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Careers in Clinical Research: Obstacles and Opportunities
CAREERS in CLINICAL RESEARCH
Obstacles and Opportunities
Committee on Addressing Career Paths for Clinical Research
Division of Health Sciences Policy
INSTITUTE OF MEDICINE
William N. Kelley and Mark A. Randolph, Editors
NATIONAL ACADEMY PRESS
Washington, D.C.
1994
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Careers in Clinical Research: Obstacles and Opportunities
National Academy Press
2101 Constitution Avenue, NW 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 competencies and with regard for appropriate balance.
This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.
The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine.
This study was supported by the National Institutes of Health, the former Alcohol, Drug Abuse and Mental Health Administration, the Agency for Health Care Policy and Research, the Department of Veterans Affairs, the American Cancer Society, the American Heart Association, Pfizer, Inc., and the Drug Information Association. Additional support for this project was provided by independent Institute of Medicine funds and the National Research Council Fund, a pool of private, discretionary, nonfederal funds that is used to support a program of Academy-initiated studies of national issues in which science and technology figure significantly.
Library of Congress Cataloging-in-Publication Data
Careers in clinical research: obstacles and opportunities/Committee on Addressing Career Paths for Clinical Research, Division of Health Sciences Policy, Institute of Medicine: William N. Kelley and Mark A. Randolph, editors
p. cm.
Includes bibliographical references and index.
ISBN 0–309–04890–7
1. Medicine—Research—Government policy—United States. 2. Medicine—Research—Study and teaching—Government policy—United States. I. Kelley, William N., 1939– II. Randolph, Mark A. III. Institute of Medicine (U.S.). Committee on Addressing Career Paths for Clinical Research.
[DNLM: 1. Career Choice. 2. Research. W 21 C271 1994]
R854.U5C34 1994
610'.72073—dc20
DNLM/DLC
for Library of Congress 94–13014
CIP
Additional copies of this book are available 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).
Copyright 1994 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 image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staatlichemuseen in Berlin.
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Careers in Clinical Research: Obstacles and Opportunities
COMMITTEE ON ADDRESSING CAREER PATHS FOR CLINICAL RESEARCH
WILLIAM N. KELLEY, Chair, Dean,
School of Medicine, and
Chief Executive Officer,
Pennsylvania Medical Center, University of Pennsylvania, Philadelphia, Pennsylvania
KAREN H. ANTMAN, Professor of Medicine and Chief,
Division of Medical Oncology, College of Physicians and
Surgeons of Columbia University,
Columbia Presbyterian Medical Center, New York, New York
DOROTHY BROOTEN, Professor and Chair,
Health Care of Women and Childbearing,
Director,
Low Birthweight Research Center, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania
MARY E. CHARLSON, Associate Professor of Medicine,
Cornell University School of Medicine, New York Hospital, New York, New York
ROBERT C. COLLINS, Professor and Chairman,
Department of Neurology, School of Medicine, University of California at Los Angeles, Los Angeles, California
HAILE T. DEBAS, Professor and Chairman,
Department of Surgery, University of California at San Francisco, School of Medicine, San Francisco, California
WILLIAM LEO DEWEY, Professor of Pharmacology, Associate Provost for Research and Graduate Affairs, Dean of the Graduate School,
Virginia Commonwealth University, Richmond, Virginia
JANICE G. DOUGLAS, Professor of Medicine,
School of Medicine, Case Western Reserve University, Cleveland, Ohio
IRVING H. FOX, Vice President for Medical Affairs,
Biogen, Inc., Cambridge, Massachusetts
ROBERT J. GENCO, Associate Dean for Graduate Studies, Distinguished Professor and Chairman,
Department of Oral Biology, School of Dental Medicine, State University of New York at Buffalo, Buffalo, New York
DAVID J. KUPFER, Professor and Chairman of Psychiatry,
School of Medicine, University of Pittsburgh,
Director of Research,
Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania
NICHOLAS F. LARUSSO, Professor and Chairman,
Division of Gastroenterology,
Director,
Center for Basic Research in Digestive Diseases, Mayo Clinic and Research Foundation, Rochester, Minnesota
ALBERT G. MULLEY, JR.,
Harvard Medical School, General Internal Medicine Unit, Massachusetts General Hospital, Boston, Massachusetts
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Careers in Clinical Research: Obstacles and Opportunities
JOHN D. STOBO, William Osler Professor of Medicine, Director and Physician-in-Chief,
Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland
MYRON L. WEISFELDT, Samuel Bard Professor of Medicine, Chair,
Department of Medicine, College of Physicians and
Surgeons of Columbia University,
Columbia Presbyterian Medical Center, New York, New York
CATHERINE M. WILFERT, Professor of Pediatrics and Microbiology,
Duke University Medical Center, Durham, North Carolina
Study Staff
Mark A. Randolph, Study Director
Joseph Cassells, Special Assistant
Ruth Ellen Bulger, Director,
Division of Health Sciences Policy (until August 1993)
Valerie P. Setlow, Director,
Division of Health Sciences Policy (from August 1993)
Sarah Zielinski Quinn, Project Assistant
Mary Jane Ball, Project Assistant
Philomina Mammen, Division Assistant
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Careers in Clinical Research: Obstacles and Opportunities
Preface
Concerns about the numbers of individuals pursuing careers in clinical investigation led the Board of Health Sciences Policy of the Institute of Medicine (IOM) to propose a study to review issues surrounding the career pathways of clinical investigators. For this review the President of the National Academy of Sciences and the Chair of the National Research Council appointed a 16-member committee, the Committee on Addressing Career Paths for Clinical Research, in 1991. The committee was composed of academic and industrial clinical investigators and administrators with expertise in nursing, dentistry, evaluative clinical sciences, surgery, epidemiology, and various medical subspecialties.
The committee was charged with identifying and evaluating issues in the education and training pathways for individuals pursuing careers in clinical investigation. In particular, the committee was asked to investigate ways to improve the quality of training for clinical investigators and to delineate pathways for individuals pursuing careers in clinical investigation in nursing, dentistry, medicine, and other related health professions engaging in human research. The committee was charged with addressing the following:
define clinical research,
how to stimulate individuals to pursue careers in clinical investigation,
how to define appropriate curricula for training,
how to identify mechanisms to bridge the gap between the basic and clinical sciences,
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Careers in Clinical Research: Obstacles and Opportunities
how to address funding mechanisms for clinical investigation,
how to establish measures of success in clinical research in addition to obtaining R01 grant support,
how to encourage academic and industrial institutions to protect and reward these valuable investigators, and
how to ensure adequate support mechanisms for retaining clinical researchers.
The study focused on how existing structures and mechanisms in government, academia, and industry might be used in new and innovative ways to foster careers for these groups of researchers. To the extent possible the committee searched for data to inform the committee in making its recommendations. Eleven background papers were commissioned; task forces were established to examine clinical research in nursing and clinical psychology, dentistry and surgery; a workshop was held to analyze training and research funding data and to reveal innovative approaches to training and support of clinical investigators; and a special effort was mounted to screen individual grant awards at NIH in an effort to quantitate the amount of patient-oriented clinical research supported.
Unfortunately, the data the committee was able to find on patient-oriented clinical investigation were not extensive, and those data that were available were not very reliable. Although the committee was unable to find incontrovertible evidence to support some of the committee's claims, the committee is convinced they are valid. Thus, many of the recommendations found in this report represent only the best judgments of this committee. Furthermore, when the committee began its deliberations more than two years ago, serious discussions about health care reform were only beginning to surface. After the inauguration of President Clinton and the initiation of his administration's analysis of the problem and presentation of a plan to reform health care, the committee found itself grappling with the issues regarding the impact that any new (yet, undefined) program might have on the clinical research and training environment. Because of the many intersections of patient care with clinical research, the committee feels that discussions about health care reform must not neglect the crucial role that clinical investigation has played in improving patient care in the past and the opportunities that clinical investigation has to continue to improve human health.
