CHAPTER FIVE

PHYSICIAN-SCIENTISTS

Training in the clinical sciences is critical to maintaining our country's leadership in the translation of basic discoveries to meaningful patient care. As the nation demands more primary care of our physicians, we must not lose sight of the tremendous advances that have been made by individuals using basic approaches to explore interesting and significant clinical problems.

Clinical research includes a spectrum of investigation. At one end, it is represented by the use of basic scientific approaches and tissue samples from patients or normal individuals to generate fundamental insights into the disease process. At the other end, it is represented by studies in which whole patients, normal volunteers, or populations of subjects each serve as the laboratory.1

The clinical investigator generally has an M.D. or other health professional doctorate, although the committee recognizes that basic scientists also participate in clinical investigation. The committee has based its assessment of national need on the fact that most government-sponsored research in the clinical sciences is performed in medical schools or academic health centers (Appendix Table F-22). The ability of medical schools to conduct clinical research depends largely on the continuing availability of clinical faculty with strong research skills. The future availability of well-prepared clinical research faculty has come into question by a number of authors (Ahrens, 1992; Fredrickson, 1993; IOM, 1994). Given continuing national concern over the future supply of skilled clinical investigators, we have restricted our analyses in this chapter to the need for physician-scientists.2

Previous National Research Council (NRC) study committees have focused on the special role that the physicianscientist has played in bringing clinical insights to bear in the laboratory and in translating new knowledge into the context of medical practice (NRC, 1981). Almost all NRC committees that have addressed research training needs in the clinical sciences have observed that there continues to be a shortage of physicians willing to prepare for research careers. Many committees have focused on the very real effects of competing—and more lucrative—opportunities available in private practice as a reason for this trend (NRC, 1978). More recently, some committees have observed that changes occurring in the way medical schools finance their operations and structure their faculties simply does not provide an environment conducive to preparation for a research career (NRC, 1985). We concur and provide evidence elsewhere in this chapter suggesting that upcoming changes in the national support for health research and health care reform may further erode research and research-training opportunities in academic health centers.

In addition to these contextual variables, we believe the nature and timing of National Research Service Award support may directly effect the success of recruiting physicians into research careers. On the basis of information gathered by the National Institutes of Health (NIH), we believe that the Medical Scientist Training Program (MSTP) may be especially effective in launching individuals into research careers. This program was established in 1964 to permit individuals to pursue the M.D. and the Ph.D. degrees concurrently. The MSTP program has consistently had a high proportion of graduates involved in research and actively contributing to the advancement of the clinical sciences. (See also, Appendix A for a summary of available outcome studies.)

Opportunities for careers in clinical research abound. Our continuing challenge is to stimulate interest of clinicians in contributing to that effort, and the NRSA program can clearly play a role relative to that goal.3 In the sections that follow, we will review some of the more exciting advances in clinical science that create the need for a continu-



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CHAPTER FIVE PHYSICIAN-SCIENTISTS Training in the clinical sciences is critical to maintaining our country's leadership in the translation of basic discoveries to meaningful patient care. As the nation demands more primary care of our physicians, we must not lose sight of the tremendous advances that have been made by individuals using basic approaches to explore interesting and significant clinical problems. Clinical research includes a spectrum of investigation. At one end, it is represented by the use of basic scientific approaches and tissue samples from patients or normal individuals to generate fundamental insights into the disease process. At the other end, it is represented by studies in which whole patients, normal volunteers, or populations of subjects each serve as the laboratory.1 The clinical investigator generally has an M.D. or other health professional doctorate, although the committee recognizes that basic scientists also participate in clinical investigation. The committee has based its assessment of national need on the fact that most government-sponsored research in the clinical sciences is performed in medical schools or academic health centers (Appendix Table F-22). The ability of medical schools to conduct clinical research depends largely on the continuing availability of clinical faculty with strong research skills. The future availability of well-prepared clinical research faculty has come into question by a number of authors (Ahrens, 1992; Fredrickson, 1993; IOM, 1994). Given continuing national concern over the future supply of skilled clinical investigators, we have restricted our analyses in this chapter to the need for physician-scientists.2 Previous National Research Council (NRC) study committees have focused on the special role that the physicianscientist has played in bringing clinical insights to bear in the laboratory and in translating new knowledge into the context of medical practice (NRC, 1981). Almost all NRC committees that have addressed research training needs in the clinical sciences have observed that there continues to be a shortage of physicians willing to prepare for research careers. Many committees have focused on the very real effects of competing—and more lucrative—opportunities available in private practice as a reason for this trend (NRC, 1978). More recently, some committees have observed that changes occurring in the way medical schools finance their operations and structure their faculties simply does not provide an environment conducive to preparation for a research career (NRC, 1985). We concur and provide evidence elsewhere in this chapter suggesting that upcoming changes in the national support for health research and health care reform may further erode research and research-training opportunities in academic health centers. In addition to these contextual variables, we believe the nature and timing of National Research Service Award support may directly effect the success of recruiting physicians into research careers. On the basis of information gathered by the National Institutes of Health (NIH), we believe that the Medical Scientist Training Program (MSTP) may be especially effective in launching individuals into research careers. This program was established in 1964 to permit individuals to pursue the M.D. and the Ph.D. degrees concurrently. The MSTP program has consistently had a high proportion of graduates involved in research and actively contributing to the advancement of the clinical sciences. (See also, Appendix A for a summary of available outcome studies.) Opportunities for careers in clinical research abound. Our continuing challenge is to stimulate interest of clinicians in contributing to that effort, and the NRSA program can clearly play a role relative to that goal.3 In the sections that follow, we will review some of the more exciting advances in clinical science that create the need for a continu-

