Index

A

Academic health centers

career path of researchers in, 5, 13-14

clinical care component in, 21, 28, 53

in clinical research oversight, 6

cost of graduate medical education, 21, 28

definition, 13

disincentives for clinical research in, 53-55

faculty demographics, 45-50

faculty growth in, 43-44

faculty tracks in, 55-57

funding for research in, 20-21

growth of, 28

in health care plan benefit design, 21

health care reform and, 5, 8

health research spending by, 63

historical development, 43-44

number of, 43, 44

patient access, 21

recognition for researchers in, 13-14, 28-29, 50-55, 60

recommendations, 13-16, 20-21

research infrastructure, 14-15, 60-61

research involvement of faculty, 50

role of, 2, 21

technology assessment in, 21

See also Medical school(s)

Academic-industry linkages, 110

benefits for academic institutions, 209

commercialization of research findings, 205-206

concerns about, 210, 216, 217

conflict of commitment in, 214-215

conflict of interest in, 20, 213-214

current context, 199-200, 216-217

exclusivity of research findings, 212-213

history of, 197-199

industry benefits, 207-209

management of, 215

objections to, 200

objectives of, 20, 200

prevalence, 206-207

proprietary rights issues in, 210-212

recommendations, 20

research culture in, 201-202

research goals and, 211

types of, 202-205

Accreditation/certification

agencies, 16

in clinical psychology, 277-278



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Careers in Clinical Research: Obstacles and Opportunities Index A Academic health centers career path of researchers in, 5, 13-14 clinical care component in, 21, 28, 53 in clinical research oversight, 6 cost of graduate medical education, 21, 28 definition, 13 disincentives for clinical research in, 53-55 faculty demographics, 45-50 faculty growth in, 43-44 faculty tracks in, 55-57 funding for research in, 20-21 growth of, 28 in health care plan benefit design, 21 health care reform and, 5, 8 health research spending by, 63 historical development, 43-44 number of, 43, 44 patient access, 21 recognition for researchers in, 13-14, 28-29, 50-55, 60 recommendations, 13-16, 20-21 research infrastructure, 14-15, 60-61 research involvement of faculty, 50 role of, 2, 21 technology assessment in, 21 See also Medical school(s) Academic-industry linkages, 110 benefits for academic institutions, 209 commercialization of research findings, 205-206 concerns about, 210, 216, 217 conflict of commitment in, 214-215 conflict of interest in, 20, 213-214 current context, 199-200, 216-217 exclusivity of research findings, 212-213 history of, 197-199 industry benefits, 207-209 management of, 215 objections to, 200 objectives of, 20, 200 prevalence, 206-207 proprietary rights issues in, 210-212 recommendations, 20 research culture in, 201-202 research goals and, 211 types of, 202-205 Accreditation/certification agencies, 16 in clinical psychology, 277-278

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Careers in Clinical Research: Obstacles and Opportunities as disincentive to research, 18, 57, 166-167 of medical schools, 167 problems in, 4 recommendations, 16-18 residency review committees, 17, 164-165 specialty board certification, 18, 166-167 Accreditation Committee for Graduate Medical Education, 16, 17 Agency for Health Care Policy and Research, 27 budget, 101, 188 outcomes research, 100-101 role of, 99 AIDS, 67, 97, 99 AIDS Research Debt Relief Program, 12, 190 Alcohol, Drug Abuse and Mental Health Administration (ADAMHA), 64, 69, 73-76, 136 Alliance for Aging Research, 19, 119 American Academy of Orthopaedic Surgeons, 284-285, 300 American Association for the Advancement of Science, 137 American Association of Physicians, 56 American Board of Internal Medicine, 166 American Board of Medical Specialties, 16, 18, 166 American Cancer Society, 107, 189 American College of Surgeons, 294-295 American Federation of Clinical Research, 56 American Heart Association, 107, 189 American Lung Association, 107 American Society for Clinical Investigation, 24, 56 Anesthesiology, 166 Armed Services Health Professional Scholarship, 157-159 Association of American Medical Colleges, 147, 214 Atherogenesis, 26 Autologous bone marrow transplantation, 114 B Basic science research clinical research and, 27, 28-29, 35, 55-57 disease-related, 34 in medical schools, 28-29, 55-57 medical student interest in, 147 NIH grants, 93-94 surgical research, 284, 294 Biomedical and Behavioral Research Scientists: Their Training and Supply, 30 Biomedical Research and Development Price Index, 76 Biotechnology research, 110-111, 199 Breast cancer, 26 autologous bone marrow transplantation for, 114 C California Institute of Technology, 133 Carnegie Mellon University, 133 Centers for Disease Control and Prevention, 12, 67 research spending, 98-99 research training in, 187-188 role of, 98 Clinical Associate Physician program, 12, 186 Clinical research background papers for evaluation of, 38 classification of activities in, 7, 32-34, 88 contribution of, 1, 24, 41-42 cost of, 79 data collection/analysis for evaluation of, 7, 29, 44 definition, 3, 30-31, 32, 34-35, 87-88, 92-93 evaluation strategy, 29-31, 36-40 future challenges to, 4-6, 41-42 future needs in, 3-4, 6, 25-27, 35, 41, 216-217 historical development, 24-29

