National Academies Press: OpenBook
Suggested Citation:"Front Matter." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
×

SHARING CLINICAL
RESEARCH DATA

WORKSHOP SUMMARY

Steve Olson and Autumn S. Downey, Rapporteurs

Forum on Drug Discovery, Development, and Translation
Forum on Neuroscience and Nervous System Disorders
National Cancer Policy Forum
Roundtable on Translating Genomic-Based Research for Health

Board on Health Sciences Policy
Board on Health Care Services

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.

www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
×

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

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.

This study was supported by contracts between the National Academy of Sciences and AbbVie, Alzheimer’s Association, American Academy of Nursing, American Association for Cancer Research, American Cancer Society, American College of Medical Genetics and Genomics, American Diabetes Association, American Heart Association, American Medical Association, American Society for Microbiology, American Society of Clinical Oncology, American Society of Human Genetics, Amgen Inc., Association of American Cancer Institutes, Association of American Medical Colleges, Blue Cross and Blue Shield Association, Bristol-Myers Squibb, Burroughs Wellcome Fund, C-Change, Celtic Therapeutics, LLLP, CeNeRx Biopharma, Centers for Disease Control and Prevention (Contract Nos. 200-2005-13434 and 200-2011-38807), CEO Roundtable on Cancer, College of American Pathologists, Critical Path Institute, Department of Health and Human Services (Contract Nos. N01-OD-4-2139 and HHSF22301026T), Department of Health and Human Services’ National Institutes of Health (NIH) (Contract No. N01-OD-4-2139) through the National Eye Institute, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute on Drug Abuse, and NIH Blueprint for Neuroscience Research, Department of the Air Force (Contract No. FA7014-10-P-0072), Department of Veterans Affairs (Contract No. V101(93) P-2238), Doris Duke Charitable Foundation, Eli Lilly and Company (Contract No. LRL-0028-07), Fast Forward, LLC, FasterCures, Foundation for the National Institutes of Health, Friends of Cancer Research, GE Healthcare, Inc., Genetic Alliance, GlaxoSmithKline, Health Resources and Services Administration (Contract No. HHSH250201100119P), Janssen Research & Development, LLC, Johnson & Johnson Pharmaceutical Research and Development, LLC, The Kaiser Permanente Program Offices Community Benefit II at the East Bay Community Foundation (Contract No. 20121257), Life Technologies, Lundbeck Research USA, March of Dimes Foundation, Merck & Co., Inc., Merck Research Laboratories, The Michael J. Fox Foundation for Parkinson’s Research, National Cancer Institute (Contract Nos. HHSN261200900003C and N01-OD-4-2139, TO#189), National Coalition for Health Professional Education in Genetics, National Heart, Lung, and Blood Institute (Contract No. N01-OD-4-2139, TO#275), National Human Genome Research Institute (Contract Nos. N01-OD-4-2139, TO#264 and HHSN263201200074I, TO#5), National Institute of Mental Health (Contract No. N01-OD-4-2139, TO#275), National Institute on Aging (Contract No. N01-OD-4-2139, TO#275), National Science Foundation (Contract No. OIA-0753701), National Society of Genetic Counselors, Northrop Grumman Health IT, Novartis Oncology, Novartis Pharmaceuticals Corporation, Office of Rare Diseases Research (Contract No. N01-OD-4-2139, TO#275), Oncology Nursing Society, One Mind for Research, Pfizer Inc. (Contract No. 140-N-1818071), Sanofi-Aventis, Society for Neuroscience, and Wellcome Trust. The views presented in this publication do not necessarily reflect the views of the organizations or agencies that provided support for the project.

International Standard Book Number-13: 978-0-309-26874-5
International Standard Book Number-10: 0-309-26874-5

Additional copies of this workshop summary are available for sale 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.

For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu.

Copyright 2013 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

Suggested citation: IOM (Institute of Medicine). 2013. Sharing clinical research data: Workshop summary. Washington, DC: The National Academies Press.

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
×

Knowing is not enough; we must apply.
Willing is not enough; we must do.

