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Suggested Citation:"Front Matter." Institute of Medicine. 2012. Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13237.
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PUBLIC ENGAGEMENT
AND CLINICAL TRIALS

NEW MODELS AND DISRUPTIVE TECHNOLOGIES

WORKSHOP SUMMARY

Victoria Weisfeld, Rebecca A. English, and
Anne B. Claiborne, Rapporteurs

Forum on Drug Discovery, Development, and Translation

Board on Health Sciences Policy

INSTITUTE OF MEDICINE
              OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13237.
×

THE NATIONAL ACADEMIES PRESS   500 Fifth Street, N.W.   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 Department of Health and Human Services (Contract Nos. N01-OD-4-2139 TO No. 158 and HHSF223001003T), American Society for Microbiology; Amgen Inc.; Association of American Medical Colleges; Bristol-Myers Squibb; Burroughs Wellcome Fund; Celtic Therapeutics, LLLP; Critical Path Institute; Doris Duke Charitable Foundation; Eli Lilly and Co.; FasterCures; Foundation for the NIH; Friends of Cancer Research; GlaxoSmithKline; Johnson & Johnson; Merck and Co., Inc.; Novartis Pharmaceuticals Corporation; and Pfizer Inc. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

International Standard Book Number-13: 978-0-309-21929-7
International Standard Book Number-10: 0-309-21929-9

Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu.

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

Copyright 2012 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

Suggested citation: IOM (Institute of Medicine). 2012. Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary. Washington, DC: The National Academies Press.

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13237.
×

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

                                                —Goethe

0309219299_0003_002.jpg

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13237.
×

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. 2012. Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13237.
×

PLANNING COMMITTEE FOR THE WORKSHOP SERIES ON IMPROVING THE CLINICAL TRIAL PROCESS IN THE UNITED STATES1

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

BARBARA ALVING,2 National Center for Research Resources, Bethesda, MD

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

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

ROBERT CALIFF, Duke University Medical Center, Durham, NC

SCOTT CAMPBELL, Foundation for the National Institutes of Health, Bethesda, MD

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

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

PAUL R. EISENBERG, Amgen Inc., Thousand Oaks, CA

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

GARRET A. FITZGERALD, University of Pennsylvania School of Medicine, Philadelphia

ANNALISA JENKINS,3 Merck Serono, Geneva

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

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

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

ELLEN SIGAL, Friends of Cancer Research, Washington, DC

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

JANET WOODCOCK, Food and Drug Administration, White Oak, MD

IOM Staff

ANNE B. CLAIBORNE, Forum Director

REBECCA A. ENGLISH, Associate Program Officer

ELIZABETH F. C. TYSON, Research Associate

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

ROBIN GUYSE, Senior Program Assistant

image

1 Institute 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.

2 Barbara Alving was with National Center for Research Resources until September 30, 2011.

3 Annalisa Jenkins was with Bristol-Myers Squibb as of the dates of the workshop.

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13237.
×

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

MARGARET ANDERSON, FasterCures, Washington, DC

HUGH AUCHINCLOSS, National Institute of Allergy and Infectious Diseases, Bethesda, MD

LESLIE Z. BENET, University of California-San Francisco

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

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

ROBERT CALIFF, Duke University Medical Center, Durham, NC

SCOTT CAMPBELL, Foundation for the National Institutes of Health, Bethesda, MD

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

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

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

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

GARRET A. FITZGERALD, University of Pennsylvania School of Medicine, Philadelphia

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

STEPHEN GROFT, National Institutes of Health, Bethesda, MD

LYNN HUDSON, Critical Path Institute, Tuscon, AZ

THOMAS INSEL, National Center for Advancing Translational Sciences, Bethesda, MD

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

MARK B. McCLELLAN, The Brookings Institution, Washington, DC

CAROL MIMURA, University of California-Berkeley

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

image

1 Institute 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. 2012. Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13237.
×

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

ELLIOTT SIGAL, Bristol-Myers Squibb, Princeton, NJ

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

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

 JOANNE WALDSTREICHER, Johnson & Johnson, Raritan, NJ

JANET WOODCOCK, Food and Drug Administration, White Oak, MD

IOM Staff

ANNE B. CLAIBORNE, Forum Director

REBECCA A. ENGLISH, Associate Program Officer

ELIZABETH F. C. TYSON, Research Associate

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

ROBIN GUYSE, Senior Program Assistant

Page viii Cite
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Suggested Citation:"Front Matter." Institute of Medicine. 2012. Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13237.
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Reviewers

This report 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 report as sound as possible and to ensure that the report 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 report:

Joan Finnegan Brooks, Patient Focused Market Research

Elmer Freeman, Center for Community Health Education Research and Service, Inc.

Susan Love, Dr. Susan Love Research Foundation

Betsy Myers, Doris Duke Charitable Foundation

Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the final draft of the report before its release. The review of this report was overseen by Carmen R. Green, University of Michigan Medical School. Appointed by the Institute of Medicine, she was responsible for making certain that

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13237.
×

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 report rests entirely with the authors and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13237.
×
Suggested Citation:"Front Matter." Institute of Medicine. 2012. Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13237.
×

Acronyms

ACC

American College of Cardiology

ACTION

Analgesic Clinical Trials Innovation, Opportunities, and Networks

AHA

American Heart Association

 
CABG

coronary artery bypass graft

CBPR

community-based participatory research

CDER

FDA Center for Drug Evaluation and Research

CDRH

FDA Center for Devices and Radiological Health

CF

cystic fibrosis

CRO

contract research organization

CTSA

Clinical and Translational Science Awards

CTSN

Cardiothoracic Surgical Trials Network

CTTI

Clinical Trials Transformation Initiative

 
EHR

electronic health record

 
FDA

U.S. Food and Drug Administration

FURRThER

Families Undergoing Risk Reduction Through Educational Reinforcement

 
GIST

gastrointestinal stromal tumor

 
HRA

Health Research Alliance

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13237.
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IND

investigational new drug

IOM

Institute of Medicine

IRB

Institutional Review Board

 
LVAD

left ventricular assist device

 
NCATS

National Center for Advancing Translational Sciences

NHLBI

National Heart, Lung, and Blood Institute

NIH

National Institutes of Health

NIMHD

National Institute on Minority Health and Health Disparities

 
PDUFA

Prescription Drug User Fee Act

PMA

premarket approval

 
RAIN

Rheumatoid Arthritis Investigational Network

REMATCH

Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure

 
STICH

Surgical Treatment for Ischemic Heart Failure

 
TEAR

Treatment of Early Aggressive Rheumatoid Arthritis

 
VA

U.S. Department of Veterans Affairs

 
WICER

Washington Heights/Inwood Informatics Infrastructure for Community-Centered Comparative Effectiveness Research

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/13237.
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Clinical trials provide essential information needed to turn basic medical research findings into patient treatments. New treatments must be studied in large numbers of humans to find out whether they are effective and to assess any harm that may arise from treatment. There is growing recognition among many stakeholders that the U.S. clinical trials enterprise is unable to keep pace with the national demand for research results. The IOM, along with the Mount Sinai School of Medicine, held a workshop June 27-28, 2011, to engage stakeholders and experts in a discussion about possible solutions to improve public engagement in clinical trials.

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