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ing research effort, summarize the current market for these scientists, and recommend specific changes in the NRSA program that may be effective in expanding the cadre of physician-scientists needed at this time. ADVANCES IN CLINICAL SCIENCE Advances in clinical science have been enormous and include, but are not limited, to the following: Identification of the genetic defect in various genetic disorders, including cystic fibrosis. Cystic fibrosis is the most common genetic disorder in Caucasians, affecting 1 of every 2,000 children. The disease is characterized by pulmonary infections and pancreatic insufficiency and is due to a cellular defect in the development of secretions. The genetic defect associated with the disorder is found in chromosome 7. This discovery allows three major advances. First, it allows genetic counseling within families. Second, it has allowed a determination of the product of the gene. This information will provide a rational approach to developing drugs to correct the defect. Finally, it will allow studies that attempt to replace the defective gene with a normal one in tissues that are affected. Indeed, such somatic gene therapy has already begun. Identification of the gene associated with bowel cancer. Very recently, two separate groups of investigators demonstrated a genetic defect localized to chromosome 2, which is associated with hereditary nonpolyposis colon cancer. The gene involved appears to control DNA repair, and a defective gene seen in patients with colon cancer leads to instability of cellular DNA. This research is a spectacular example of the different ways in which basic research can lead to clinical advances. In one laboratory the research developed from studies performed in yeast and bacteria that examined how these organisms repair DNA and the genetic defects associated with DNA instability. In another laboratory there is a long history of studies in humans examining genetic defects associated with a variety of colon cancer syndromes. In other words, this remarkable advance in our understanding of colon cancer came from distinct pathways, one originating from basic studies of normal mechanisms in bacteria and yeast and the other from more clinically oriented studies looking at abnormal growth and differentiation of colon cells. These studies will allow the development of reagents that can be used to screen for colon cancer. Creation of an animal model for ankylosis spondylitis by using transgene methodology. Ankylosis spondylitis is a syndrome that predominantly affects joints of the spine. Approximately two decades ago it could be demonstrated that the disease was significantly associated with a specific HLA type, HLA-B27. Indeed, 90 percent of patients with ankylosis spondylitis had the HLA-B27 genotype. In an attempt to demonstrate the nature of the association between the gene and the disease, investigators established a rat model in which the human HLA-B27 gene was inserted by using transgene methodology. In some of the animals a disease developed that mimicked human ankylosis spondylitis. These animals not only provide a model for determining just how the gene influences the expression of the disease but also for deciding what other factors may be involved. They also provide a model for studying the effectiveness of various forms of therapy. The importance of clinical research to advancing our understanding of clinical disorders is captured in a recent editorial in Science written by Editor-in-Chief Daniel E. Koshland Jr. (1993): In the 1980s and 1990s NIH researchers, intramural and extramural, performed the first trial of gene therapy in humans, proved the effectiveness of methotrexate for treating rheumatoid arthritis, developed new methods for growing skin to repair burns, showed that control of glucose levels slows progression of diabetes, showed effectiveness of cholesterol reduction in the prevention of heart disease, demonstrated an effective treatment for spinal cord injury, found a new drug for Parkinson's disease, showed that aspirin and coumadin lower the risk of stroke, developed methods of hypertension control that have reduced heart attacks and strokes by more than 50 percent, and so on for many other discoveries. .... These followed many earlier discoveries, including the polio vaccine, the measles vaccine, hormone replacement therapy, fluoride to prevent tooth decay, to name a few. We are living longer, we are living with less pain, we are living with less cost to alleviate health deficiencies than any previous generation because of the findings of health researchers. .... In the not-so-distant past, smallpox epidemics killed 25 percent of the inhabitants of towns that were invaded by the virus. Today we are storing the last traces of the virum because that dread disease has been eradicated from the Earth. Clearly, this partial list of clinically relevant discoveries supports the practical value of clinical research. The United States is the world leader in clinical research and we must make a renewed commitment to retain this leadership. The recommendations of this report should allow us to remain in this position of preeminence. ASSESSMENT OF THE CURRENT MARKET FOR CLINICAL SCIENTISTS Degree Production and Career Patterns Clinical scientists work in a variety of settings but primarily in academic health centers. Between 1981 and 1991, the number of full-time faculty employed in clinical depart-

