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 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 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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