Exploring Challenges, Progress, and New Models for Engaging the Public in the Clinical Research Enterprise: Clinical Research Roundtable Workshop Summary

98 Pages·2003·3.2 MB·English

by  Based on a Workshop of the Clinical Research Roundtable

Exploring Challenges, Progress, and New Models for
ENGAGING THE PUBLIC
in the
CLINICAL RESEARCH
ENTERPRISE
Clinical Research Roundtable Workshop Summary
Based on a Workshop of the Clinical Research Roundtable
Board on Health Sciences Policy
Jessica Aungst, Amy Haas, Alexander Ommaya, Lawrence W. Green, Editors
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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, Jr., 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
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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, 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 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 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 Staff
Alex Ommaya, Study Director
Jessica Aungst, Research Assistant
Amy Haas, Senior Project Assistant
Division Staff
Andrew Pope, Division Director
Troy Prince, Administrative Assistant
Carlos Gabriel, Financial Associate
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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 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.
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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.
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