, JR., Association of American Medical Colleges JOSEPH P. MENETSKI, Foundation for the National Institutes of Health BERNARD H. MUNOS, InnoThink Center for Research in Biomedical Innovation KELLY ROSE, Burroughs Wellcome Fund JOSEPH SCHEEREN, Critical Path Institute ROB SCOTT, AbbVie Inc. ANANTHA SHEKHAR, Indiana University School of Medicine ELLEN V. SIGAL, Friends of Cancer Research LANA R. SKIRBOLL, Sanofi AMIR TAMIZ, National Institute of Neurological Disorders and Stroke PAMELA TENAERTS, Clinical Trials Transformation Initiative, Duke University JOANNE WALDSTREICHER, Johnson & Johnson CARRIE WOLINETZ, Office of Science Policy, National Institutes of Health ALASTAIR WOOD, Vanderbilt University JANET WOODCOCK, U.S. Food and Drug 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. vi PREPUBLICATION COPY—Uncorrected Proofs

Forum Staff CAROLYN SHORE, Forum Director JENNIFER HINNERS, Program Officer AMANDA WAGNER GEE, Program Officer EESHAN KHANDEKAR, Associate Program Officer SYLVIA NCHA, Associate Program Officer MELVIN JOPPY, Senior Program Assistant ANDREW M. POPE, Senior Director, Board on Health Sciences Policy vii PREPUBLICATION COPY—Uncorrected Proofs

FORUM ON NEUROSCIENCE AND NERVOUS SYSTEM DISORDERS FRANCES JENSEN (Co-Chair), University of Pennsylvania JOHN KRYSTAL (Co-Chair), Yale University SUSAN AMARA, Society for Neuroscience RITA BALICE-GORDON, Sanofi KATJA BROSE, Chan Zuckerberg Initiative EMERY BROWN, Harvard Medical School and Massachusetts Institute of Technology DANIEL BURCH, Pharmaceutical Product Development, LLC JOSEPH BUXBAUM, Icahn School of Medicine at Mount Sinai SARAH CADDICK, Gatsby Charitable Foundation ROSA CANET-AVILES, Foundation for the National Institutes of Health MARIA CARRILLO, Alzheimer’s Association EDWARD CHANG, University of California, San Francisco TIMOTHY COETZEE, National Multiple Sclerosis Society JONATHAN COHEN, Princeton University ROBERT CONLEY, Eli Lilly and Company JAMES DESHLER, National Science Foundation BILLY DUNN, U.S. Food and Drug Administration MICHAEL EGAN, Merck Research Laboratories NITA FARAHANY, Duke University School of Law JOSHUA GORDON, National Institute of Mental Health RAQUEL GUR, University of Pennsylvania MAGALI HAAS, Cohen Veterans Bioscience RAMONA HICKS, One Mind RICHARD HODES, National Institute on Aging STUART HOFFMAN, U.S. Department of Veterans Affairs JONATHAN HORSFORD, National Institute of Dental and Craniofacial Research YASMIN HURD, Icahn School of Medicine at Mount Sinai STEVEN HYMAN, Broad Institute of Massachusetts Institute of Technology and Harvard University MICHAEL IRIZARRY, Eisai Inc. GEORGE KOOB, National Institute on Alcohol Abuse and Alcoholism WALTER KOROSHETZ, National Institute of Neurological Disorders and Stroke STORY LANDIS, Director Emeritus, National Institute of Neurological Disorders and Stroke ALAN LESHNER, American Association for the Advancement of Science (Emeritus) HUSSEINI MANJI, Janssen Research & Development, LLC viii PREPUBLICATION COPY—Uncorrected Proofs

JOSEPH MENETSKI, Foundation for the National Institutes of Health CAROLINE MONTOJO, The Kavli Foundation STEVEN PAUL, Voyager Therapeutics EMILIANGELO RATTI, Takeda Pharmaceuticals International TODD SHERER, The Michael J. Fox Foundation for Parkinson’s Research DAVID SHURTLEFF, National Center for Complementary and Integrative Health SANTA TUMMINIA, National Eye Institute NORA VOLKOW, National Institute on Drug Abuse ANDREW WELCHMAN, Wellcome Trust DOUG WILLIAMSON, Lundbeck STEVIN ZORN, MindImmune Therapeutics, Inc. Forum Staff CLARE STROUD, Forum Director SHEENA M. POSEY NORRIS, Program Officer PHOENIX WILSON, Senior Program Assistant ANDREW M. POPE, Senior Director, Board on Health Sciences Policy ix PREPUBLICATION COPY—Uncorrected Proofs