—Goethe

image

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

Advising the Nation. Improving Health.

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
×

THE NATIONAL ACADEMIES

Advisers to the Nation on Science, Engineering, and Medicine

The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences.

The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering.

The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine.

The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.

www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
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PLANNING COMMITTEE ON SHARING CLINICAL RESEARCH DATA: AN INSTITUTE OF MEDICINE WORKSHOP1

SHARON TERRY (Chair), Genetic Alliance, Washington, DC

JOSEPHINE P. BRIGGS, National Institutes of Health, Bethesda, MD

TIMOTHY COETZEE, National Multiple Sclerosis Society, New York, NY

STEVEN GOODMAN, Stanford University School of Medicine, CA

ROBERT A. HARRINGTON, Stanford University School of Medicine, CA

LYNN HUDSON, Critical Path Institute, Tucson, AZ

CHARLES HUGH-JONES, Sanofi-Aventis, Inc., Bridgewater, NJ

JAN JOHANNESSEN, U.S. Food and Drug Administration, Silver Spring, MD

JEFFREY S. NYE, Janssen Research & Development, LLC, Titusville, NJ

RICHARD PLATT, Harvard Medical School, Boston, MA

WILLIAM Z. POTTER, FNIH Biomarkers Consortium, Philadelphia, PA

FRANK W. ROCKHOLD, GlaxoSmithKline Pharmaceuticals Research and Development, King of Prussia, PA

MICHAEL ROSENBLATT, Merck & Co., Inc., Whitehouse Station, NJ

VICKI SEYFERT-MARGOLIS, U.S. Food and Drug Administration, Silver Spring, MD

DEBORAH A. ZARIN, National Institutes of Health, Bethesda, MD

IOM Staff

AUTUMN DOWNEY, Program Officer

CLARE STROUD, Program Officer

REBECCA A. ENGLISH, Associate Program Officer

CLAIRE GIAMMARIA, Research Associate

______________________

1Institute of Medicine planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution. Statements, recommendations, and opinions expressed are those of individual presenters and participants, and are not necessarily endorsed or verified by the Institute of Medicine, and they should not be construed as reflecting any group consensus.

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
×

FRANK VALLIERE, Research Associate

TONIA E. DICKERSON, Senior Program Assistant

CRYSTI PARK, Senior Program Assistant

BRUCE M. ALTEVOGT, Director, Forum on Neuroscience and Nervous System Disorders

ADAM C. BERGER, Director, Roundtable on Translating Genomic-Based Research for Health

ANNE B. CLAIBORNE, Director, Forum on Drug Discovery, Development, and Translation

ROGER HERDMAN, Director, Board on Health Care Services

SHARYL J. NASS, Director, National Cancer Policy Forum

ANDREW M. POPE, Director, Board on Health Sciences Policy

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
×

FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION1

JEFFREY M. DRAZEN (Co-Chair), New England Journal of Medicine, Boston, MA

STEVEN K. GALSON (Co-Chair), Amgen Inc., Thousand Oaks, CA

RUSS BIAGIO ALTMAN, Stanford University, CA

MARGARET ANDERSON, FasterCures, Washington, DC

CHRISTOPHER AUSTIN, National Center for Advancing Translational Sciences, Bethesda, MD

ANN BONHAM, Association of American Medical Colleges, Washington, DC

LINDA BRADY, National Institute of Mental Health, Bethesda, MD

GAIL H. CASSELL, Harvard Medical School (Visiting), Carmel, IN

PETER B. CORR, Celtic Therapeutics, LLLP, New York, NY

ANDREW M. DAHLEM, Eli Lilly and Company, Indianapolis, IN

TAMARA DARSOW, American Diabetes Association, Alexandria, VA

JAMES H. DOROSHOW, National Cancer Institute, Bethesda, MD

GARY L. FILERMAN, Atlas Health Foundation, McLean, VA

MARK J. GOLDBERGER, Abbott Pharmaceuticals, Rockville, MD

HARRY B. GREENBERG, Stanford University School of Medicine, CA

LYNN HUDSON, Critical Path Institute, Tucson, AZ

S. CLAIBORNE JOHNSTON, University of California, San Francisco

MICHAEL KATZ, March of Dimes Foundation, White Plains, NY

PETRA KAUFMANN, National Institute of Neurological Disorders and Stroke, Bethesda, MD