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ments grew by about 38,000 to just over 59,000 (Appendix Table F-23), suggesting that the market for clinical scientists remained relatively robust throughout the 1980s. Degree Production The major source of new physician-scientists is the nation's medical schools. The most readily available informarion about patterns of enrollment and degree production is the Association of American Medical Colleges (AAMC). Data from AAMC (Appendix Table F-23) reveals that medical school enrollments remained essentially flat between 1981 and 1991 at about 65,000 students. The number of medical degrees awarded each year also remained level at about 15,500 per year in the 1980s. Career Patterns Few data sets are available for sorting out the unique patterns of research careers among physician-scientists. The American Medical Association provides information about the number of physicians primarily engaged in research (Appendix Table F-23)—which fluctuated between 16,000 and 23,000 between 1981 and 1990. But these figures may also include trainees in graduate medical programs. Perhaps more telling is the trend in success rates of M.D.s who apply to the National Institutes of Health—which peaked at about 45 percent in 1987 and has leveled off at about 37 percent (on average) thereafter (Appendix Table F-23). Market Forces There are several influences on the availability of careers in clinical research. These influences, called market forces, range from how we have traditionally trained clinical researchers to outside industrial and governmental spending trends. As the nation begins to develop a new system of health care delivery, these market forces will become increasingly important. Academic Health Centers An academic health center can be defined as a medical school working in conjunction with a teaching hospital and at least one other health professional school to achieve mutually agreed upon goals for education, research, and provision of clinical care. Approximately 68 percent of NIH R01 support goes to these academic health centers. Academic health centers therefore constitute the major sites at which health-related research and research training are carried out. Moreover, a significant amount of their support for research is derived from income obtained for the provision of clinical care. This income stream is threatened by changes in healthcare reform that place academic health centers at a disadvantage with regard to the cost of providing medical care. This presents a threat to the market not only for training but also for support of trained investigators. Pharmaceutical and Biotechnology Industry Uncertainties in health care reform has forced industry to be exceedingly cautious with expenditures, and in some cases to lay off large numbers of employees. This posture clearly stifles innovation. One of the first areas to feel the effects of budgetary constraints is research. This soft side of the market has to be balanced by the fact that there are tremendous opportunities for the development of unique agents to treat significant clinical disorders. Cap on Domestic Spending The federal deficit, budget reconciliation, and a cap on domestic spending indicates that support for research and training will have to compete for many other high-priority areas supported by the domestic budget. This scenario is one in which the NIH budget is likely to grow at a rate certainly not greater and probably somewhat less than the biomedical research price index. Emphasis on Increasing the Training of Generalists There clearly is an enormous pressure nationally to increase the proportion of generalists in medicine and decrease the proportion of specialists. Heretofore, significant research training and research activity has occurred in association with specialties, particularly the medical specialties. Indeed, some view the problem in the imbalance of generalists to specialists as a result of overemphasis on research spending. This, therefore, provides a diminished enthusiasm among some to further increase funding for research or research training. OUTLOOK FOR CLINICAL SCIENTISTS In addition to market forces, there are factors that influence the demand for clinical scientists. These demand indicators are expenditures for clinical research and development (R&D) in medical schools; professional service income in medical schools; total revenue; budgeted vacancies in medical schools, both in clinical and basic science departments; and the clinical faculty/student ratio. Expenditures For Clinical Research and Development From 1985 to 1990, expenditures for clinical R&D in medical schools increased moderately. The average in-

