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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

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Washington, DC
www.nap.edu

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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This activity was supported by contracts between the National Academy of Sciences 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 (Contract 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 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; 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 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: 978-0-309-67915-2
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Suggested citation: 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. https://doi.org/10.17226/25838.

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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PLANNING COMMITTEE ON SHARING CLINICAL TRIAL DATA: CHALLENGES AND A WAY FORWARD1

JEFFREY M. 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 Corporation

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 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. 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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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 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. 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.
×

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

Page viii Cite
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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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

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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JOSEPH P. 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

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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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

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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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

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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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

Page xiii Cite
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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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

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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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:

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 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. 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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Page xvii Cite
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.
×

Acknowledgments

Sponsorship from the Wellcome Trust helped make this workshop possible. Support from the sponsors of the National Academies of Sciences, Engineering, and Medicine’s Forum on Drug Discovery, Development, 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 committee 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.

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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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Acronyms and Abbreviations

ACCENT Adjuvant Colon Cancer End Points
ADaM CDISC Analysis Data Model
ALS amyotrophic lateral sclerosis
APC Adenoma Prevention with Celecoxib
APPROVe Adenomatous Polyp Prevention on Vioxx Trial
BMS Bristol-Myers Squibb
BRIDG Biomedical Research Integrated Domain Group
CARE Collective benefit, Authority to control, Responsibility, and Ethics
CDISC Clinical Data Interchange Standards Consortium
CSDR ClinicalStudyDataRequest.com
CTSU Clinical Trial Services Unit and Epidemiological Studies Unit
CTT Cholesterol Treatment Trialists’ Collaboration
dbGaP database of Genotypes and Phenotypes (National Center for Biotechnology Information)
DCRI Duke Clinical Research Institute
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
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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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FAIR findable, accessible, interoperable, and reusable
FDA U.S. Food and Drug Administration
FHIR Fast Healthcare Interoperability Resources
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
IRB institutional review board
IRP independent review panel
ITT intention to treat
LDL low-density lipoprotein
MIT Massachusetts Institute of Technology
MRC Medical Research Council (United Kingdom)
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
SDMC Statistics and Data Management Center
SDTM CDISC Study Data Tabulation Model
SOAR Supporting Open Access for Researchers
SPRINT Systolic Blood Pressure Intervention Trial
TRS Trial Reporting System
TSC Trial Steering Committee
UCL University College London
WHO World Health Organization
WWARN WorldWide Antimalarial Resistance Network
YODA Yale University Open Data Access Project
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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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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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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