JACK D. KEENE, Duke University Medical Center, Durham, NC

RONALD L. KRALL, University of Pennsylvania Center for Bioethics, Steamboat Springs, CO

FREDA LEWIS-HALL, Pfizer Inc., New York, NY

CAROL MIMURA, University of California, Berkeley

BERNARD H. MUNOS, InnoThink Center for Research in Biomedical Innovation, Indianapolis, IN

ELIZABETH (BETSY) MYERS, Doris Duke Charitable Foundation, New York, NY

______________________

1Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

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JOHN ORLOFF, Novartis Pharmaceuticals Corporation, East Hanover, NJ

AMY PATTERSON, National Institutes of Health, Bethesda, MD

MICHAEL ROSENBLATT, Merck & Co., Inc., Whitehouse Station, NJ

JANET SHOEMAKER, American Society for Microbiology, Washington, DC

ELLEN SIGAL, Friends of Cancer Research, Washington, DC

ELLEN R. STRAHLMAN, GlaxoSmithKline, Research Triangle Park, NC

BRIAN L. STROM, University of Pennsylvania Perelman School of Medicine, Philadelphia

NANCY SUNG, Burroughs Wellcome Fund, Research Triangle Park, NC

JANET TOBIAS, Ikana Media and Mount Sinai School of Medicine, New York, NY

JOANNE WALDSTREICHER, Janssen Research & Development, LLC, Raritan, NJ

JANET WOODCOCK, U.S. Food and Drug Administration, White Oak, MD

IOM Staff

ANNE B. CLAIBORNE, Director, Forum on Drug Discovery, Development, and Translation

REBECCA A. ENGLISH, Associate Program Officer

ELIZABETH F. C. TYSON, Research Associate

ROBIN GUYSE, Senior Program Assistant

ANDREW M. POPE, Director, Board on Health Sciences Policy

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
×

FORUM ON NEUROSCIENCE AND NERVOUS SYSTEM DISORDERS1

STEVEN HYMAN (Chair), The Broad Institute, Cambridge, MA

SUSAN AMARA, University of Pittsburgh School of Medicine, PA

MARC BARLOW, GE Healthcare, Inc., Chalfont St. Giles, United Kingdom

MARK BEAR, Massachusetts Institute of Technology, Cambridge, MA

KATJA BROSE, Neuron, San Francisco, CA

DANIEL BURCH, CeNeRx Biopharma, Morrisville, NC

C. THOMAS CASKEY, Baylor College of Medicine, Houston, TX

TIMOTHY COETZEE, National Multiple Sclerosis Society, New York, NY

EMMELINE EDWARDS, National Institutes of Health Neuroscience Blueprint, Bethesda, MD

MARTHA FARAH, University of Pennsylvania, Philadelphia

RICHARD FRANK, GE Healthcare, Inc., Princeton, NJ

DANIEL GESCHWIND, University of California, Los Angeles

HANK GREELY, Stanford University, CA

MYRON GUTMANN, National Science Foundation, Arlington, VA

RICHARD HODES, National Institute on Aging, Bethesda, MD

THOMAS INSEL, National Institute of Mental Health, Bethesda, MD

PHILLIP IREDALE, Pfizer Global Research and Development, Groton, CT

DANIEL JAVITT, Nathan S. Kline Institute for Psychiatric Research, Orangeburg, NY

FRANCES JENSEN, University of Pennsylvania School of Medicine, Philadelphia

STORY LANDIS, National Institute of Neurological Disorders and Stroke, Bethesda, MD

ALAN LESHNER, American Association for the Advancement of Science, Washington, DC

HUSSEINI MANJI, Johnson & Johnson Pharmaceutical Research and Development, Inc., Titusville, NJ