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crease was about 13 percent per year. An estimate of the amount of support for clinical R&D in medical schools is needed to refine the model of demand for clinical faculty. An estimate of clinical R& D expenditures in medical schools was derived by using the proportion of total NIH obligations used to support clinical research. From 1969 to 1989 this proportion increased by 60 percent (Appendix Table F-22). Since 1980 public medical schools have had higher levels of research expenditures than have private schools. This is partly due to the fast growth in the number of public schools. Clinical R&D in public schools grew at an annual rate of 7 percent since 1980 as compared with only about 4 percent per year in private schools. However, private schools remain more research intensive as indicated by research expenditures per school. Average clinical R&D expenditures were $14.6 million in private schools in 1990 compared with $10.2 million in public schools (Appendix Table F-24). Professional Service Income Service income generated by medical school faculty has continued to grow. From 1989 to 1990 service income generated by medical school faculty grew 14 percent and from 1990 to 1991 this income grew 13 percent (figures adjusted for inflation in 1987 dollars). This has increased as medical schools have become very successful in providing clinical care. Thus, medical schools have come to depend on the clinical income to support their research and educational missions. Total Medical School Revenue Service income and federal research funds contributed over half of all medical school revenues in 1991. Another large portion came from state and local government sources. Tuition contributed only about 4 percent in 1991. With an average yearly tuition increase since 1985 of about 6 percent, medical student indebtedness, as noted by several testifiers at the public hearing, may operate as a deterrent to their pursuit of research training. The rates of total revenues have grown at an average yearly rate of 14 percent since 1986. Budgeted Faculty Vacancies Total budgeted medical school faculty vacancies have grown at an average yearly rate of about 6 percent since 1989. The major growth of vacancies is in the clinical science departments. There has been a steady decrease of faculty vacancies in the basic science departments with a high of 801 budgeted vacancies in 1985 to the 1991 low of 643 vacancies. Faculty/Student Ratio Enrollments, revenue, and clinical faculty size are the basic elements in assessing personnel needs for the clinical sciences in medical schools. The ratio of clinical faculty to enrollment is largely determined by the funds available to support faculty. Priority Fields Clinical investigation requires practitioners to stay abreast of developments in both medicine and science, each of which is in constant acceleration and often the two do not track in parallel directions (Fredrickson, 1993). Observations from the study of patients lead to the development of hypotheses, which lead, in turn, to scientific experimentation. Interest in the patient is always paramount, but scientific experimentation runs the risk today of taking the clinical investigator away from the bedside to the clinical laboratory. Ahrens (1992), in particular, has decried the reductionist direction of clinical investigation, suggesting that patient-oriented research is seriously imperiled. We concur with Ahrens view that more emphasis should be placed on the preparation of investigators familiar with the experimental paradigms associated with patient-oriented research. At the same time we recognize that laboratorybased clinical investigation has a significant and continuing role in the national health effort. However, from our review of the literature, and on the basis of our expert judgement, we cannot help but conclude that there is indeed a dearth of individuals adequately trained to perform patient-oriented or population-based research. With the development of new therapies and diagnostic procedures, there is an urgent need to train individuals who can carry these advances into the clinic so that their effectiveness can be measured and made available to the nation. NRSA funds, either through individual NRSA fellowships or programmatic training grants, can play an effective role in promoting the specialists that are needed. The MSTP also represents a priority field. Established in the 1960s, this program has been especially attentive to the essential training requirements for clinical investigation. A 1992 study of graduates of the Johns Hopkins University's M.D./Ph.D. program found that all of those who had completed their training were actively involved in research: 81 percent in academia, 14 percent at research institutes, and 5 percent in the biotechnology industry (McClellan and Talalay, 1992. See also Bradford et al., 1986 and Frieden and Fox, 1991). NIH has also analyzed information about first-time applicants for research grants (R01) and prior research train-

