The Role of
Purchasers and Payers
in the
Clinical Research Enterprise

WORKSHOP SUMMARY

Sean Tunis, Allan Korn, and Alex Ommaya, Editors

Based on a Workshop of the Clinical Research Roundtable

Board on Health Sciences Policy

INSTITUTE OF MEDICINE

NATIONAL ACADEMY PRESS
Washington, D.C.



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The Role of Purchasers and Payers in the Clinical Research Enterprise WORKSHOP SUMMARY Sean Tunis, Allan Korn, and Alex Ommaya, Editors Based on a Workshop of the Clinical Research Roundtable Board on Health Sciences Policy INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C.

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NATIONAL ACADEMY PRESS 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 Agency for Healthcare 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 Foundation. The views presented in this report are those of the authors and are not necessarily those of the funding agencies. International Standard Book Number 0-309-08349-4 Library of Congress Control Number 2002106553 Additional copies of this report are available for sale from the National Academy Press, 2101 Constitution Avenue, N.W., Box 285, Washington, D.C.20055. Call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area), or visit the NAP’s home page at www.nap.edu. 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 2002 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. 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. 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. Wm. A. Wulf are chairman and vice chairman, respectively, of the National Research Council.

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CLINICAL RESEARCH ROUNDTABLE WILLIAM GERBERDING, (Co-chair), President Emeritus, University of Washington, Seattle, Washington ENRIQUETA BOND, (Co-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. 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, 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, Johnson & Johnson, Global CNS/ Analgesia Clinical Research and Development, Janssen Research Foundation, Titusville, New Jersey LAWRENCE GREEN, Director, Office of Extramural Prevention Research, Centers for Disease Control and Prevention, Atlanta, Georgia 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, Vice Chancellor and Dean, University of Arkansas College of Medicine, Little Rock, Arkansas DAVID L. RIMOIN, Chairman of Pediatrics and Director, Medical Genetics-Birth Defects Center Cedars-Sinai Medical Center, Los Angeles, California

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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 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 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, Coverage and Analysis Group, Office of Clinical Standards and Quality Centers for Medicare and Medicaid Services 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 ANDREA KALFOGLOU, Program Officer VANESSA WALKER, Research Assistant PERRY LUKSIN, Senior Project Assistant

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Division Staff ANDREW POPE, Division Director ALDEN CHANG, Administrative Assistant CARLOS GABRIEL, Financial Associate LAURIE YELLE, Consultant

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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 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 deliberative process. We wish to thank the following individuals for their review of this report: Edward Campion, M.D., New England Journal of Medicine Carolyn Clancy, M.D., Agency for Healthcare Research and Quality (AHRQ) Michael R. McGarvey, M.D., Chief Medical Officer BCBSNJ, Retired Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions nor did they see 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 institutional 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 Enriqueta Bond, Ph.D. Liaison, Institute of Medicine President, Burroughs Wellcome Fund Research Triangle Park, North Carolina The Clinical Research Roundtable was convened by the Institute of Medicine in early 2000. Since then the roundtable has discussed many issues relevant to clinical research and has sponsored several symposia, the proceedings for which are available on its website www.iom.edu/crr. The roundtable brings together 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, corporate purchasers of health care, and representatives of patient interests. Their mission is to discuss the challenges facing the Clinical Research Enterprise and the approaches that might be adapted to create a more supportive and efficient environment for the conduct of a broad agenda of high-quality clinical research to benefit the American public. The roundtable provides a forum and sponsors workshops for discussion of approaches to resolving both acute and long-term issues affecting clinical research. 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. Some issues germane to the development and continued vitality of clinical research include workforce career development in clinical research across the health professions; 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

