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Exploring Challenges, Progress, and New Models for NGAGING THE PUI in the LINICAL YES EAR. NTERPRISE ILl. OH C/inica/ Research Boundiab/e Workshop Summary Basecl on a Workshop of the Clinical Research Rouncltable Boa rcl on Health Sciences Policy Jessica Aungst, Amy Hans, Alexander Ommaya, Lawrence W. Green, Editors INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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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. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. Support for this project was provided by the Agency for Health Care Research and Quality, American Medical Association, Association of American Medical Colleges, BlueCross/ BlueShield Association, Burroughs Wellcome Fund, Centers for Disease Control and Prevention, Centers for Medicare and Medicaid Services (formerly HCFA), Department of Veterans Affairs, Doris Duke Charitable Foundation, Food and Drug Administration, Johnson & Johnson, Merck and Company, National Institutes of Health, Pfizer Inc., and the Robert Wood Johnson Founda- tion. The views presented in this report are those of the authors and are not necessarily those of the funding agencies. International Standard Book Number 0-309-08946-8 (book) International Standard Book Number 0-309-51726-5 (PDF) Library of Congress Control Number: 2003107016 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 Washing- ton 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 2003 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 Insti- tute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

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"I(nowin,g is not enough; we mast apply. Willing is not enough; we must dlo. " Goethe . ........................ .... ............. ...... . .. .. . .:: INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES Shaping the Future for Health

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THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Meditine 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. Bruce M. Alberts 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. Wm. A. Wulf 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. Func- tioning 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. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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CLINICAL RESEARCH ROUNDTABLE Enriqueta Bond, (Chair) President, Burroughs Wellcome Fund, Research Triangle Park, North Carolina Tom Beauchamp, Professor of Philosophy and Senior Research Scholar, Kennedy Institute of Ethics, Georgetown University, Washington, D.C. James Burris, Acting Chief Research and Development Officer, Department of Veterans' Affairs, Washington, D.C. Veronica Catanese, Associate Dean, New York University School of Medicine, Director of Development, American Federation for Medical Research Foundation, New York, New York Francis Chesley, Director, Office of Research, Review, Education and Policy, Agency for Healthcare Research and Quality, Rockville, Maryland William F. Crowley, ,Ir., Professor of Medicine, Harvard University, Director of Clinical Research, Massachusetts General Hospital, Boston, Massachusetts Adrian Dobs, Professor of Medicine, Director, Clinical Research Unit, Johns Hopkins University School of Medicine, Baltimore, Maryland John Feussner, Professor and Chairman, Department of Medicine, Medical University of South Carolina, Charleston, South Carolina Myron Genel, Associate Dean, Office of Government and Community Affairs, Yale University School of Medicine, New Haven, Connecticut Kenneth Getz, President/Publisher, CenterWatch, Boston, Massachusetts Christine Grady, Section Head, Human Subjects Research, National Institutes of Health, Rockville, Maryland Jack Grebb, Senior Vice President, Johnson & Johnson, Global CNS/Analgesia Clinical Research and Development, Janssen Research Foundation, Titusville, New Jersey Lawrence W. Green, Director, Office of Science and Extramural Research, Center for Disease Control and Prevention, Atlanta, Georgia Stephen B. Johnson, Associate Professor, Columbia University, New York, New York Stephen Katz, Director, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Chief, Dermatology Branch, National Cancer Institute, Bethesda, Maryland Allan M. Korn, Senior Vice President, Chief Medical Officer, Blue Cross/Blue Shield Association, Chicago, Illinois David Korn, Senior Vice President for Biomedical and Health Sciences Research, Association of American Medical Colleges, Washington, D.C. Elaine L. Larson, Professor of Pharmaceutical and Therapeutic Research, Columbia University School of Nursing, New York, New York E. Albert Reece, Abraham Roth Professor and Chairman, Department of Obstetrics, Gynecology, and Reproductive Sciences, Temple University School of Medicine, Philadelphia, Pennsylvania David L. Rimoin, Chairman of Pediatrics and Director, Medical Genetics-Birth Defects Center Cedars-Sinai Medical Center, Los Angeles, California Patricia Salber, Medical Director for Managed Care Health Care Initiative, General Motors Co., The Permanente Company, Larkspur, California Lewis Sandy, Executive Vice President, Robert Woods Johnson Foundation, Princeton, New Jersey David Scheinberg, Doris Duke Clinical Science Professor Chief, Leukemia Service, Memorial Sloan- Kettering Cancer, New York, New York v