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ing experience (Appendix Table F-25). They found that in 1989 nearly 60 percent of individuals holding joint M.D./ Ph.D. degrees and applying for research support had received formal research training through support provided by NIH; this value was 47 percent for Ph.D. applicants and 42 percent for M.D. applicants. Furthermore, among firsttime NIH grant recipients in 1989, 68 percent of the M.D./ Ph.D. recipients had had previous NIH supported research training experience compared with 55 percent of the grant recipients holding Ph.D. degrees and 52 percent of those holding M.D. degrees (Appendix Table F-26). We conclude that continued and expanded support of the MSTP program will yield the cadre of active and successful physician-scientists so sorely needed for the national research effort today. ENSURING THE DIVERSITY OF HUMAN RESOURCES Issues remain regarding the recruitment of minorities to faculty and the retention of all M.D. investigators regardless of ethnicity and gender. In addition to improved recruitment, there must be specific attention given to the retention of women as clinical investigators and faculty. Extending the tenure clock and having on-site day-care are two examples of ways to facilitate their retention. Race and Ethnicity Medical school faculty reveal a race/ethnicity mix similar to the basic biomedical sciences (AAMC, 1992). Be TABLE 5-1 Distribution of U.S. Medical School Faculty by Rank and Ethnicity   Professor Associate Professor Assistant Professor Instructor Ethnicity Number % Number % Number % Number % Native American 24 0.1 13 0.1 22 0.1 11 0.2 Asian 1,065 5.7 1,334 7.9 2,300 8.6 590 904 Black 193 1 319 1.9 778 2.9 300 408 Mexican American 28 0.1 41 0.2 114 0.4 19 0.3 Puerto Rican 96 0.5 146 0.9 247 0.9 88 104 Other Hispanic 258 1.4 255 1.5 461 107 129 201 White 16,396 87.6 14,008 82.5 20,838 7705 4,512 72 Refused a 446 2.4 531 3.1 843 301 156 2.5 Missing 215 1.1 334 2 1,293 408 465 704 Total 18,721 100 16,981 100 26,896 100 6,270 100 a Declined to respond. SOURCE: Association of American Medical Colleges (1992). cause most of the U.S. population will soon be a mixture of races other than white, the market will demand a more widely representative pool of researchers. About 13 percent of the faculty are members of minority groups and the largest share of these workers is Asian (Table 5-1). Table 5-1 displays the medical school faculty by rank and ethnicity: of the professors, 87.6 percent are white, 5.7 percent are Asian, and 2.4 percent declined to respond; of the associate professors, 82.5 percent are white, 7.9 percent are Asian, and 3.1 percent declined to respond; of the assistant professors, 77.5 percent are white and 8.6 percent are Asian, and information was missing on 4.8 percent; of the instructors, 72 percent are white and 9.4 percent are Asian, and information was missing on 7.4 percent. Although 13 percent of the entire faculty represent minorities, this mix is generally not yet reflected in higher faculty ranks. Age Figure 5-1 shows the distribution of U.S. medical school faculty by age. Out of a total of 70,187 faculty, 57.6 percent are ages 40-49 and 25 percent are ages 30-39. Table 5-2 indicates that of those aged 40-49, 22.4 percent are full professors, 55.3 percent are associate professors, 39.1 percent are assistant professors, and 29.9 percent are instructors. Of those aged 30-39, 0.3 percent are professors, 8.1 percent are associate professors, 45.8 percent are assistant professors, and 51.8 percent are instructors. Of the M.D./ Ph.D. graduates, 39.8 percent are ages 40-49 and 25 percent are ages 50-59 (Table 5-3). Only 15.6 percent M.D./Ph.D. graduates are ages 30-39.

