Careers in Clinical Research Obstacles and Opportunities (1994) / Chapter Skim
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Training Pathways
Training Pathways
Pages 123-196
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From page 123... ...
system of undergraduate and graduate medical education, including a growing divergence between patient needs and physician training; excessive emphasis on research and service in research-intensive universities at the expense of teaching; poor integration between Me preclinical and clinical components of medical education; changes in hospital-based clinical training and Me move to more ambulatory care, as a reult of which trainees are unable to observe the entire course of disease; and a teaching style that fails to engender the development of faculty role models or imbue students with problem-solving skills and positive attitudes for lifelong learning (Cantor et al., 1991; Goodman et al., 1991~. Moreover, along with the growing 123
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From page 124... ...
Dentistry, nursing, and other health professional groups also encounter barriers to clinical research careers that may or may not be similar to the barriers found in medicine. For example, unlike medicine, where there is extensive graduate medical education, the dental school curriculum is designed to prepare dentists who can practice dentistry upon graduation—after four years of graduate education.
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From page 125... ...
The committee examined the recruitment into scientific careers and the retention of those interested in pursuing research careers. Clearly, issues that affect students early are the quality and quantity of hands-on research experiences that are directly related to resources and quality of teaching.
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From page 126... ...
It should be noted, however, that the committee has been hindered in its analyses by the extreme lack of outcomes data for research training programs and for factors affecting career choice. Although the audience for this report might question the relevance of K-12 science experiences and their relationship to clinical research careers, the committee felt that it was important to reemphasize obstacles throughout the entire education and training pathways for clinical investigators.
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From page 127... ...
The committee believes that life experiences and the quality of science education during the formative years have a profound effect on the future talent pool from which highly capable clinical investigators will be drawn at later stages of the education pathway.
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Elementary school teachers often are expected to teach science and mathematics, yet they have taken little or no course work in these subjects. High school math and science teachers are less likely, on average, than teachers in other fields to have concentrated in their primary teaching field during college (Federal Coordinating Council on Science, Engineering and Technology, 1991~.
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From page 129... ...
, and church groups (Matyas and Malcom, 1991~. Parents can also facilitate 1 Both the International Science and Engineering Fair and the Westinghouse Talent Search are conducted through Science Service, Inc., Washington, D.C.
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Student research experiences also can be indirectly affected by programs aimed at improving the science literacy of teachers and parents. In-service programs, for example, can help teachers acquire knowledge of content and teaching methods to incorporate laboratory components into the science curriculum.
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From page 131... ...
The NIH's Biomedical Research Assistant Saturday Scholars program, for example, involves 90 junior and senior high school students in hands-on laboratory activities on Saturday mornings. NIH has also initiated a new program called the Science Education Partnership program to encourage careers in the biomedical sciences.
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NSF also encourages minority student involvement in research through its Summer Science Camps and Comprehensive Regional Centers for Minorities. Nonfederal Programs There is also a significant nonfederal attempt to provide research experiences to precollege students.
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, fewer than 40 percent of students initially majoring in biology received their degrees; the remainder either obtained non-science degrees or dropped out of college. The committee believes that few, if any, students who are turned off to science at He time they enter college will pursue research careers.
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sponsors the Minority Access to Research Careers (MARC) program, a major component of which is the Honors Undergraduate Research Program.
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Summer Intern Program Minority Research Apprentice Program Cooperative Education Program Federal Junior Fellowship Program Baccalaureate Cooperative Education Program Advanced Design Program Research Experiences for Undergraduates (REU) Research Careers for Minority Scholars Engineering Senior Design Projects to Aid the Disabled Source: Matyas, 1994.
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From page 136... ...
It is unclear, however, how many of these minority physicians have joined the faculty ranks or have become clinical investigators in other employment sectors such as government or industry. The NSF's Research Experiences for Undergraduates (REU)
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From page 137... ...
The committee is unaware of any similar effort to draw the disabled into medical research careers. When majority and minority groups are taken as a whole, academic institutions and federal agencies are most likely to facilitate the involvement of students in nonengineering research activities.
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More recently, however, sponsors have begun to encourage and even require more extensive program evaluation and outcomes assessments. Results obtained by those programs that have conducted formal evaluations indicate that the effects of early research experiences appear to have been positive.
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From page 139... ...
For example, if the goal of the program is to conform the research career goals of students who are any high achievers and highly motivated, research experiences that occur late in the undergraduate period will be beneficial. If one of Me goals is to entice students who may have little natural interest in research, then earlier research experiences—starting in the precollege and early undergraduate years— will be more effective.
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From page 140... ...