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Bernard Schwetz, Acting Deputy Commissioner and Senior Adv Administration, Rockville, Maryland Louis Sherwood, Senior Vice President for Medical and Scientific Affairs, Merck and Co., West Point, Pennsylvania William Sigmund, Senior Vice President, Pfizer, Inc., New York, New York Lana Skirboll, Director, Office of Science Policy, National Institutes of Health, Rockville, Maryland Harold Slavkin, Dean, G. Donald and Marian James Montgomery Professor of Dentistry, School of Dentistry, University of Southern California, Los Angeles, California Sean Tunis, Director of Coverage and Analysis Group, Centers for Medicare and Medicaid Services, Baltimore, Maryland Myrl Weinberg, President, National Health Council, Washington D.C. Michael ,l. Welch, Co-Director, Division of Radiological Sciences, The Edward MallincroUt Institute of Radiology, Washington University School of Medicine, St. Louis, Missouri isor for Science, Food and Drug Liaisons to the Clinical Research Roundtable Steven Paul, Group Vice President, Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center Hugh Tilson, Senior Advisor to the Dean, School of Public Health, University of North Carolina Mary Woolley, President, Research!America Study Stay Alex Ommaya, Study Director Jessica Aungst, Research Assistant Amy Haas, Senior Project Assistant Division Stay Andrew Pope, Division Director Troy Prince, Administrative Assistant Carlos Gabriel, Financial Associate vim

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Revi ewers 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 NRC' 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 institu- tional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: Dolph Chianchiano, Ph.D., National Kidney Foundation, Inc. Patricia Hinton, American Heart Association Susan L. Weiner, Ph.D., The Children's Cause, Inc. 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 Mel Worth, Scholar-in-Residence, Institute of Medicine, who was responsible for making certain that an independent examination of this report was carried out in accordance with insti- tutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution. . . via

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Foreword The Institute of Medicine convened the Clinical Research Roundtable (CRR) in early 2000 to pro- vide a forum for stakeholders to discuss approaches to resolving both acute and long-term issues affect- ing the Clinical Research Enterprise. It strives to enhance mutual understanding of clinical research between the scientific community and the general public, while improving the public's understanding of and participation in clinical studies. The stakeholders involved in the CRR include individuals from the academic health community, federal agencies sponsoring and regulating clinical research, private-sector sponsors of clinical research, foundations, public- and private-sector insurance programs, health plans and insurance companies, cor- porate purchasers of health care, and representatives of patient interests. Since its inception, the Roundtable has discussed many issues relevant to clinical research and has sponsored several symposia, the proceedings of which are available on its website, www.iom.edu/crr. The issues addressed by the CRR include workforce career development in clinical research across the health profession; the linkage between discoveries in basic science and their application to improved patient care; the essential coordination of clinical research within and between research entities and disciplines; the ability of academic health centers to conduct clinical research and training; the broad participation of health professionals in clinical research across all practice settings and emerging health care systems; the timely incorporation into clinical practice of new research findings and findings on health outcomes; and the availability of financial and other data to monitor and assess the different components of patient- and population-based health research. During the dialogue between the various stakeholders that has been facilitated by the CRR, the Roundtable members realized that the Clinical Research Enterprise is not an entity; it is a very complex enterprise made up of many stakeholders the doctors, the patients, the public, the academic health centers, the industry entities who do not necessarily function in a seamless fashion. The CRR has identified four major challenges to the Clinical Research Enterprise: enhancing public participation in clinical research, which includes making the system safer and faster; developing the neces- sary information systems that are needed to make the clinical research enterprise a coordinated and seam- less whole; fostering an adequately trained workforce; and ensuring adequate funding for clinical research. In addition, the CRR has identified two translational blocks from basic science into clinical prac- tice and from the clinical identification of things that work into broader application to improve medical care and the public's health. This workshop summary addresses the contribution of the public to over- coming these obstacles. Six