DAVID MICHELSON, Merck Research Laboratories, North Wales, PA

______________________

1Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
×

RICHARD MOHS, Lilly Research Laboratories, Indianapolis, IN

ALEXANDER OMMAYA, U.S. Department of Veterans Affairs, Washington, DC

ATUL PANDE, GlaxoSmithKline, Inc., Research Triangle, NC

STEVEN PAUL, Weill Cornell Medical College, New York, NY

TODD SHERER, Michael J. Fox Foundation for Parkinson’s Research, New York, NY

PAUL SIEVING, National Institutes of Health, Bethesda, MD

JUDITH SIUCIAK, Foundation for the National Institutes of Health, Bethesda, MD

MARC TESSIER-LAVIGNE, The Rockefeller University, New York, NY

WILLIAM THIES, Alzheimer’s Association, Chicago, IL

NORA VOLKOW, National Institute on Drug Abuse, Bethesda, MD

KENNETH WARREN, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD

JOHN WILLIAMS, Wellcome Trust, London, United Kingdom

STEVIN ZORN, Lundbeck USA, Paramus, NJ

CHARLES ZORUMSKI, Washington University School of Medicine

IOM Staff

BRUCE M. ALTEVOGT, Director, Forum on Neuroscience and Nervous System Disorders

DIANA E. PANKEVICH, Program Officer

ELIZABETH K. THOMAS, Senior Program Assistant

ANDREW M. POPE, Director, Board on Health Sciences Policy

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
×

NATIONAL CANCER POLICY FORUM1

JOHN MENDELSOHN (Chair), MD Anderson Cancer Center, Houston, TX

PATRICIA A. GANZ (Vice Chair), University of California, Los Angeles

AMY P. ABERNETHY, Duke University School of Medicine, Durham, NC

RAFAEL G. AMADO, GlaxoSmithKline-Oncology, Collegeville, PA

FRED APPELBAUM, Fred Hutchinson Cancer Research Center, Seattle, WA

PETER B. BACH, Memorial Sloan-Kettering Cancer Center, New York, NY

EDWARD BENZ, JR., Harvard School of Medicine, Boston, MA

MONICA BERTAGNOLLI, Harvard University Medical School, Boston, MA

OTIS BRAWLEY, American Cancer Society, Atlanta, GA

MICHAEL A. CALIGIURI, Ohio State University, Columbus

RENZO CANETTA, Bristol-Myers Squibb, Wallingford, CT

MICHAELE CHAMBLEE CHRISTIAN, Retired, Washington, DC

WILLIAM DALTON, Moffitt Cancer Center, Tampa, FL

WENDY DEMARK-WAHNEFRIED, University of Alabama at Birmingham

ROBERT ERWIN, Marti Nelson Cancer Foundation, Davis, CA

ROY S. HERBST, Yale Cancer Center, New Haven, CT

THOMAS J. KEAN, C-Change, Washington, DC

MICHELLE LE BEAU, University of Chicago, IL

DOUGLAS R. LOWY, National Cancer Institute, Bethesda, MD

DANIEL R. MASYS, University of Washington, Seattle, WA

MARTIN J. MURPHY, Roundtable on Cancer, Durham, NC

BRENDA NEVIDJON, Duke University School of Nursing, Durham, NC

STEVEN PIANTADOSI, Cedars-Sinai Medical Center, Los Angeles, CA

______________________

1Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
×

LISA C. RICHARDSON, Centers for Disease Control and Prevention, Atlanta, GA

DEBASISH ROYCHOWDHURY, Sanofi Oncology, Cambridge, MA

YA-CHEN TINA SHIH, University of Chicago, IL

ELLEN SIGAL, Friends of Cancer Research, Washington, DC

STEVEN STEIN, Novartis Oncology, East Hanover, NJ

JOHN A. WAGNER, Merck and Company, Inc., Rahway, NJ

RALPH R. WEICHSELBAUM, University of Chicago, IL

JANET WOODCOCK, U.S. Food and Drug Administration, Rockville, MD

IOM Staff

SHARYL J. NASS, Director, National Cancer Policy Forum

LAURA LEVIT, Program Officer

ERIN BALOGH, Associate Program Officer

PAMELA LIGHTER, Research Assistant

MICHAEL PARK, Senior Program Assistant

PATRICK BURKE, Financial Associate

SHARON B. MURPHY, Scholar in Residence

ROGER HERDMAN, Director, Board on Health Care Services

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ROUNDTABLE ON TRANSLATING GENOMIC-BASED RESEARCH FOR HEALTH1