Characteristics of Successful Programs Programs designed to encourage precollege and undergraduate students to pursue careers in the sciences—particularly in clinical research will be successful only if their component activities and the strategies for carrying them out are effective. A number of studies have attempted to define the characteristics of successful programs (George et al., 1987; Lockheed et al., l9X5; Malcom, l9X3; Matyas and Malcom, 1991)
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From page 141... ...
and support from the community of teachers and counselors · Absence of educational inequities based on gender, race, ethnicity, or disability · A strong program director and committed and stable (low-turnover) staff that shares the program's goals · A stable, long-term funding base with multiple funding sources, including the host institution · Financial support for participants, including such things as program fee waivers, stipends, or scholarships · Sufficient time to actively recruit and identify program participants · valuation, long-term follow-up, and careful data Collection · The integration into the institution's regular activities of program elements shown to encourage student participation in research programs for K-12, undergraduate, and graduate students; partnerships and research programs for teachers; and community outreach efforts, such as a science telephone hotline for student questions and a computer bulletin board' Science Spoken Here.
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From page 142... ...
This should not be perceived as a lowering of standards to reach the second tier; rather, programs should be developed to encourage academic achievement and inspire these students to pursue health professional and clinical investigative careers. Finally, there need to be systemic changes in science education at both He precollege and undergraduate levels so Hat research is not a special activity for only a few select students during a few weeks in the summer.
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From page 143... ...
Thus, between the mid-1950s and the mid-1970s the number of medical schools grew from 83 to 114. Over the same period, the number of available slots in medical schools nearly doubled from about 8,000 to 15,000.
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Although the previous discussion examined the quantitative aspect of the physician talent pool, the committee was concerned about the qualitative issues for encouraging medical students to pursue research careers, particularly clinical investigative careers. A recent survey of medical students, house staff, and junior faculty at the University of California, San Francisco, revealed three commonly perceived disadvantages to an academic career involving research: (1)
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From page 145... ...
In addition, career decisions involving two professionals married to each other often work against the decision to enter research Paining or a research career. Thus, the committee posed several questions about the effectiveness of medical education in promoting clinical research careers.
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Medical School Science Curriculum and Culture Today, medical education centers on the accumulation of an ever-increasing number of facts. Medical students are measured by their ability to recount these facts, often at the expense of enhancing their analytical skills.
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From page 147... ...
Fewer didactic lectures, more small-group teaching, increased supervision of students learning clinical skills, and more interdisciplinary efforts that emphasize making basic science relevant to the clinical practice of medicine are among the efforts under way in the nation's skills, · limited instruction in assessing the medical literature in the preclinical curriculum, · an overcrowded schedule of lectures and laboratory sessions, frequently coupled with poor attendance by students, · limited direct orientation of basic science education to a clinical career, medical schools (Association of American Medical Schools, 1984, 1992b; Jonas et al., 1991~. Few schools, however, have a specific curriculum requirement for research.
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From page 148... ...
These results are not surprising; this probably represents a fraction of students who have, for some reason, chosen to pursue research careers rawer than patient care. Far more fourth-year medical students 27 to 28 percent indicate a preference for a full-time academic appointment in clinical science rather than basic science.
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Research Participation by Medical Students When to undertake research training remains a point of controversy if one chooses to become a clinical investigator. Although some studies have questioned whether medical school research experiences are a factor in generating
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If research experience during medical school is a reasonable predictor of postgraduate research activity, the opportunity to take time off for research during medical school or during the first full year following receipt of the M.D. degree has the potential to encourage more physicians to pursue research pathways than programs providing brief research experiences during Me residency and fellowship years.
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From page 151... ...
For example, NIH sponsors a short-term training grant program (referred to as a T35 training grant) to medical schools to support brief training experiences for medical students (predoctoral professional students are not generally appointed on institutional National Research Service Award training grants [T321~.
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Dual-Degree Programs One approach to increasing the supply of physicians trained to conduct research is the development of dual-degree programs. Many medical schools offer students the opportunity to earn graduate and professional degrees in addition to the doctor of medicine degree.
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Approximately 1,500 students were enrolled in these programs (Martin, 1991~. NIGMS funds MST programs at only 29 of the medical schools, accounting for about 700 students annually (Figure 4-1~.
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One survey of 148 MST program graduates from Washington University found 86 percent of those who completed their postgraduate training were employed in academic positions. Of this group, nearly two thirds were employed in clinical departments, 69 percent had received NIH grants, 11 percent were Howard Hughes Medical Institute investigators, and 6 percent were recipients of clinician-scientist awards from Pfizer or Squibb (Freiden and Fox, 1991~.