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Contents Foreword Workshop Summary 1 Priorities for Engaging the Public in the Clinical Research Enterprise Workshop Introduction, 5 Priorities for Engaging the Public, 6 Key Issues Facing the Clinical Research Enterprise, 7 2 What Is Participant-Centered Clinical Research? Introduction, 9 Defining Participatory Research, 9 Factors to Facilitate the Use of Participatory Research by Researchers, 12 Participant Involvement, 13 Encouraging Participant Enrollment and Physician Awareness, 14 Challenges to Community Involvement, 15 Relevance of Community Studies, 15 Model Participatory Research Collaborations, 16 Effectiveness of Public Involvement, 20 Advocacy and Public Involvement, 20 Role of Industry, 21 Summary, 21 3 Increasing the Role of the Public in Research Oversight Introduction, 24 Responsible Research: A Systems Approach to Protecting Research Participants, 24 Issues Regarding Independent Members of IRBs, 27 Public Involvement in the Accreditation Process, 29 New Models of Ethical Review, 30 Guidance on Interpretation of the Regulations, 33 x~ 1X 1 5 9 24

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. . xt! Evidence of Misconduct in Clinical Research, 33 Summary, 34 4 Steps to Improve the Translation and Dissemination of the Results of Clinical Research Introduction, 36 The Internet and Health Communication, 37 The Role of Voluntary Health Associations, 38 Translation and Dissemination of the Results of Clinical Research at the National Institutes of Health, 40 Engaging Providers in Health Information Dissemination, 41 Targeting Messages, 42 Funding for Research Translation, 42 Negative Clinical Research Results, 42 Summary, 43 Appendixes A Workshop Agenda B Speaker Biographies C Background for CRR Workshop: Exploring New Models for Engaging the Public in the Clinical Research Enterprise D Voluntary Health Agencies and the Clinical Research Enterprise: Exploratory Focus Groups E Registered Workshop Participants CONTENTS 36 47 50 54 57 78

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List of Tables, Figures, and Boxes TABLES D.1 Website Survey of Selected Voluntary Health Agencies, 65 FIGURES 2.1 2.2 3.1 3.2 3.3 3.4 3.5 3.6 4.1 4.2 4.3 2.2 2.3 2.4 2.5 3.1 3.2 4.2 4.3 The Translational Blocks, 10 The CDMRP Cycle, 17 Distribution of Site Visit Noncompliance Findings, OHRP Compliance Data 10/98-12/2001, 25 Formal Complaints to FDA Regarding IRE Deficiencies, 25 Distributed Network Consortium, 31 Centralized Consortium, 31 Tandem Model, 32 Practice-Based Research Network Model, 32 Sources of Health Information, 38 Community Centered Research Infrastructure, 39 Community Centered Research Coordination, 40 BOXES 1.1 Summary, 8 2.1 Guidelines for Classifying Participatory Research Projects in Health Promotion, 11 Responsibilities of CDMRP Participants, 17 CDMRP Outreach to Consumers 18 Lessons Learned Through the Genentech Partnership for Herceptin, 19 Summary, 21 Guidelines for Independent Members of Research ERBs, 28 Summary IOM Report, 34 4.1 Methods to Aid the Implementation of Research Findings in Practice, 37 The Translation and Dissemination of Research Results at NIAMS, 41 Summary, 43 . . . x~

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