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FIGURE 5-1 Distribution of U.S. medical school faculty by age. SOURCE: Association of American Medical Colleges (1992). TABLE 5-2 Distribution of U.S. Medical School Faculty by Degree and Age   Professor Associate Professor Assistant Professor Instructor Age Number % Number % Number % Number % Under 30 0 0 0 0 58 0.2 102 1.6 30-39 62 0.3 1375 801 12314 45.8 3248 51.8 40-49 4185 22.4 9397 55.3 10512 39.1 1875 29.9 50-59 7835 41.9 4265 25.1 2286 8.5 533 8.5 60-69 5526 29.5 1532 9 790 2.9 168 2.7 70+ 1038 5.5 220 1.3 129 0.5 25 0.4 Missing 75 0.4 192 1.1 807 3 319 5.1 Total 18721 100 16981 100 26896 100 6270 100 SOURCE: Association of American Medical Colleges (1992). TABLE 5-3 Distribution of U.S. Medical School Faculty by Rank and Age   M.D. Ph.D./O.H.D. a M.D.-Ph.D./M.D.-O.H.D. a Other b Age Number % Number % Number % Number % Under 30 60 0.1 58 0.3 1 0 96 2.1 30-39 12114 28.3 3715 19.7 600 15.6 1092 23.6 40-49 15235 35.6 7976 4202 1529 39.8 1625 35.2 50-59 8786 20.5 4652 24.6 960 25 693 15 60-69 5203 12.1 1995 10.6 586 15.3 298 6.4 70+ 971 2.3 268 1.4 131 3.4 50 1.1 Missing 456 101 237 1.3 31 0.8 769 16.6 Total 42825 100 18901 100 3838 100 4623 100 a O.H.D.: Other health doctorate. b Other: Faculty with non-doctoral/no degree or missing degree data. SOURCE: Association of American Medical Colleges (1992). THE NRSA PROGRAM IN THE CLINICAL SCIENCES Every NRC study committee has noted that recruitment of qualified clinical researchers poses special challenges. Physicians, dentists, and veterinarians enjoy several attractive career alternatives. The vast bulk of Ph.D. trainees pursue research careers, but only one-third of postdoctoral M.D. trainees have followed that path, with most entering medical practice instead. Part of the reason is that preparing clinical specialists for practice in shortage fields has been an explicit purpose of the NIH funding programs. With that goal now substantially met, however, the committee doubted the need for continued subsidy to clinical training for practice.

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In its first report in 1975, the committee found the available data on clinical researchers to be wholly inadequate to its needs, and it declined to recommend any change in existing levels of funding: 140 predoctoral and 3,340 postdoctoral clinical sciences trainees. Beginning with the 1976 report, the committee began to grapple in earnest with the scope of its task. On the basis of unique value and the special demands of clinical research and the fact that professional schools do not ordinarily prepare students for careers as researchers, the committee concluded that postdoctoral clinical trainees should generally receive their support in the form of training grants made to professional schools, which permit these institutions to build in a short time the critical mass of students and web of resources necessary for high-quality programs. Evidence available in the early 1970s suggested that, unlike the burgeoning supply of Ph.D. researchers, the pool of M.D. investigators was shrinking while demand was growing steadily. Despite 6 percent annual growth in medical school faculties, the American Medical Association figures showed a significant drop since 1968 in the number of physicians engaged primarily in research. Therefore, the committee recommended funding a total of 2,800 postdoctoral traineeships and fellowships, up 10 percent from the number funded in 1975. It also praised the MSTP, initiated in fiscal year 1964, which supported students in combined 6-year M.D./Ph.D. courses. The committee recommended funding 600 MSTP traineeships, up 19 from the 581 funded in 1975. With the next several reports beginning in 1977, the committee began exploring why the number of physicians-scientists was dropping. Although both enrollment and R&D funding were rising rapidly at medical schools, many established clinical faculty members were spending relatively little of their time conducting research. In response to this finding, the committee detailed a number of factors that it believed might discourage physicians from undertaking research careers: the risk of failing at an untried field after demonstrating the ability to succeed in medical practice, the loss of income as compared to practice, a growing perception among students that patient care has greater value than research, social pressure on students to enter primary care fields, and an image that paperwork and red tape inhibit researchers more than in the past. In addition, the committee noted a discrepancy between the medical training calendar and the NIH grant cycle. Physicians who were planning for residencies to begin in July had to do so as early as the preceding October, many months before NIH announced its training awards. In view of these circumstances, the committee continued through the 1970s to recommend 2,800 postdoctoral traineeships and fellowships in clinical sciences. It also continued to praise the MSTP awards as a highly effective method of producing clinical researchers, recommending incremental increases in the program. By 1979 the committee's warnings appeared to have had an effect. Presidents of four leading societies discussed the threat of clinical investigator shortage in major addresses, as did a conference at the University of Chicago. Various agencies had already begun trying to counter the shortage. NIH, for example, had expended and modified its grant mechanism to ease the transition from medical school to research training and then to independent research. A 1978 amendment to the NRSA Act encouraged students to do short-term research under 3-month grants not subject to payback. Several other developments that pointed toward a brighter outlook were an increase in the number of physicians reporting research as a major activity, an increase in the number of clinical science traineeships and fellowships, and survey results showing that medical students were growing more interested in research. The committee maintained its recommendation of 2,800 postdoctoral awards. During the early 1980s the committee continued to recommend holding the number of awards stable at 2,800. Market opportunities for clinical investigators continued to be favorable, with medical school faculties still growing and providing places for young scientists interested in research careers. The immediate problem was the recruitment of physicians to undertake research training. The committee was concerned about a looming physician surplus, which would probably slow the growth of medical school enrollments and faculty and in turn reduce the positions available to new clinical researchers. Even with fewer openings, however, the committee believed that clinical investigator posts would remain hard to fill. In 1985 the committee recommended a rise in the number of NRSA awards. It believed that demand would grow faster than expected, in part because of increasing attrition from an aging faculty pool. The 1985 report also highlighted some important changes in medical school financing that the committee feared might further weaken clinical departments' commitment to research. As revenue from patient care steadily climbed, the committee believed that clinical faculty might find these demands competing for the time needed to prepare proposals, collect data, write grants, and so forth. In addition, as faculties grow less rapidly, medical school might favor hiring clinician-teachers over physician-scientists. The committee also examined factors affecting young dentists' decision to pursue careers in clinical research. Although, unlike physicians, dentists have ample opportuni-