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From page 155... ...
of MST program participants who have taken academic or institute research positions. Nevertheless, there have been no systematic analyses of the significance of research exposure in medical school in deciding on a research career, that is, how many students who were not previously so inclined turn to science as a result of such exposure.
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Training in Research Ethics Insufficient laboratory experiences and deficiencies in those experiences are not the only dilemmas experienced by physicians who choose research pathways. Scientific ethics should be introduced at some point in training for all individuals wishing to become scientists.
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Financing and Debt The rapidly growing indebtedness of medical students is raising serious concerns throughout the medical education community. The committee felt strongly that the rising debt levels of medical students are deterring individuals from pursuing research careers.
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From page 158... ...
of debt on a career decision during residency training are largely unknown, an examination of inquires regarding career choice and interest in research $ the time of medical school graduation have not lent support to this concern. The committee reviewed the responses provided through He Association of American Medical Colleges Graduation Questionnaire.
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and percent of medical school graduates with educational debt (bottom panel)
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Washington, D.C. The mean educational debt levels for 1988, 1989, and 1990 medical school graduates who expect significant involvement in research during their medical careers is below the mean debt for all indebted medical graduates.
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Linda Blank of the American Board of Internal Medicine drafted a paper on He roles of the resident review committees and the certification boards on research career pathways (Blank 1994) , and Judith Swazey prepared a paper on mentors and role models (Swazey, 1994~.
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From page 162... ...
It was the model employed by many who are clinical investigators today. The drawback of this model is that by the time a student has completed training, he or she might have already decided on a clinical career without being exposed to research, and some of the flexibility in the system is thus lost.
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From page 163... ...
Furthermore, many clinical fellows have no coursework requirements and have no contact with basic scientists or clinical investigators. These problems point to the need for more training of physician-scientists where the research is conducted, as well as the need for formal, rigorous course work.
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From page 164... ...
and certifying boards have in promoting or hindering research careers among physicians. Both organizations have the ability to establish requirements for research training in medical subspecialties, although neither provides funding or an organizational framework to accomplish this.
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From page 165... ...
The executive secretaries of all 24 RRCs were surveyed to determine which program standards for formal training (so-called special requirements) include research experiences to obtain a description of the research criteria, to confirm the status of the research experience and documentation, and to describe any planned changes in He research experience.
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From page 166... ...
Research experience is not required for certification, although two boards—for preventive medicine and pediatrics- recognize research as an important element of clinical training. All 24 member boards of the American Board of Medical Specialties were surveyed to assess the availability of certification pathways for physicians who seek careers in clinical investigation, the number of candidates who use these pathways, examination performances, outcomes, and any expected changes in the pathways and impacts of cer~cation and recertification for specialist who choose a career in clinical investigation (Blank, 1994~.
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From page 167... ...
These programs are still too new to measure their effects on the careers of clinical researchers. The committee is very concerned that if clinical investigators, many of whom have very narrow academic interests, are required to maintain a broad-based practice to meet recertification requirements in 10-year increments, clinical research may suffer.
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With only 24 schools of public health and 126 medical schools in the United States, however, a minority of postdoctoral training programs have access to these resources.
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From page 169... ...
However, the committee believes that mentors who commit themselves to advising and guiding trainees through the maze of research are critical players in the research careers of young investigators. The committee also believes that some form of midcareer program to aid established investigators in becoming more effective mentors could help alleviate He shortage of clinical investigator mentors that now exists.
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From page 170... ...
Thus, a different type of reward system may be warranted since publication may not be the currency of achievement for those clinical research trainees involved in long-term research projects. Consistent and continuous involvement in clinical research activity throughout the training period might be one option for maintaining an interest and gaining an aptitude for clinical research—an objective that runs counter to the training requirements of residency review committees and certification boards noted earlier (Blank, 1994~.
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From page 171... ...
In addition, a small number of programs around the country—supported by foundations and academic institutions are taking innovative steps to improve the competence of clinical investigators. (See the section Model Programs for Research Training later in this chapter and the background papers by Atkins et al., 1994, and Lee and Goldman, 1994.)
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From page 172... ...
candidates, tuition support is not necessarily provided under the grants that support postdoctoral studen~the stage when many physician-scientists require it. Although NIH institutional training grants may permit the inclusion of some tuition expenses, these must be anticipated in advance and may not be available from grants already in force.
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(Source: National Institutes of Health, 1993b.) 88.1% in institutional award programs Input Chard programs 1 59.1.1% in I insbtubonal wad programs 2,651 M.D.s \ 40.9°/0 in \ individual 3,163 Ph.D.s FIGURE 4-6 Distribution of NIH postdoctoral training positions between individual and institutional training grants for M.D.s and Ph.D.s in 1992.