NATIONAL CANCER POLICY FORUM EDWARD J. BENZ, JR. (Chair), Dana-Farber Cancer Institute and Harvard Medical School GARNET L. ANDERSON, Fred Hutchinson Cancer Research Center and University of Washington KENNETH ANDERSON, American Cancer Society and Jerome Lipper Multiple Myeloma Center KAREN BASEN-ENGQUIST, The University of Texas MD Anderson Cancer Center LINDA BOHANNON, Cancer Support Community CHRIS BOSHOFF, Pfizer Inc. CATHY J. BRADLEY, Colorado School of Public Health and University of Colorado Cancer Center OTIS W. BRAWLEY, Johns Hopkins University CYNTHIA BROGDON, Bristol-Myers Squibb Company ROBERT W. CARLSON, National Comprehensive Cancer Network GWEN DARIEN, National Patient Advocate Foundation NANCY E. DAVIDSON, Seattle Cancer Care Alliance; Fred Hutchinson Cancer Research Center; and University of Washington GEORGE D. DEMETRI, Harvard Medical School; Dana-Farber Cancer Institute; and Dana-Farber/Harvard Cancer Center JAMES H. DOROSHOW, National Cancer Institute NICOLE F. DOWLING, Centers for Disease Control and Prevention SCOT W. EBBINGHAUS, Merck Research Laboratories KOJO S. J. ELENITOBA-JOHNSON, University of Pennsylvania STANTON L. GERSON, Case Western Reserve University and University Hospitals Seidman Cancer Center LORI HOFFMAN HÖGG, U.S. Department of Veterans Affairs HEDVIG HRICAK, Memorial Sloan Kettering Cancer Center ERIN HUFMAN, Novartis Oncology ROY A. JENSEN, Association of American Cancer Institutes; The University of Kansas Cancer Center; and Kansas Masonic Cancer Research Institute LISA KENNEDY SHELDON, Oncology Nursing Society SAMIR N. KHLEIF, Georgetown University Medical Center MICHELLE M. LE BEAU, University of Chicago Medicine Comprehensive Cancer Center MIA LEVY, Rush University Cancer Center and Rush System for Health J. LEONARD LICHTENFELD, American Cancer Society NEAL J. MEROPOL, Flatiron Health MARTIN J. MURPHY, CEO Roundtable on Cancer x PREPUBLICATION COPY—Uncorrected Proofs

RANDALL A. OYER, Penn Medicine Lancaster General Health RICHARD L. SCHILSKY, American Society of Clinical Oncology JULIE SCHNEIDER, U.S. Food and Drug Administration DEBORAH SCHRAG, Harvard Medical School and Dana-Farber Cancer Institute LAWRENCE N. SHULMAN, University of Pennsylvania DAN THEODORESCU, Cedars-Sinai Medical Center GEORGE J. WEINER, The University of Iowa ROBERT A. WINN, Virginia Commonwealth University Massey Cancer Center Forum Staff ERIN BALOGH, Senior Program Officer EMILY ZEVON, Associate Program Officer CYNDI TRANG, Research Associate KATE HAWTHORNE, Senior Program Assistant ANNALEE GONZALES, Administrative Assistant ADEGBOYEGA AKINSIKU, Mirzayan Fellow SHARYL NASS, Director, National Cancer Policy Forum, and Senior Director, Board on Health Care Services xi PREPUBLICATION COPY—Uncorrected Proofs

ROUNDTABLE ON GENOMICS AND PRECISION HEALTH GEOFFREY GINSBURG (Co-Chair), Duke University MICHELLE PENNY (Co-Chair), Biogen NAOMI ARONSON, Blue Cross Blue Shield Association ARIS BARIS, Regeneron Pharmaceuticals KARINA BIENFAIT, Merck & Co., Inc. VENCE BONHAM, National Human Genome Research Institute ANN CASHION, National Institute of Nursing Research ROBERT B. DARNELL, The Rockefeller University 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 GILL, National Institute of Nursing Research MARC GRODMAN, Genosity JILL M. HAGENKORD, Color Genomics EMILY HARRIS, National Cancer Institute RICHARD HODES, National Institute on Aging PRADUMAN JAIN, Vibrent Health 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, The University of Vermont Medical Center PATRICK LOERCH, Johnson & Johnson JAMES LU, Helix SEAN McCONNELL, American Medical Association MONA MILLER, American Society of Human Genetics JENNIFER MOSER, U.S. Department of Veterans Affairs ANNA PETTERSSON, Pfizer Inc. VICTORIA 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 SAM SHEKAR, Northrop Grumman Information Systems NONNIEKAYE SHELBURNE, National Cancer Institute NIKOLETTA SIDIROPOULOS, The University of Vermont Health Network Medical Group KATHERINE JOHANSEN TABER, Myriad Women’s Health xii PREPUBLICATION COPY—Uncorrected Proofs