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Careers in Clinical Research: Obstacles and Opportunities institutional obstacles to, 5 oversight, 5, 6, 7, 18-20 researcher demographics, 44-50 role of, 27, 193-194 scope of, 24-29, 34, 36 supply of researchers, 2, 4, 6, 27, 29 See also Human research; Training for research Clinical Scholars Program, 190 Clinical trials, 5 consortia for conduct of, 204 historical development, 25 third-party payers and, 115-116 Compensation for researchers, 12 in academic-industry collaboration, 203, 204, 213 in academic settings, 13-14 as career path disincentive, 59-60 in clinical psychology, 272-273 in Department of Veterans Affairs, 103 educational debt burden and, 160, 190 Conflict of interest issues, 20, 213-214 Consulting, 203 Cost of training in academic health centers, 21-22 as disincentive to research career, 4, 42, 60, 156, 159-160 recommendations, 12-13 tuition debt relief program, 12-13, 189 See also Funding/funding issues Cystic fibrosis, 26 D Dentistry, 3, 142 clinical research in, 239-251 curriculum, 124 human research training, 11 recommendations, 240, 243-244, 245-247, 249-250 schools, 248-250 Department of Agriculture, 12, 67 Department of Defense, 12, 67, 105, 131, 286-287, 296 Department of Education, 12, 67, 105 Department of Energy, 12, 67 Department of Health and Human Services, 12, 73 health research spending, 67 Department of Veterans Affairs, 12, 67, 282 budget, 102, 103-104 organizational structure, 101 research activities, 101-103 research training in, 188 Dermatology, 166 Disabilities, students with, 137 Disincentives for research career, 42-43 career compensation as, 12, 59-60 clinical care responsibilities as, 170 in clinical psychology, 272-278 duration of training as, 4, 12, 42, 55, 150, 162 educational costs as, 4, 12, 42, 60, 156, 159-160, 190 evaluation of, 29-31 lack of exposure to research practice as, 167-168 lack of role models or mentors as, 4, 29, 58-59 lifestyle factors, 29, 42, 59-60 in medical education, 53-55, 144-145, 167-170 for newly independent investigators, 8, 53 professional status of research as, 4, 12, 28-29, 42, 55, 194 recertification requirements, 18, 57, 166-167 timing of training and, 169 Doctor-patient relationship, 113, 203 Duke University, 151 E Ethics, 155, 192, 203 F F32 awards, 170, 171, 173-175, 178 Federal Coordinating Council on Science, Engineering and Technology , 128, 130, 131