WYLIE BURKE (Co-Chair), University of Washington, Seattle

SHARON TERRY (Co-Chair), Genetic Alliance, Washington, DC

NAOMI ARONSON, Blue Cross and Blue Shield Association, Chicago, IL

EUAN ANGUS ASHLEY, Stanford University School of Medicine, Palo Alto, CA

PAUL R. BILLINGS, Life Technologies, Carlsbad, CA

BRUCE BLUMBERG, The Permanente Medical Group, Oakland, CA

DENISE E. BONDS, National Heart, Lung, and Blood Institute, Bethesda, MD

PHILIP J. BROOKS, National Center for Advancing Translational Research, Rockville, MD

C. THOMAS CASKEY, Baylor College of Medicine, Houston, TX

SARA COPELAND, Health Resources and Services Administration, Rockville, MD

MICHAEL J. DOUGHERTY, American Society of Human Genetics, Bethesda, MD

VICTOR DZAU, Duke University, Durham, NC

W. GREGORY FEERO, Journal of the American Medical Association, Chicago, IL

ANDREW N. FREEDMAN, National Cancer Institute, Rockville, MD

GEOFFREY GINSBURG, Duke University, Durham, NC

RICHARD J. HODES, National Institute on Aging, Bethesda, MD

SHARON KARDIA, University of Michigan School of Public Health, Ann Arbor

MOHAMED KHAN, BC Cancer Agency, Vancouver, British Columbia, Canada

MUIN KHOURY, Centers for Disease Control and Prevention, Atlanta, GA

THOMAS LEHNER, National Institute of Mental Health, Bethesda, MD

______________________

1Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
×

DEBRA LEONARD, Weill Cornell Medical Center of Cornell University, New York, NY

ELIZABETH MANSFIELD, U.S. Food and Drug Administration, Silver Spring, MD

KELLY MCVEARRY, Northrop Grumman Information Systems, Rockville, MD

GARRY NEIL, Johnson & Johnson, New Brunswick, NJ

ROBERT L. NUSSBAUM, University of California, San Francisco, School of Medicine

MICHELLE A. PENNY, Eli Lilly and Company, Indianapolis, IN

AIDAN POWER, Pfizer Inc., Groton, CT

VICTORIA M. PRATT, Quest Diagnostics Nichols Institute, Chantilly, VA

RONALD PRZYGODZKI, Department of Veterans Affairs, Washington, DC

ALLEN D. ROSES, Cabernet, Shiraz and Zinfandel Pharmaceuticals; Duke University, Durham, NC

KEVIN A. SCHULMAN, Duke University School of Medicine, Durham, NC

JOAN A. SCOTT, National Coalition for Health Professional Education in Genetics, Lutherville, MD

DAVID VEENSTRA, University of Washington, Seattle

MICHAEL S. WATSON, American College of Medical Genetics and Genomics, Bethesda, MD

DANIEL WATTENDORF, DARPA/Defense Sciences Office, Arlington, VA

CATHERINE A. WICKLUND, Northwestern University, Chicago, IL

IOM Staff

ADAM C. BERGER, Director, Roundtable on Translating Genomic-Based Research for Health

SEAN P. DAVID, James C. Puffer, M.D./American Board of Family Medicine Fellow

TONIA E. DICKERSON, Senior Program Assistant

ANDREW M. POPE, Director, Board on Health Sciences Policy

Suggested Citation:"Front Matter." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
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Reviewers

This workshop summary has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published summary as sound as possible and to ensure that the summary meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this workshop summary:

William W. Chin, Harvard Medical School

Carolyn Compton, Critical Path Institute

Barry Gertz, Affairs, Merck Research Laboratories

Jeffrey Nye, Janssen Research & Development, LLC

Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the workshop summary before its release. The review of this summary was overseen by Melvin Worth, Jr. Appointed by the Institute of Medicine, he was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this summary rests entirely with the authors and the institution.