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TABLE 5-4 Aggregated Numbers of NRSA Supported Trainees in the Medical Scientist Training Program (MSTP) for FY 1991 through FY 1993. Fiscal Year Number of Predoctoral Trainees 1991 783 1992 806 1993 822 NOTE: Based on estimates provided by the National Institutes of Health. See Summary Table 1. ties for research during postdoctoral specialty training, only a few trainees receive salaries and some must even pay tuition. The committee recommended special consideration to providing adequate support for training dentist-researchers. In 1989 the committee noted that the number of NIH traineeships and fellowships for clinical investigators (whom it chose to call physician/scientists) had not increased as fast as health-related R&D expenditures. The percentage of M.D.s who were principal investigators on NIH research grants had fallen, although the number of M.D./Ph.D. principal investigators had remained constant for the past decade. The committee speculated that the demand for physician-scientists would increase in the future as health-related R&D increased. However, given the lack of compelling data about supply and demand and questions about the effectiveness of physician research training, the committee recommended that the number of training positions remain the same until current training programs could be evaluated. RECOMMENDATIONS The following recommendations are made to enhance our excellence in physician-based research. The Medical Scientist Training Program In 1963, NIH granted funds to three institutions to support just under 20 individuals who pursued the M.D. and TABLE 5-5 Committee Recommendations for Predoctoral Traineeships in the Medical Scientist Training Program for FY 1994 through FY 1999. Fiscal Year Number of Predoctoral Trainees 1994 890 1995 955 1996 1,020 1997 1,020 1998 1,020 1999 1,020 Ph.D. degrees concurrently. Early NRC study committees reported findings from studies that consistently showed that a substantial fraction of MSTP awardees remain productively engaged in research, often with greater success in securing research support than M.D.s who pursue post-M.D. research training not leading to a doctorate. Current support for M.D./Ph.D. training provides for about 820 awards (Table 5-4). Given the success of this program in contributing workers to the national research effort and the continuing and increasingly difficult problem of attracting M.D.s without Ph.D. training to research careers, we believe this program should be expanded significantly in the coming years (Table 5-5). RECOMMENDATION: To meet the nation's continuing need for clinical investigators, the committee recommends that the number of NRSA trainees supported through the MSTP program be increased from 822 in 1993 to 1,020 trainees each year by the year 1996. Individual Fellowships Because of the urgent need for clinical scientists familiar with patient-based research techniques, we urge NIH to increase the number of postdoctoral NRSA fellowship awards to permit the preparation of patient-based investigators. RECOMMENDATION: The committee recommends that NIH increase support for individuals to train in patient-based research by increasing the number of