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Careers in Clinical Research: Obstacles and Opportunities Federal government in clinical research oversight, 6, 18-19 commercial use of research funded by, 212-213 departmental support for human research, 12, 67, 101-105 in development of academic medical centers, 44 health research support, 9-10, 63, 65, 67, 120, 197, 198-199, 202 in improvement of research training, 194-195 legislative encouragement of research, 198-199 medical school scholarships, 158 postdoctoral training funded by, 170 in precollege science preparation, 131 training program outcomes, 188-189 undergraduate science programs, 134-136 See also specific agency or department First Investigator Research Support and Transition, 8 Food and Drug Administration, 115, 188, 200 Foundations, 106-107, 189, 190 Four Schools Physician-Scientist Program in Internal Medicine, 151 Funding/funding issues academic health centers, 20-21 academic-industry collaborations, 203, 204, 205 average cost of research grant, 102 basic research, clinical research vs., 28-29 in Centers for Disease Control and Prevention, 98-99 central management of, 19 clinical psychology, 270-271 comparative cost of human research, 79 in cooperative model of research management, 118-121 cost of medical education, 156-160 data for evaluation of, 5, 64 Department of Defense research spending, 105 Department of Education research spending, 105 in Department of Veterans Affairs, 102, 103-104 faculty, support for, 193-194 in General Clinical Research Centers, 97 government support, 9-10, 64-67, 197, 198-199 grant size, 76 grant writing skills, 10 health research spending, 63 historical development, 27-28, 64-65, 197 human research programs, 58 industry-sponsored research, 109-111, 197, 198 Medical Scientist Training Program, 11, 12, 152 minority access to science careers, 134-136 NIH extramural research, 72-77 NIH human research, 81-95 NIH research centers, 95-96 nonprofit organizations, research spending in, 106, 107, 108 postdoctoral research training, 171-178 precollege science preparation, 130-131 privately supported research training, 189 research career development awards, 184-185 research training programs, 11, 151, 192 social context, 202 support of newly independent investigators, 8, 53 in surgical career, 291-292 third-party payers in clinical research, 112-118 training in, 192 training related to subsequent grant success, 178, 182-184, 186 tuition debt relief, 12-13, 189 undergraduate science preparation, 134-136 Funding Health Sciences Research: A Strategy to Restore Balance, 31

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Careers in Clinical Research: Obstacles and Opportunities G General Clinical Research Centers evaluation of, 194 funding, 97 future of, 97 historical development, 96, 97 number of, 9 organizational structure, 96 recommendations, 9, 12 research activities in, 97 role of, 96 training of researchers in, 97, 186 Genetic engineering, 1-2, 26 Genome mapping, 1, 23, 26 Government-University-Industry Research Roundtable, 119 Grant preparation, 10 as distraction from research, 74-76 training in, 192 H Harvard Clinical Effectiveness Program, 189, 191 Health care reform, 23-24 clinical research and, 2, 5, 8, 18, 41-42 medical innovation and, 110 support for clinical research and, 118 Howard Hughes Medical Center, 108-109, 151 Human immunodeficiency virus, 2, 24, 97, 98, 99 Human research activities in, 36, 93 cost of, 79 data needs, 7 definition, 3, 93 diversity of, 3 in F32 awards, 173-175 in K awards, 185 in NIH, 81-95 R01 grants for, 5, 39, 185 recommendations for NIH in, 6-7, 8, 9-11, 12-13 resources assessment, 29-30 See also Clinical research I Imaging technology, 23 Incentives for research career in development of research infrastructure, 14-15, 28 mentor role, 58-59, 168-169 need for, 6 professional recognition, 13-14 recommendations, 12-13 tuition debt relief, 12-13, 190 See also Disincentives for research career Intellectual property rights, 199, 204, 207 in academic-industry linkages, 210-212 corporations owned by academic institutions, 206 Internal medicine, 166 J J. David Gladstone Foundation Laboratories for Cardiovascular Disease , 108 Johns Hopkins University, 56, 151, 192 Joint Commission for Accreditation of Health Care Organizations, 16 K K awards, 10, 170, 184-185 L Legal issues in academic-industry linkages, 212 antitrust law and cooperative research, 119 intellectual property rights, 199, 204, 207, 210-212 reimbursement issues, 113-114 Liaison Committee for Medical Education, 16, 17, 167