For example, from the health care reform discussions have come the proposal that 55 percent of all trainees in postgraduate medicine be committed to careers in primary care, whereas 45 percent be committed to careers in medical subspecialties. This proposal does not take into account the subset of individuals who are training for careers in academic medicine, where they will contribute to the development and transfer of new technology rather than to the continued expansion of individuals fully committed to the practice of a
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Careers in Clinical Research: Obstacles and Opportunities
subspecialty. One possible solution would be to develop a separate track, the "academic track," as contrasted to the "clinical track." This academic track would be separate from the 55/45 percent split and would not have limits on it with regard to the distribution between primary care and medical specialty disciplines. It would, however, be a small portion (e.g. perhaps 10 percent) of all training positions. If the committee's recommendations are implemented, the committee believes that many barriers will be lowered or removed to recruit, retain, and support clinical investigators who the committee feels are necessary for realizing the promise of science for improved patient care.
William N. Kelley, M.D.
Chair
Committee on Addressing Career Paths for Clinical Research
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Careers in Clinical Research: Obstacles and Opportunities
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Careers in Clinical Research: Obstacles and Opportunities
Contents
EXECUTIVE SUMMARY
1
1
INTRODUCTION
23
Scope of Clinical Research
24
Origins of the Study
29
Charge to the Committee
31
Defining Clinical Research
32
Limits on the Scope of the Study
36
Conduct of the Study
36
Structure of the Report
40
2
NURTURING CLINICAL RESEARCHERS
41
Environment for Clinical Research
43
Clinical Research Workforce
44
Research Involvement of Faculty
50
Academic Recognition
50
Faculty Tracks
55
Competing Time Demands
57
Clinical Research Training
57
Mentoring
58
Lifestyle Issues
60
Conclusions
60
3
CLINICAL RESEARCH FUNDING AND INFRASTRUCTURE
63
The Big Picture
64
Federal Support for Health Sciences R&D
67
Nonprofit Organizations
106
Industry
109
Clinical Research and Third-Party Payers
112
Models of Cooperation
119
Conclusions
121
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Careers in Clinical Research: Obstacles and Opportunities
4
TRAINING PATHWAYS
123
Demographics
127
Kindergarten to College
127
Research Experiences for Undergraduate Students
133
Health Professional Schools
142
Undergraduate Medical Education
145
Graduate Medical Education
161
Barriers to Clinical Research Training
168
Avenues for Postdoctoral Research Training
171
Assessing the Outcomes of Training Programs
178
Model Programs for Research Training
190
Conclusions
194
5
ACADEMIC-INDUSTRY RELATIONSHIPS
197
Objectives of Academic-Industry Relationships
200
Two Cultures
201
Types of Academic-Industry Linkages
202
Programs to Help Commercialize Faculty Research
205
Prevalence of Academic-Industry Relationships
206
Benefits for Industry
207
Benefits for Academic Institutions, Faculty, and Students
209
Risks, Concerns and Conflicts
210
Managing Academic-Industry Relationships
215
Summary and Conclusions
216
REFERENCES
219
APPENDIXES
A
Report of the Task Force on Clinical Research in Dentistry
237
B
Report of the Task Force on Clinical Research in Nursing and Clinical Psychology
251
C
Report of the Task Force on Clinical Research in Surgery
279
D
Agenda for the Workshop on Clinical Research and Training: Spotlight on Funding
301
E
Contributors
305
F
Biographies of Committee Members
309
GLOSSARY
319
INDEX
323
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Careers in Clinical Research: Obstacles and Opportunities
CAREERS in CLINICAL RESEARCH
Obstacles and Opportunities
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Careers in Clinical Research: Obstacles and Opportunities
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