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Gail H. Cassell is chair of the ASM Public and Scientific Affairs Board. This article is based on her testimony at the Senate Committee on Labor and Human Resources hearing on NIH reauthorization on 7 May 1996.
As forces converge to shape and change the delivery of health care in the United States, we expect a dramatic effect on research training of not only physicians but also basic scientists. The potential flattening of reimbursement of clinical care will curtail clinical income that, in many medical schools and academic health centers, subsidizes the support for research training of physicians.
At the same time that changes in health care are impacting monies available for clinical research and training, most state-supported institutions have had their overall state support reduced significantly over the past several years, with future funding projected to be flat at best. Likewise, sources of private funding have also declined. This comes at a time when the research opportunities have never been greater and when the time to degree has never been longer.
There are several factors which compromise the environment for research trainees: a lack of university funds to purchase major equipment, a lack of institutional funds for shared core facilities, and a decline in the overall infrastructure for animal research. Perhaps the last provides the best example of a decline in research infrastructure.
At present, over 50% of NIH funded grants use vertebrate animals. All indications are that with continued advances in genomics, animal use will continue to increase. The enormous investment in organismal research, fueled by the exploding use of genetically altered and immunodeficient animals, must be protected. NIH historically has been responsible for supporting the infrastructure for protecting this investment.
Federally mandated changes in indirect-cost allowances for animal facility operations, increasing costs due to the complexity of the animal models being used, the loss of animal resource program support formerly provided by the NIH National Center for Research Resources, flat or reduced funding from university sources, and increasing federal regulations governing animal use in biomedical research are now converging to erode the animal resource infrastructure at most research institutions in this country. Ironically, federal and local support for diagnostic services and for research and development on diagnostic strategies for intercurrent diseases in laboratory animals has virtually disappeared at a time when populations of highly susceptible animals (e.g., transgenic, gene knockout, and immunodeficient animals) are increasing.
Individuals well trained in laboratory animal medicine (clinician scientists) are essential to ensure the highest quality of laboratory animal care as well as to achieve the maximum benefit from animal research. Such specialists must be academically oriented to provide maximum leverage for investments in salary and training. These specialists are trained almost exclusively in biomedical research institutions. However, training funds cannot come from clinical revenues as is often the case in physician training, since such funds would have to be obtained largely through per them charges for animal care. In the past, NIH has had a key role in providing this training, but many of these programs are being phased out because of tight resources, leaving the source of future clinician-scientists in doubt.
Most importantly, the training environment is being threatened by lack of time for faculty to mentor trainees, because of increased clinical responsibilities of physician mentors and increased time spent in seeking grant funding by both clinical and basic science mentors.
To best take advantage of research opportunities and to ensure rapid and efficient translational research, workforce planning must reflect the respective roles played M.D.'s, M.D.-Ph.D.'s, D.M.D., Ph.D.'s, Ph.D.'s, D.V.M.'s, and other health-care professionals. More data are needed to determine the most efficient training methods.
Recent data obtained by the Office of Information Resources of the Association of American Medical Colleges (AAMC) in collaboration with NIH suggest that individuals with the dual M.D.-Ph.D. degree are more likely to submit grants aligned more closely with the laboratory pursuits of most of their Ph.D. counterparts than with the more clinically oriented endeavors of those with the M.D. alone. The traditional view has been that the dual M.D.-Ph.D. training program of NIH should be expanded to ensure sufficient numbers of clinical investigators.
In truth, the data do not exist to make an accurate assessment of the number of patient-oriented clinical investigators or the number being trained. Some means must be developed for determining what programs are, in fact, training patient-oriented clinical investigators. Once these programs are identified and suitable outcome measures are determined, the most effective programs should be expanded.
Recent data indicate that undergraduate medical students supported by NIH T35 grants (short term training grants for M.D.'s, D.M.D.'s, and D.V.M.'s) are more likely to seek academic careers and are more likely to be successful in securing research funding than those who do not participate in formal research training. Perhaps this mechanism should be expanded.
Few programs rigorously give clinical scientists a substantive foundation in clinical research methods. Consideration should be given to establishment of formal training programs in clinical research which take advantage of the uniqueness of the clinical center within the intramural program at NIH and the general clinical research centers within academic health centers. Training programs should provide formal courses in epidemiology, biostatistics, design of clinical trials, and ethical considerations in performing research in humans.
Increased emphasis on the maintenance of health, the outcome and quality of care, and the assessment of the impact of technology provides unique opportunities for prevention and health services research. Yet few physicians and other health-care professions have specific training in these areas. Thus, formal training programs in these areas must be established.
To facilitate application of basic research to clinical practice, it is also important for basic scientists to learn principles of performing high-quality clinical research. To add balance to interdisciplinary research teams, more efforts should be made to recruit D.V.M.'s. Development of animal models is an area of increasing importance. Furthermore, as already mentioned, quality laboratory animal facilities with high-quality disease-monitoring capabilities are essential. Trainees at all levels thus need to be taught sound principles of animal experimentation.
Much has been said recently concerning fears that American universities may be producing more Ph.D.'s than can be meaningfully employed in the scientific enterprise. These statements often are based on perception, not data. A recent ASM survey indicates a positive outlook for the need of Ph.D.'s in the microbiological and immunological sciences in industry and education with limited need in the clinical-medical sector in specific subdisciplines. The survey illustrates the dangers in reducing cross-disciplinary Ph.D. training without supporting data and also emphasizes the need to restructure training programs to take into consideration the needs of future employers.
Reapportionment of research and development funding between academia and industry has had and will continue to have an important impact upon research funding and research training. With the growing interrelationships between industry and academia, old paradigms of collaboration are being reinforced or remodeled and new ones are being shaped. Consideration should be given to training programs jointly funded by academia, NIH, and industry.
NIH Training Role
The intramural research program (IRP) on the NIH campus is vital for this country's research enterprise not only within the extramural community but also within the IRP. At least 50,000 scientists have trained at NIH. Upon leaving NIH, they not only have made valuable contributions in academic institutions but also have played a critical role in the success of the biotechnology industry in the United States. With pending changes in health-care reimbursements, the role of the IRP in training the physician scientist may become even more important.
Extramural and intramural NIH-sponsored training programs are critical to the overall quality and future success of this nation's research enterprise. Therefore, NIH training programs must be a high priority. Reversal of the current trend requires stable funding for competitive trainee stipends, a strong research infrastructure, and a strong national commitment to biomedical research.