RYAN TAFT, Illumina JACQUELYN TAYLOR, New York University SHARON TERRY, Genetic Alliance JOYCE TUNG, 23andMe JAMESON VOSS, Air Force Medical Support Agency MICHAEL WATSON, American College of Medical Genetics and Genomics KAREN WECK, College of American Pathologists CATHERINE WICKLUND, National Society of Genetic Counselors HUNTINGTON F. WILLARD, Geisinger National Precision Health JANET WILLIAMS, American Academy of Nursing SARAH WORDSWORTH, University of Oxford ALICIA ZHOU, Color Genomics Roundtable Staff SARAH BEACHY, Senior Program Officer and Roundtable Director SIOBHAN ADDIE, Program Officer MEREDITH HACKMANN, Associate Program Officer MICHAEL BERRIOS, Senior Program Assistant ANDREW M. POPE, Senior Director, Board on Health Sciences Policy xiii 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: TIMOTHY COETZEE, National Multiple Sclerosis Society ALEXA T. McCRAY, Harvard Medical School JOHN ORLOFF, Alexion 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 DANIEL MASYS, University of Washington. He was responsible for making certain that an indepen- dent 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. xv PREPUBLICATION COPY—Uncorrected Proofs

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Acknowledgments Sponsorship from the Wellcome Trust helped make this workshop possible. Support from the sponsors of the National Academies of S ­ ciences, Engineering, and Medicine’s Forum on Drug Discovery, Devel- opment, and Translation; Forum on Neuroscience and Nervous System Disorders; National Cancer Policy Forum; and Roundtable on Genomics and Precision Health is crucial to support this and other work of the National Academies. The National Academies staff wish to express their gratitude to the speakers whose presentations helped inform workshop discussions on the state of clinical trial data sharing; to the members of the planning com- mittee for their work in developing the workshop agenda and shaping the discussions; and to the many other National Academies staff without whom this workshop and the accounting thereof would not have been possible: Jeanay Butler, Robert Day, Sadaf Faraz, Greta Gorman, Anna Isabel Camilo Javier, Bardia Massoudkhan, Bettina Seliber, Lauren Shern, Victor Stewart, and Taryn Young. xvii PREPUBLICATION COPY—Uncorrected Proofs

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Contents ACRONYMS AND ABBREVIATIONS xxv 1 INTRODUCTION 1 Revisiting the 2015 Institute of Medicine Consensus Study Report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, 3 Progress Made in Clinical Trial Data Sharing Since the 2015 Institute of Medicine Consensus Study Report, 3 Organization of the Workshop and Proceedings, 7 2 PERSPECTIVES ON CURRENT DATA-SHARING POLICIES IN PRACTICE 9 Researcher Perspective, 10 Patient Perspective, 12 Independent Panel Review Perspective, 14 Funder Perspective, 16 3 DATA-SHARING PLATFORMS 21 Vivli, 22 The YODA Project, 25 SOAR, 28 ClinicalStudyDataRequest.com, 31 xix PREPUBLICATION COPY—Uncorrected Proofs