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TABLE 5-6 Aggregated Numbers of NRSA Supported Trainees and Fellows in Clinical Sciences for FY 1991 through FY 1993       Type of Support Fiscal Year Level of Training TOTAL Traineeship Fellowship 1991 Number of awards 2,894 2,814 80   Predoctoral 755 736 19   Postdoctoral 2,139 2,078 61 1992 Number of awards 2,970 2,887 83   Predoctoral 819 800 19   Postdoctoral 2,151 2,087 64 1993 Number of awards 2,974 2,877 97   Predoctoral 855 826 29   Postdoctoral 2,119 2,051 68 NOTE: Based on estimates provided by the National Institutes of Health. See Summary Table 1. postdoctoral fellowships in the clinical sciences from 68 in fiscal from 68 in fiscal 1993 to 160 by fiscal 1996. Institutional Training Grants in the Clinical Sciences To permit the expansion of the pool of MSTP trainees and postdoctoral clinical science fellows, we believe modest reductions should be made in the number of postdoctoral awards made through institutional training grants. NIH reports that 2,087 awardees were supported in fiscal 1992 through this mechanism (Table 5-6). We believe a gradual decrease should occur in the number of awards (Table 5-7). This would be done to permit the expansion of the MSTP program (described above). RECOMMENDATION: The committee recommends that the number of postdoctoral institutional traineeships supported through the NRSA program in the clinical sciences be slightly decreased from 2,051 to 1,965 between 1993 and 1996. NOTES 1. Several studies, it must be added, have identified a lack of rigorously trained individuals who know how to perform patient-based research (e.g., Ahrens, 1992) as a special need at this time. 2. The clinical sciences are understood to include individuals holding degrees in a variety of health professions including: medicine, veterinary sciences, dentistry, nursing, clinical psychology, and social work. The research training needs of clinical psychologists have been addressed in chapter 4 of this report (“Behavioral Sciences”), dentistry needs are separately addressed in chapter 6 (“Oral Health Research”), and nursing addressed in chapter 7 (“Nursing Research”). The committee did not address research training needs in the veterinary sciences or social work, but recognizes that these fields contribute to the national research effort and merit support through the NRSA program. 3. A recent report of the Institute of Medicine, Careers in Research: Obstacles and Opportunities (1994) investigates ways to improve the quality of training for clinical investigators and delineates pathways for individuals pursuing careers in clinical investigation in nursing, dentistry, medicine and other health professions engaged in human research. REFERENCES Ahrens, E. H., Jr. 1992 The Crisis in Clinical Research: Overcoming Institutional Obstacles. New York: Oxford University Press. Association of American Medical Colleges (AAMC) 1992 U.S. Medical School Faculty: 1992. Washington, D.C.: Association of American Medical Colleges. Bradford, W.D., S. Pizzo, and A.C. Christakos 1986 Careers and professional activities of graduates of a Medical Scientist Training Program. Journal of Medical Education. 61: 915-918. Fredrickson, D.S. 1993 Clinical Investigation. Paper prepared for the Committee on National Needs for Biomedical and Research Personnel. Frieden, C. and B.J. Fox 1991 Career choices of graduates from Washington University's Medical Scientist Training Program. Academic Medicine. 66: 162-164. Institute of Medicine (IOM) 1994 Careers in Clinical Research: Obstacles and Opportunities. Washington, D.C.: National Academy Press. McClellan, D.A. and P. Talalay 1992 M.D.-Ph.D. training at the Johns Hopkins University School of Medicine, 1962-1991. Academic Medicine. 67(1): 36-41. National Research Council (NRC) 1975 Personnel Needs and Training for Biomedical and Behavioral Research. Washington, D.C.: National Academy Press. 1978 Personnel Needs and Training for Biomedical and Behavioral Research. Washington, D.C.: National Academy Press. 1985 Personnel Needs and Training for Biomedical and Behavioral Research. Washington, D.C.: National Academy Press. 1989 Biomedical and Behavioral Research Scientists: Their Training and Supply, Volume I: Findings. Washington, D.C.: National Academy Press.

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TABLE 5-7 Committee Recommendations for Relative Distribution of Predoctoral and Postdoctoral Traineeship and Fellowship Awards in Clinical Sciences for FY 1994 through FY 1999       Type of Support Fiscal Year Level of Training TOTAL Traineeship Fellowship 1994 Recommended number of awards 2,975 2,875 100   Predoctoral 895 875 20   Postdoctoral 2,080 2,000 80 1995 Recommended number of awards 2,910 2,780 130   Predoctoral 895 875 20   Postdoctoral 2,015 1,905 110 1996 Recommended number of awards 2,860 2,680 180   Predoctoral 895 875 20   Postdoctoral 1,965 1,805 160 1997 Recommended number of awards 2,860 2,680 180   Predoctoral 895 875 20   Postdoctoral 1,965 1,805 160 1998 Recommended number of awards 2,860 2,680 180   Predoctoral 895 875 20   Postdoctoral 1,965 1,805 160 1999 Recommended number of awards 2,860 2,680 180   Predoctoral 895 875 20   Postdoctoral 1,965 1,805 160