OPPORTUNITIES TO ADDRESS CLINICAL RESEARCH WORKFORCE DIVERSITY NEEDS FOR 2010

Committee on Opportunities to Address Clinical Research Workforce Diversity Needs for 2010

Committee on Women in Science and Engineering

Policy and Global Affairs

Board on Health Sciences Policy

Institute of Medicine

Jong-on Hahm and Alexander Ommaya, Editors

NATIONAL RESEARCH COUNCIL AND INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 OPPORTUNITIES TO ADDRESS CLINICAL RESEARCH WORKFORCE DIVERSITY NEEDS FOR 2010 Committee on Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 Committee on Women in Science and Engineering Policy and Global Affairs Board on Health Sciences Policy Institute of Medicine Jong-on Hahm and Alexander Ommaya, Editors NATIONAL RESEARCH COUNCIL AND INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 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. This project was supported by the National Institutes of Health, Grant No. N01-OD-4-2139, Task Order #142, and the National Academy of Sciences. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project. International Standard Book Number 0-309-09248-5 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. Copyright 2006 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 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. 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. 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. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 COMMITTEE ON OPPORTUNITIES TO ADDRESS CLINICAL RESEARCH WORKFORCE DIVERSITY NEEDS FOR 2010 E. Albert Reece, M.D., Chair, Vice Chancellor and Dean, University of Arkansas College of Medicine Rick Martinez, M.D., Director of Medical Affairs, Johnson and Johnson Nancy E. Reame, Ph.D., Mary Dickey Lindsay Professor of Nursing and Director, DNSc Program, Columbia University Sally Shaywitz, M.D., Co-director, Yale Center for the Study of Learning and Attention, Yale University School of Medicine Nancy Sung, Ph.D., Senior Program Officer, Burroughs Wellcome Fund NRC Staff Jong-on Hahm, Ph.D., Study Director Elizabeth Briggs, Senior Program Associate IOM Staff Alex Ommaya, Sc.D., Senior Program Officer Michelle Lyons, M.S., Research Associate (until December 2004) Amy Haas, Senior Program Assistant

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 COMMITTEE ON WOMEN IN SCIENCE AND ENGINEERING Lilian Wu, Chair, Director of University Relations, International Business Machines Lotte Bailyn, T. Wilson Professor of Management, Sloan School of Management, Massachusetts Institute of Technology Ilene Busch-Vishniac, Professor, Mechanical Engineering, The Johns Hopkins University Ralph J. Cicerone, Former Chancellor, University of California, Irvine (until January 2005) Allan Fisher, President and CEO, iCarnegie, Inc. Sally Shaywitz, Co-director, Yale Center for the Study of Learning and Attention, Yale University School of Medicine Julia Weertman, Professor Emerita, Department of Material Science and Engineering, Northwestern University Staff Jong-on Hahm, Director (until October 14, 2005) Peter Henderson, Acting Director (from October 15, 2005) Charlotte Kuh, Deputy Executive Director, Policy and Global Affairs John Sislin, Program Officer Elizabeth Briggs Huthnance, Senior Program Associate Amaliya Jurta, Senior Program Assistant (through July 2002)

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 BOARD ON HEALTH SCIENCES POLICY Fred H. Gage, Chair, The Salk Institute for Biological Studies, La Jolla, California Gail H. Cassell, Eli Lilly and Company, Indianapolis, Indiana James F. Childress, University of Virginia, Charlottesville Ellen Wright Clayton, Vanderbilt University Medical School, Nashville, Tennessee David R. Cox, Perlegen Sciences, Mountain View, California Lynn R. Goldman, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland Bernard D. Goldstein, University of Pittsburgh, Pittsburgh, Pennsylvania Martha N. Hill, Johns Hopkins University School of Nursing, Baltimore, Maryland Alan Leshner, American Association for the Advancement of Science, Washington, D.C. Daniel Masys, Vanderbilt University Medical Center, Nashville, Tennessee Jonathan D. Moreno, University of Virginia, Charlottesville E. Albert Reece, University of Arkansas, Little Rock Myrl Weinberg, National Health Council, Washington, D.C. Michael J. Welch, Washington University School of Medicine, St. Louis, Missouri Owen N. Witte, University of California, Los Angeles Mary Woolley, Research!America, Alexandria, Virginia IOM Staff Andrew M. Pope, Director Amy Haas, Board Assistant David Codrea, Financial Associate