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Careers in Clinical Research: Obstacles and Opportunities M Managed care, 110 Managed competition, 5 March of Dimes-Birth Defects Foundation, 107 Mayo Clinic, 191 McMaster University, 192 M.D.s dual-degree program, 151-152 laboratory-research training, 150 medical school faculty, 44-46, 50 in Medical Scientist Training Program, 154 as NIH grant recipients, 28, 77-79, 85, 172, 173, 175-176, 178 in NIH peer review groups, 82 number of, 44-45 postdoctoral training, 182-184 research training after medical school, 163 See also Postgraduate medical education Medicaid, 112 Medical research organizations, 108-109 Medical school(s) accreditation, 167 costs, 21, 156-160 curriculum, 15, 17, 145-147 dual-degree programs, 151-152 faculty, clinical or preclinical distribution of, 45-46 faculty degrees, 45 faculty demographics, 46-48 faculty growth, 28, 43-44 faculty research activity, 50 historical development, 42-43, 142-143 laboratory training in, 146 Medical Scientist Training Program in, 152-155 model training programs, 189-192 postgraduate research training, 160-170 in promoting research careers, 144-145 research training programs in, 151 student demographics, 143-144 student exposure to research, 15, 148-150 student interest in research, 145, 147-148 time demands in, and research, 150 tuition debt relief, 12-13, 189 See also Academic health centers Medical Scientist Training Program, 11, 12, 152-155 Medicare, 21, 64, 110, 112 Minorities in clinical psychology, 270, 276 in medical school, 143-144 on medical school faculty, 49-50 in medicine, 127 in surgical science, 289-290, 297-298 in undergraduate science, 134, 136, 137 Molecular biology, 1-2, 25 Multidisciplinary research, 8, 61 Muscular Dystrophy Association, 107 N National Center for Health Statistics, 99 National Center for Nursing Research, 3 National Easter Seal Society, 107 National Health Service Corps, 157-159 National Institute of Mental Health, 271 National Institute of Occupational Safety and Health, 98-99 National Institute on Disability and Rehabilitation Research, 104 National Institutes of Health (NIH), 131 appropriations to, 9-10 biotechnology research, 111 budget history, 67, 76-77 Computerized Retrieval of Information on Research Projects, 88-90 data collection, 7, 82-84 degrees of grant recipients, 77-79, 85 in evaluation of training programs, 10, 11 extramural research, 67-69, 72-77

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Careers in Clinical Research: Obstacles and Opportunities General Clinical Research Centers, 96-97 grant applications received by, 78, 84-85 human research funding, 81-95 intramural research, 67, 69-72 Medical Scientist Training Program, 152-155 Minority Access to Research Careers program, 134 Minority Biomedical Research Support, 136 multidisciplinary research in, 8 Office of Medical Applications of Research data, 87-88 oversight role, 7 peer review process, 77, 79-82, 282, 285-286, 295-296 postdoctoral research training in, 170, 171-176, 180-184 recommendations for, 6-7, 8, 9-11, 12-13 research career development awards, 10, 184-185 research settings, 8, 95-98 Research Supplements for Underrepresented Minorities, 136 study sections, 7, 81-82, 282, 285-286, 295-296 surgical research in, 285-286, 290, 298-299 in training of researchers, 71, 178-180 National Oceanic and Atmospheric Administration, 131 National Research Service Awards, 30, 170 National Science Foundation, 12, 67, 131, 136, 137 Research Experiences for Undergraduates, 134-136 New investigators, 8, 53 Nonprofit organizations, 106-109 Nursing clinical research in, 3, 253-264 doctoral programs, 124 training, 142 O Outcomes research in Agency for Health Care Policy and Research, 100-101 in dentistry, 250 General Clinical Research Centers for, 9 in human research, 81 role of, 2, 27 status of, 41 third-party payers in, 116 Oversight of academic-industry linkages, 20, 215 current problems in, 5, 18-19 interorganizational interdisciplinary group for, 117 model of, 118-121 of NIH study sections, 7 recommendations, 6, 19-20 P Patent & Trademarks Act, 199 Patient-oriented clinical research. See Human research Peer Evaluation of Extramural Research, 7 Peer review, NIH, 7, 77, 79-82, 282, 285-286, 295-296 Pharmaceutical industry corporations owned by academic institutions, 206 new drug development, 109, 110 reimbursement concerns, 115 research spending, 109, 110, 197, 209 Ph.D.s dual-degree programs, 151 educational debt, 189 on medical school faculty, 45-46, 50, 55 as NIH grant recipients, 28, 77-79, 85, 172-176, 178, 182 in nursing, 257-259 training, 150, 161-162, 182-184 Positional cloning, 1