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From page 174... ...
Number of Applications Rates Award Type and Year Reviewed Approved Awarded Approval Award Success Training grant awards 1977 306 250 145 82 58 48 1978 277 235 173 85 74 60 1979 175 133 77 76 58 44 1980 271 248 200 92 81 74 1981 179 162 103 91 63 56 1982 197 190 131 96 69 63 1983 192 184 152 96 83 78 1984 161 146 91 91 62 57 1985 288 276 200 96 72 69 1986 211 191 96 91 50 45 1987 222 219 144 99 66 63 1988 272 257 139 95 54 51 1989 183 178 99 97 56 54 Mean 226 135 94 65 59 Fellowship awards 1977 252 214 132 85 62 52 1978 334 279 168 84 60 50 1979 311 264 164 85 62 53 1980 310 269 137 87 51 44 1981 324 267 122 82 46 38 1982 290 253 137 87 54 47 1983 297 270 147 91 54 50 1984 362 326 151 90 46 42 1985 428 384 198 90 52 46 1986 436 401 147 92 37 34 1987 364 345 163 95 47 44 1988 396 376 166 95 44 42 1989 489 472 144 97 30 29 Mean 353 152 90 51 45 Source: Repnnted, win permission, from Ahrens (1992~. Copyright 1992 by the Oxford University Press, Inc.
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From page 175... ...
to Principal Investigators with an M.D. Number of Applications Rates Award Type and Year Reviewed Approved Awar~d Approval Award Success Training grant awards 1977 352 246 130 70 53 37 1978 289 232 150 80 65 49 1979 255 186 96 73 52 37 1980 298 273 176 92 65 57 1981 135 122 62 90 51 43 1982 181 168 94 93 56 51 1983 210 192 131 91 68 60 1984 171 158 87 92 55 50 1985 261 253 164 97 65 62 1986 160 149 61 93 41 38 1987 180 176 114 98 65 60 1988 235 225 133 96 59 56 1989 244 242 112 99 46 45 Mean 229 116 94 57 50 Fellowship awards 1977 1,332 1,165 747 87 64 56 1978 1,463 1,290 876 88 68 60 1979 1,667 1,502 945 90 63 56 1980 1,421 1,277 649 90 51 45 1981 1,474 1,292 485 88 38 33 1982 1,500 1,339 619 89 46 41 1983 1,439- 1,296 628 90 49 44 1984 1,452 1,324 543 91 41 37 1985 1,602 1,512 709 94 47 44 1986 1,575 1,478 415 94 28 26 1987 1,468 1,444 700 98 49 47 1988 1,430 1,384 600 97 43 42 1989 1,648 1,588 468 96 30 28 Mean 1,498 645 92 49 44 Source: Repnnted, win permission, Tom Ahrens (1992)
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From page 176... ...
Because the training grants are awarded to institutions and managed locally, it is not possible to determine the nature of the training. The fellowship applications, however, must pass through the same institutional review board process as regular grant applications, and they are so identified on the cover sheet of the application.
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From page 177... ...
If the fellowship awards for studies indicating the use of humans or human materials show the same pattern as the committee's analysis of RO1 grants, which found that only about one-third of the awards indicating the use of human subjects or human materials would be for patient-oriented research, then less than 50 of the more than 300 F32 awards made annually to M.D.s are likely to be for research involving patient contact. Although NIH has tracked the number of M.D.
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From page 178... ...
FIGURE 4-9 Number of NIH individual fellowship ~32 award) applications by all applicants for studies involving the use of human subjects or human materials and those not using human subjects or materials.
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From page 179... ...
applications by M.D. applicants for studies involving the use of human subjects or human materials and those not using human subjects or materials.
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From page 180... ...
applications by M.D. applicants for studies involving Be use of human subjects or human materials and those not using human subjects or materials.
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From page 181... ...
and Ph.D. trainees and fellows for NIH research grants.
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From page 182... ...
For example, successful investigators have had longer research experiences at each stage of their careers than those who have received training but have not chosen investigative careers Wee et al., 1991; Levey et al., 1988~. Similarly, medical school research experience was strongly associated with postgraduate research involvement (Segal et al., 1990)
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From page 183... ...