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 Preface Increasing diversity in the U.S. population has sharpened concerns about the vitality and diversity of the clinical research workforce, concerns that have persisted for two decades. Our nation’s unprecedented level of investment in biomedical research has led to an explosion of new knowledge about human health and disease, but basic research achievements must be translated into treatments and therapies in order to benefit human health. This translation requires clinical research conducted by outstanding scientists, physicians, and other health professionals who understand the complexities and nuances of health and disease among different population groups. Clinical research as an enterprise has traditionally not received the high level of regard afforded basic research in the research and academic communities, which may be contributing to decreased interest in clinical research careers among matriculating medical students. This must change if we are to continue the pace of achievement in translating gains in basic science to treatment of human disease. All biomedical researchers have a stake in ensuring that the clinical research workforce thrives and diversifies for the benefit of human health. 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 Academies’ Report Review Committee. The purpose of this independent review is to provide candid and critical

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 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: Karen Antman, National Cancer Institute for Translational and Clinical Sciences; Elaine Gallin, Doris Duke Charitable Foundation; Page Morahan, Hedwig van Ameringen Executive Leadership in Academic Medicine Program; Jay Moskowitz, Pennsylvania State University; Joel Oppenheim, New York University; Diane Wara, University of California, San Francisco; and Judith Woodruff, Northwest Health Foundation. Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by Elena Nightingale, Institute of Medicine, and Willie Pearson, Georgia Institute of Technology. Appointed by the National Academies, they were 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. E. Albert Reece, M.D. Chair

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 Contents     SUMMARY   1 1   INTRODUCTION   7      Lessons from the Business Sector,   10      Implications for Academic Health Centers,   10      The Focus of This Study,   11 2   THE CLINICAL RESEARCH WORKFORCE: ACROSS-THE-BOARD CHALLENGES   14      NIH Investment in the Clinical Research Workforce,   15      Workforce Challenges for the Private Sector in Clinical Research,   22      The Shortage of Clinical Investigators,   23      Future Needs,   32 3   THE STATUS OF WOMEN AND UNDERREPRESENTED MINORITIES AND PROGRAMS OF SUPPORT   33      Women Faculty,   33      Women Medical School Students,   37      Underrepresented Minority Faculty,   37      Underrepresented Minority Students in Medical Schools,   39      NIH Programs for Clinical Research and Minority Researchers,   42

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010      Department of Veterans Affairs Programs,   47      Private Sources of Funding for Clinical Investigators,   49      Future Directions,   52 4   THE STATUS AND FUTURE ROLE OF ACADEMIC NURSING IN CLINICAL RESEARCH   55      The Advancing Age of Nursing Faculty,   55      Preparing a Diverse and Representative Clinical Research Workforce,   57      National Institute of Nursing Research,   59      Future Needs at the Interface of Nursing and Clinical Research,   61 5   CONCLUSIONS AND RECOMMENDATIONS   66      Recommendations,   68     REFERENCES   75     APPENDIXES         A  Biographies of Speakers   87     B  Workshop Guests   95     C  Workshop Agenda   102     D  Public Mechanisms for Clinical Research Training: Examples of Minority Research Training Programs   107     E  Public Mechanisms for Clinical Research Training   116     F  Examples of Pharmaceutical Company Training Programs   122

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 List of Tables, Figures, and Boxes TABLES 2-1   NIH Clinical Research Awards, FY 1996-FY 2001,   16 2-2   First-time NIH Applicants and Awards, FY 1995-FY 2001,   17 2-3   M.D. and Ph.D. NIH Applications, Awards, and Success Rates, FY 1990-FY 2001,   17 2-4   Targeted NIH Clinical Research Awards (Type 1—K23, K24, and K30), FY 1999-FY 2003,   18 3-1   Distribution of Full-Time U.S. Medical School Faculty by Sex and Rank, 2003,   34 3-2   Hispanic Ethnicity and Non-Hispanic Race Medical School Applicants by Acceptance Status, 2002 and 2003,   40 3-3   Distribution of Loan Repayment Program Applicants by Sex, FY 2003,   46 4-1   Race and Ethnicity of Graduates from Baccalaureate, Master’s, and Doctoral Programs in Nursing, 1999-2002,   58

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 FIGURES 1-1   Percent of the population by race or ethnicity: 1990, 2000, 2025, and 2050,   8 3-1   Black, Native American, and Hispanic U.S. medical school faculty, 1980-2000,   38 3-2   Medical school faculty by race/ethnicity, 2002,   38 3-3   Black, Asian, and Hispanic M.D.–Ph.D. graduates, 1986-2002,   42 3-4   New applications and funded awards for four NIH loan repayment programs, FY 2002 and FY 2003,   45 BOXES 2-1   Recommendations of the 2003 NIH Director’s Blue Ribbon Panel on the Future of Intramural Clinical Research,   20 3-1   Summary,   53 4-1   Summary,   63