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Careers in Clinical Research: Obstacles and Opportunities Postgraduate medical education design of research programs in, 161-163 mentoring in, 168-169 quality of research training in, 167-168 recommendations, 16 residency review committees in, 164-165 role of research training in, 160-161 specialty certification, 166-167 timing of research training in, 169-170 Primary and secondary school science, 125, 126 classroom experience, 127-129 evaluation of, 132 federal programs, 131 role of, 127 science fairs, 129 special initiatives, 129-130 teacher preparation, 128 trends, 130-131 Private sector in clinical research oversight, 6, 18-19 clinical researchers in, 42, 208-209 corporations owned by academic institutions, 206 in funding of evaluative science centers, 11 in funding of research training, 11 health research spending, 63, 65 industry-sponsored research, 63, 109-111, 197-198 medical research organizations, 108-109 medical school research programs funded by, 151 nonprofit organizations, 106-109 research culture in, 201-202 research training in, 170-171, 189-190 voluntary health agencies, 107 See also Academic-industry linkages Prostate hypertrophy, 27 Psychology clinical research in, 265-278 training, 142 R R01 grants, 72 award size, 76 distribution of, 84-95 duration of, 74-76 evaluation of, 39 human research in, 5, 39, 185 Research design historical development, 25 human studies, unique features of, 79-81 obstacles in clinical studies, 55, 57 resource demands, 5 subject enrollment, 42 third-party payers in, 116 training in, 162-163, 167, 191-192 Research infrastructure in academic settings, 14-15, 60-61 as career path incentive, 60 Residency review committees, 17, 164-165 Resources for Clinical Investigation, 30 Review of the National Institutes of Health Biomedical Research Training Programs, 176-177 Robert Wood Johnson Clinical Scholars Program, 189, 190 Role model or mentoring relationships, 4 faculty responsibility and, 193 good qualities in, 59 institutional recognition of, 14 postgraduate medical education, 168-169 role of, 58-59 in surgical careers, 291, 296 Rush Medical College, 146 S Science fairs and competitions, 129 SEMATECH, 119-120, 205 Stanford University, 191 Surgical research barriers to, 287-290 current status of, 281

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Careers in Clinical Research: Obstacles and Opportunities Medical Scientist Training Program and, 154 resource base, 284-287 strategies for improving, 281-283, 293-299 types of, 283-284 T T32 awards, 10, 170, 171, 178 T35 grants, 151 Technology assessment, 21, 114-115 Technology development, 1-2, 23, 123 academic health centers in, 21 in academic research culture, 201 clinical research and, 2 in commercial research culture, 201-202 commercialization of academic research, 205-206 health care reform and, 110 intellectual property rights, 199 outcomes research and, 2, 21 regionalization of, 21 Technology transfer, 20 academic-industry collaboration, 20, 205 biotechnology, 199 federal initiatives, 198 training for, 28, 216 Third-party payers clinical research and, 64, 112-114, 117-118, 121 concerns of, 114-116 data collection by, 116-117 in research design and data analysis, 116-117 support for academic health centers, 20-21 Training for research in clinical psychology, 265-266, 269-278 in dentistry, 124, 244-247 in Department of Veterans Affairs, 103 in dual-degree programs, 151-152 duration of, 4, 12, 42, 150, 161-163, 169-170, 183 effecting change in, 194-195 faculty needs, 193-194 federally supported non-NIH, 188-189 in General Clinical Research Centers, 97 goals of, 124-125 historical development, 43-44 importance of, 193-194 laboratory-based model, 57-58 laboratory experience, 150 in medical school, 123-124, 145-147, 151, 191-192 in Medical Scientist Training Program, 152-155 medical student interest in, 145, 147-148 model programs, 10-11, 188, 190-192 NIH intramural programs in, 71 in nursing, 257-264 obstacles to, 125-126, 168-170 postdoctoral, 161-163, 170-176, 180-184 postgraduate, 16, 160-170 primary and secondary school preparation, 125, 126, 127-132 in private sector, 170-171 privately funded, 189-190 program evaluation, 10-11, 12, 17, 18, 176-180, 194 recommendations, 10-11 recruitment for, 176-177 research methodology, 162-163, 191-192 residency review committee requirements, 264-265 scientific ethics as element of, 155, 192 social demographic context, 125, 126-127 specialty board certification and, 166-167 status of, 4, 5 subsequent grant success and, 178, 182-184, 186 in surgery, 287-292, 298-299

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Careers in Clinical Research: Obstacles and Opportunities technology transfer as element of, 216 trends, 28-29 undergraduate student preparation, 132-142 Tufts University, 56 U Undergraduate science preparation criticisms of, 136-137 design of, 138-140 effectiveness of, 137-138 federal programs, 134-136 improvements in, 141-142 institutional efforts, 133 role of, 140-141 science majors, 132 University of California, 191 University of Kentucky, 133, 140 University of Michigan, 55, 190-191 University of Pennsylvania, 151 University of Puerto Rico, 140 V Voluntary health agencies, 107 W Washington University, 151 Women in clinical psychology, 270, 275-276 in clinical research, 48-49 on medical school faculty, 46-48, 49-50 physicians, 44-45, 48-49, 127, 143 in surgical science, 282-283, 289, 297 in undergraduate science, 136-137