TRAINING PATHWAYS 183 TABLE 4-9 Percentage of F~rst-Time PhD. Grant Applicants and Recipients with Prior NIH-Supported Training, 1964 1989 Fiscal Year of first Applicants Recipients Trainee Trainee Application All All win win Application Award for award Applicants Recipients Training Training Rate Rate 1964 1,267 867 434 345 34.3 39.8 1965 19221 688 480 321 39.3 46.7 1966 1,254 660 547 328 43.6 49.7 1967 1,247 728 572 379 45.9 52.1 1968 1,176 527 617 321 52.5 60.9 1969 1,204 625 657 394 54.6 63.0 1970 1,369 483 832 337 60.8 69.8 1971 1,339 581 804 406 60.0 69.9 1972 1,458 803 824 552 56.5 68.7 1973 1,559 601 889 406 57.0 67.6 1974 1,692 1,087 980 725 57.9 66.7 1975 1,782 1,181 1,110 835 62.3 70.7 1976 1,975 917 1,193 629 60.4 68.6 1977 2,219 918 1,331 647 60.0 70.5 1978 2,222 1,247 1,377 852 62.0 68.3 1979 2,245 1,516 1,360 1,037 56.1 68.4 1980 2,370 1,169 1,427 801 60.2 68.5 1981 2,247 1,121 1,361 765 60.6 68.2 1982 2,396 1,109 1,500 804 62.6 72.5 1983 2,376 1,283 1,351 891 56.9 69.4 1984 2,321 1,264 1,327 854 57.2 67.6 1985 2,597 1,385 1,467 922 56.5 66.6 1986 2,651 1,467 1,377 892 51.9 60.8 1987 2,488 1,388 1,286 842 51.7 60.7 1988 2,763 1,453 1,322 862 47.8 59.3 1989 2,863 1,251 1,302 689 45.6 55.1 Source: Quantum Research Corporation, 1991.
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From page 184... ...
The findings have been fairly inconclusive because of the difficulties associated with retrospectively devising appropriate comparison groups with existing data. Physicians who have been recipients of National Research Service Award traineeships and fellowships have been contrasted with M.D.s without postdoctoral training and M.D.s who reported their primary activities to be research or teaching, but who had not pursued formal postdoctoral study.
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From page 185... ...
Research Career Development Awards NIH sponsors a series of career development awards including the PhysicianScientist Award (Ku award) , for M.D.s without prior research experience; a modified form of Be Research Career Development Award (K04 award)
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From page 186... ...
On the one hand, the K04 awards, which required previous research experiences, have declined by more than half over the past 10 years, from 787 in 1982 to 313 in 1992. On the other hand, He number of Clinical Investigator Awards (K08 awards)
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From page 187... ...
Given the nature of the program, it is likely that a high percentage of those funded are actively involved in patient-related clinical research. These results indicate Hat Be CAP program and He KOS award program are effective in training competitive clinical investigators.
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From page 188... ...
About 80 percent of the participants are physicians; other health professionals such as nurses and dentists with master's degrees in public health are also accepted into the program. One interesting aspect of the program is that the American Board of Preventive Medicine recognizes the training program fulfills the certification requirements of one year of supervised training and field experience.
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From page 189... ...
Effectiveness of these types of programs in preparing clinical investigators, rather than train individuals to assess regulatory requirements for new drugs and devices, is not known. Private Support There is no current, comprehensive source of information about private sources of funding for clinical research training.
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Payback of Debt As mentioned previously, many medical residents accrue a large amount of education-related debt from undergraduate and medical schools. Under the current rules, payback must begin in the third year of postgraduate training.
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Overview of Selected Programs Robert Wood Johnson Clinical Scholars Program One of the oldest, largest, and most successful of the existing research Raining programs is the Clinical Scholars Program (CSP) (Shuster et al., l9X3)
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From page 192... ...
with individual or institutional training grants or other institutional funds. Of the 80 physicians who have enrolled in the summer curriculum and who have finished their clinical training, 68 (85 percent)
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Salary support for fellows can be provided through customary subspecialty training grants, but support of faculty time is often problematic. Developing and sustaining these programs require a substantial commitment of faculty and administrative time.
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From page 194... ...
CONCLUSIONS In conclusion, the committee found that data do not exist to make an accurate assessment of the number of patient-oriented clinical investigators or the number who are being trained. Whereas career pathways for those choosing to pursue basic science investigation are clearly delineated, with established rewards and measures of productivity, comparable training pathways for patient-oriented clinical research careers are not.
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From page 195... ...
Once those programs are identified and suitable outcomes measures are determined, the programs that are effective in Gaining patient-oriented clinical investigators should be expanded. Some programs, such as the Clinical Associate Physician program, train this type of investigator by design.
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From page 196... ...
196 CAREERS me CLINICAL RESEARCH committee fears Mat failing to be proactive and addressing paining pathways at this critical juncture in science and its relationship to medical care could jeoE - ize future progress in biomedicine.
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