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Acronyms

BRIDG

Biomedical Research Integrated Domain Group

 

 

CAMD

Coalition Against Major Diseases

CDA

clinical documentation architecture

CDASH

Clinical Data Acquisition Standards Harmonization

CDE

common data element

CDER

Center for Drug Evaluation and Research

CDISC

Clinical Data Interchange Standards Consortium

CEO

chief executive officer

CFAST

Coalition for Accelerating Standards and Therapies

CLIA

Clinical Laboratory Improvement Amendments

C-Path

Critical Path Institute

CSR

clinical study report

 

 

eDISH

Electronic Drug-Induced Serious Hepatoxicity

EHR

electronic health record

EMA

European Medicines Agency

 

 

FDA

Food and Drug Administration

FDASIA

FDA Safety and Innovation Act

FNIH

Foundation for the National Institutes of Health

FTC

Federal Trade Commission

 

 

HHMI

Howard Hughes Medical Institute

HIPAA

Health Insurance Portability and Accountability Act

HL7

Health Level 7 International

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iDASH

Integrated Data for Analysis, Anonymization, and Sharing

IHE

Integrating the Healthcare Enterprise

IOM

Institute of Medicine

IRB

institutional review board

 

 

NDA

new drug application

NEWMEDS

Novel Methods for Development of Drugs in Depression and Schizophrenia

 

 

NHLBI

National Heart, Lung, and Blood Institute

NIH

National Institutes of Health

NINDS

National Institute of Neurological Disorders and Stroke

NSF

National Science Foundation

 

 

PDUFA

Prescription Drug User Fee Act

PHI

protected health information

 

 

SDO

standards development organization

SDTM

Study Data Tabulation Model

 

 

YODA

Yale University Open Data Access

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Pharmaceutical companies, academic researchers, and government agencies such as the Food and Drug Administration and the National Institutes of Health all possess large quantities of clinical research data. If these data were shared more widely within and across sectors, the resulting research advances derived from data pooling and analysis could improve public health, enhance patient safety, and spur drug development. Data sharing can also increase public trust in clinical trials and conclusions derived from them by lending transparency to the clinical research process. Much of this information, however, is never shared. Retention of clinical research data by investigators and within organizations may represent lost opportunities in biomedical research. Despite the potential benefits that could be accrued from pooling and analysis of shared data, barriers to data sharing faced by researchers in industry include concerns about data mining, erroneous secondary analyses of data, and unwarranted litigation, as well as a desire to protect confidential commercial information. Academic partners face significant cultural barriers to sharing data and participating in longer term collaborative efforts that stem from a desire to protect intellectual autonomy and a career advancement system built on priority of publication and citation requirements. Some barriers, like the need to protect patient privacy, pre- sent challenges for both sectors. Looking ahead, there are also a number of technical challenges to be faced in analyzing potentially large and heterogeneous datasets.

This public workshop focused on strategies to facilitate sharing of clinical research data in order to advance scientific knowledge and public health. While the workshop focused on sharing of data from preplanned interventional studies of human subjects, models and projects involving sharing of other clinical data types were considered to the extent that they provided lessons learned and best practices. The workshop objectives were to examine the benefits of sharing of clinical research data from all sectors and among these sectors, including, for example: benefits to the research and development enterprise and benefits to the analysis of safety and efficacy. Sharing Clinical Research Data: Workshop Summary identifies barriers and challenges to sharing clinical research data, explores strategies to address these barriers and challenges, including identifying priority actions and "low-hanging fruit" opportunities, and discusses strategies for using these potentially large datasets to facilitate scientific and public health advances.

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