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Public Confidence and Involvement in Clinical Research Symposium Summary Clinical Research Roundtable September 2000 Andrea L. Kalfoglou, Program Officer Douglas A. Boenning, Senior Program Officer Mary Woolley, Symposium Coordinator Board on Health Sciences Policy INSTITUTE OF MEDICINE Washington, D.C.
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INSTITUTE OF MEDICINE 2101 Constitution Avenue, N.W. Washington, DC 20418 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 AMA, AAMC, AHRQ, VA, CDC, FDA, NIH, RWJ, Blue Cross/Blue Shield, Johnson & Johnson, Burroughs Wellcome Fund, Merck and Co., Pfizer, Inc., and the Doris Duke Charitable Foundation. The views presented in this report are those of the Institute of Medicine Clinical Research Roundtable and are not necessarily those of the funding agencies. Additional copies of this report are available in limited quantities from the Board on Health Sciences Policy, 2101 Constitution Avenue, N.W., Washington, D.C. 20418. Call (202) 334-2653. The full text of this report is available at www.nap.edu. For more information about the Institute of Medicine , visit the IOM home page at www.iom.edu. Copyright 2001 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.
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“Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE Shaping the Future for Health
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THE NATIONAL ACADEMIES National Academy of Sciences National Academy of Engineering Institute of Medicine National Research Council 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. William 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. Kenneth I. Shine 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. Bruce M. Alberts and Dr. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council.
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Clinical Research Roundtable WILLIAM GERBERDING, (Chair), President Emeritus, University of Washington, Seattle, Washington TOM BEAUCHAMP, Professor of Philosophy and Senior Research Scholar, Kennedy Institute of Ethics, Georgetown University, Washington, D.C. ENRIQUETA BOND, President, Burroughs Wellcome Fund, Research Triangle Park, North Carolina 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, JR., Professor of Medicine, Harvard University, Director of Clinical Research, Massachusetts General Hospital, Boston, Massachusetts ADRIAN DOBS, Associate Professor of Medicine, Director, Clinical Research Unit, Johns Hopkins University School of Medicine, Baltimore, Maryland JOHN FEUSSNER, Chief Research and Development Officer, Department of Veterans’ Affairs, Washington D.C. 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 JACK GREBB, Senior Vice President, Research and Development, Janssen Research Foundation, Titusville, New Jersey Johnson & Johnson, Global CNS/Analgesia Clinical 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 MARY LERCHEN, Director, Prevention Research and Academic Partnerships, Center for Disease Control and Prevention, Atlanta, Georgia 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
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BERNARD SCHWETZ, Acting Deputy Commissioner and Senior Advisor for Science, Food and Drug Administration, Rockville, Maryland LOUIS SHERWOOD, Senior Vice President for Medical and Scientific Affairs, Merck and Co., West Point, Pennsylvania WILLIAM SIGMUND, Vice President for Medical Affairs, Pfizer Pharmaceuticals Group, 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 MYRL WEINBERG, President, National Health Council, Washington D.C. MICHAEL J. WELCH, Co-Director, Division of Radiological Sciences, The Edward Mallincrodt Institute of Radiology, Washington University School of Medicine, St. Louis, Missouri Liaisons to the Roundtable DAVID BLUMENTHAL, Liaison to the Board on Health Sciences Policy; Director, Institute for Health Policy, Massachusetts General Hospital/Partners HealthCare System STEVEN PAUL, Liaison to the Board on Neuroscience and Behavioral Health; Vice President, Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center HUGH TILSON, Liaison to the Board on Health Promotion and Disease Prevention; Senior Advisor to the Dean, School of Public Health, University of North Carolina, Global Health Outcomes, Glaxo Wellcome Company MARY WOOLLEY, Liaison to the Board on Health Sciences Policy; President, Research! America Study Staff ANDREW M. POPE, Director, Board on Health Sciences Policy ALEX OMMAYA, Project Director (May 2001-Current) ANDREA KALFOGLOU, Program Officer DOUGLAS BOENNING, Project Director (June 2000-March 2001) CURT TAYLOR, Senior Project Assistant (July 2000-March 2001) Contributing Staff FREDERICK J. MANNING, Senior Program Officer CHARLES EVANS, Senior Advisor for Biomedical and Clinical Research ALDEN CHANG, Administrative Assistant
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REVIEWERS The report was reviewed 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 to assist the authors and the Institute of Medicine in making the 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 content of the review comments and the draft manuscript remain confidential to protect the integrity of the deliberative process. The committee wishes to thank the following individuals for their participation in the report review process: Bernard A. Schwetz, Acting Deputy Commissioner of Food and Drugs, Food and Drug Administration, Rockville, Maryland Hugh Tilson, Liaison to the Board on Health Promotion and Disease Prevention; Senior Advisor to the Dean, School of Public Health, University of North Carolina, Global Health Outcomes, Glaxo Wellcome Company Mel Worth, M.D., Scholar-in-Residence, Institute of Medicine, Washington, D.C. While the individuals listed above provided many constructive comments and suggestions, responsibility for the final content of the report rests solely with the authoring committee and the Institute of Medicine.