xx CONTENTS 4 STRIKING A BALANCE BETWEEN BENEFIT/VALUE AND RISK/COST 35 Data Analyst Perspective, 36 Publisher Perspective, 39 Patient Perspective, 42 Discussion, 43 5 DATA INTEROPERABILITY AND PLATFORM USABILITY 47 Working with Population Data, 48 Challenges for Meta-Analysis, 51 Platform Perspective, 53 Discussion, 56 6 INFRASTRUCTURE SUSTAINABILITY 61 Funder Perspective, 62 Industry Perspective, 65 Platform Perspective, 68 Discussion, 70 7 CHALLENGES AND DISINCENTIVES FOR SHARING AND REUSE OF DATA 75 Researcher Perspective, 76 Sponsor Perspective, 81 Patient Perspective, 82 Discussion, 84 8 FINDING VALUE IN SHARING CLINICAL TRIAL DATA: OVERCOMING USABILITY AND SUSTAINABILITY CHALLENGES 87 Data User Perspective, 89 Data Generator/Sharer Perspective, 91 Platform Perspective, 94 Discussion, 95 9 LOOKING FORWARD: INCENTIVIZING DATA SHARING AND REUSE 101 Sponsor Perspective, 102 Researcher Perspective, 105 Institutional Perspective, 109 Funder Perspective, 112 Discussion, 115 Closing Remarks: Finding Value as We Move Forward, 118 PREPUBLICATION COPY—Uncorrected Proofs

CONTENTS xxi APPENDIXES A REFERENCES 121 B WORKSHOP AGENDA 125 PREPUBLICATION COPY—Uncorrected Proofs

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Boxes and Figures BOXES 1-1 Workshop Statement of Task, 2 1-2 Recommendations from the 2015 Institute of Medicine Consensus Study Report Sharing Clinical Trial Data: Maximizing Benefits, M ­ inimizing Risk, 4 2-1 Independent Review Panel Perspective: Suggestions to Enhance Data Sharing, 17 3-1 Goals and Principles of Open Science at the Duke University School of Medicine, 29 6-1 Proactive Clinical Trial Data Sharing by Lilly, 66 FIGURES 1-1 Functions of the Trial Reporting System, 6 3-1 Status of data requests by quarter (as of November 1, 2019), 27 3-2 The desired future state is one in which the benefits of data sharing clearly outweigh the barriers, 31 5-1 Minority recruitment to clinical trials, 50 5-2 Project Data Sphere funded data-to-research programs, 54 xxiii PREPUBLICATION COPY—Uncorrected Proofs

xxiv BOXES AND FIGURES 6-1 Cost of sharing, 63 6-2 Increasing demand for access to study data in the National Heart, Lung, and Blood Institute data repository, 69 7-1 Oversight and timing of data release requests, 79 8-1 Representation of the data-sharing environment, 88 9-1 Learning from shared clinical trial data, 106 PREPUBLICATION COPY—Uncorrected Proofs

Acronyms and Abbreviations BRIDG Biomedical Research Integrated Domain Group CDISC Clinical Data Interchange Standards Consortium CRF case report form CSDR ClinicalStudyDataRequest.com CSR clinical study report dbGaP database of Genotypes and Phenotypes (NCBI) DCRI Duke Clinical Research Institute DOI digital object identifier DSA data sharing agreement (used interchangeably with DUA) DSMB Data and Safety Monitoring Board DUA data use agreement (used interchangeably with DSA) EHR electronic health record FAIR findable, accessible, interoperable, and reusable FDA U.S. Food and Drug Administration ICMJE International Committee of Medical Journal Editors ICTRP International Clinical Trials Registry Platform (WHO) IDDO Infectious Diseases Data Observatory IOM Institute of Medicine IPD individual participant data or individual patient data xxv PREPUBLICATION COPY—Uncorrected Proofs

xxvi ACRONYMS AND ABBREVIATIONS IRB institutional review board IRP independent review panel LMIC low- and middle-income country MIT Massachusetts Institute of Technology MRC Medical Research Council (United Kingdom) NCBI National Center for Biotechnology Information NCI National Cancer Institute NCORP NCI Community Oncology Research Program NCTN National Clinical Trials Network (NCI) NHLBI National Heart, Lung, and Blood Institute (NIH) NIH National Institutes of Health NMA network meta-analysis PEER Platform for Engaging Everyone Responsibly SOAR Supporting Open Access for Researchers SPRINT Systolic Blood Pressure Intervention Trial UCSF University of California, San Francisco WHO World Health Organization WWARN WorldWide Antimalarial Resistance Network YODA Yale University Open Data Access Project PREPUBLICATION COPY—Uncorrected Proofs

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On November 18 and 19, 2019, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop in Washington, DC, titled Sharing Clinical Trial Data: Challenges and a Way Forward. The workshop followed the release of the 2015 Institute of Medicine (IOM) consensus study report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, and was designed to examine the current state of clinical trial data sharing and reuse and to consider ways in which policy, technology, incentives, and governance could be leveraged to further encourage and enhance data sharing. This publication summarizes the presentations and discussions from the workshop.

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