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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. The Clinical Research Roundtable was created to provide a place where a very complicated set of actors, who are all very important to the Clinical Research Enterprise, could begin to talk to one another and gain a better understanding of each others’ perspectives. The workshop has well launched us on that course. Many significant follow-up activities were exposed during the workshop that will allow us to continue to better identify and describe how to advance the Clinical Research Enterprise in ways that will greatly improve patient health. The ideas presented in this summary are exciting and display a great openness of the payer-purchaser community and a variety of efforts under way to the challenges that arose during the workshop. This workshop focused specifically on what purchasers (employers) and payers (insurance companies) want from the Clinical Research Enterprise, what their role is with respect to the enterprise, and what they can contribute to it. Since its inception the Clinical Research Roundtable has been working to define the dimension and size of the Clinical Research Enterprise. We have identified how large and how fragmented the enterprise is, and we have determined that the advancement of the nation’s health depends critically on all the pieces working together in a much better way than they do now and on our gaining better understanding of each other’s roles. The workshop explored the following questions with the purchasers and payers: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met your needs? What steps are necessary to improve the Clinical Research Enterprise? What are your top priorities for clinical research? Who should fund research studies? What are purchasers and payers willing to contribute to the Clinical Research Enterprise? Can you point to effective partnerships that have produced worthwhile results from the purchaser and payer perspectives? What are the most effective methods for addressing questions of interest for purchasers and payers? The agenda of the workshop, as reflected in the summaries of the workshop presentations contained in this report, was organized to elicit the responses to these questions first from the perspective of purchasers (employers), then from the perspective of payers (health plans and insurance companies), and finally from the perspective of stakeholders (voluntary health associations and researchers). In the final session of the workshop, opportunities and challenges in the Clinical Research Enterprise were discussed from the perspective of all participants in the enterprise, including consumers. Although speakers expressed many diverse points of view during the workshop, all recognized the opportunity for health care purchasers, payers, researchers, and other stakeholders to work collaboratively, as part of the Clinical Research Enterprise, to meet the many challenges in this country’s health care.

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Contents     FOREWORD   ix     WORKSHOP SUMMARY   1     INTRODUCTION TO THE WORKSHOP   5 1   THE ROLE OF PURCHASERS IN THE CLINICAL RESEARCH ENTERPRISE   9     Introduction,   9     What Purchasers Need from the Clinical Research Enterprise,   9     Pharmaceutical Costs and Value for Purchasers,   14     Translational Blocks,   16     Challenges for Purchasers in the Clinical Research Enterprise,   18     Proposal for a National Clinical Research Enterprise Coordinating Activity,   21     The Importance of Prevention Research,   22     Consumer Involvement,   24     Publication of a Research Priorities Proposal,   25     Summary,   26

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2   THE ROLE OF PAYERS IN THE CLINICAL RESEARCH ENTERPRISE   29     Introduction,   29     What Payers Need from the Clinical Research Enterprise,   30     What Payers Are Willing to Contribute to the Clinical Research Enterprise,   37     Research Priorities and Priority Setting for Payers,   40     Translational Blocks,   43     Consumer Demand,   47     Patient Participation in Clinical Research,   48     Summary,   48 3   THE ROLE OF OTHER STAKEHOLDERS IN THE CLINICAL RESEARCH ENTERPRISE   51     Introduction,   51     The Role of Voluntary Health Associations in the Clinical Research Enterprise,   52     Priority Setting in Basic and Clinical Research,   56     Priority Setting in Health Services Research,   58     Health Services Research in Voluntary Health Associations,   61     The Role of the Device Industry in the Clinical Research Enterprise,   63     The Role of the Agency for Healthcare Research and Quality in the Clinical Research Enterprise,   65     Translational Blocks and Practice Guidelines,   66     Summary,   68 4   OPPORTUNITIES AND CHALLENGES IN THE CLINICAL RESEARCH ENTERPRISE   70     Introduction,   70     Outcomes Research and Disease Management,   71     Integrated Patient-Centered Care,   75     Research Priorities in Pharmaceutical Companies,   75     Summary,   80     SUGGESTED READINGS   82 APPENDIX I:   Speaker Biographies   83 APPENDIX II   Speaker’s Company Profiles   90 APPENDIX III:   Purchaser Payer Background Information   94

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APPENDIX IV:   Workshop Agenda   97 APPENDIX V:   Definitions of Clinical Research and Components of the Enterprise   101     Definition of Clinical Research,   101     Major Components of the Clinical Research Enterprise,   101 APPENDIX VI:   Registered Workshop Participants   103

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