Appendix A
Report of the Task Force on Clinical Research in Dentistry

EXECUTIVE SUMMARY

Energized by the highly successful national investment in biomedical and behavioral research, the discipline of clinical research has undergone a remarkable evolution in the scope, sophistication, and power of its methodologies. Development of clinical research is expected to accelerate in the future, driven by the explosion of science in biotechnology, molecular biology, computer technology, diagnostic systems, decision analysis, and clinical measurements technology. The task force supports the conclusion that there is an overall need to expand the pool of biomedical clinical investigators and the monies available for clinical research. Its specific charge was to focus on the unique barriers and, particularly, the unique opportunities in oral health research that warrant specific attention and remedies.

Past successes of clinical research in dentistry underscore the need for continued clinical dental research to take full advantage of opportunities for transfer of fundamental information to patients. No example is more dramatic than the significant reduction in dental caries and corresponding improvements in the oral health of school-age children and young adults that is estimated to have saved over $39 billion, in 1990 dollars, from 1979 through 1989. The application of basic science research findings to dental practice as a result of clinical research has also saved the American public from much suffering and lost productive time.

This change in the oral disease pattern has triggered a marked change in the dental profession, with a shift of focus to diseases that were formerly ignored.



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Careers in Clinical Research: Obstacles and Opportunities Appendix A Report of the Task Force on Clinical Research in Dentistry EXECUTIVE SUMMARY Energized by the highly successful national investment in biomedical and behavioral research, the discipline of clinical research has undergone a remarkable evolution in the scope, sophistication, and power of its methodologies. Development of clinical research is expected to accelerate in the future, driven by the explosion of science in biotechnology, molecular biology, computer technology, diagnostic systems, decision analysis, and clinical measurements technology. The task force supports the conclusion that there is an overall need to expand the pool of biomedical clinical investigators and the monies available for clinical research. Its specific charge was to focus on the unique barriers and, particularly, the unique opportunities in oral health research that warrant specific attention and remedies. Past successes of clinical research in dentistry underscore the need for continued clinical dental research to take full advantage of opportunities for transfer of fundamental information to patients. No example is more dramatic than the significant reduction in dental caries and corresponding improvements in the oral health of school-age children and young adults that is estimated to have saved over $39 billion, in 1990 dollars, from 1979 through 1989. The application of basic science research findings to dental practice as a result of clinical research has also saved the American public from much suffering and lost productive time. This change in the oral disease pattern has triggered a marked change in the dental profession, with a shift of focus to diseases that were formerly ignored.

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Careers in Clinical Research: Obstacles and Opportunities Most notable of these are the periodontal diseases, affecting some 7 out of 10 adults, which are responsible for much of the tooth loss in adults, and are now replacing caries as the most prevalent infection in humans. Other oral diseases include oral cancer; salivary dysfunction; oral mucous membrane lesions such as aphthous ulcers; oral herpes; oral diseases in patients with systemic diseases, such as periodontal disease in diabetics; and oral candidiasis and necrotic periodontal lesions in AIDS patients. There are many opportunities for improving the general health of humankind from expanded clinical research in oral health. In view of the opportunities for application of knowledge and technologies to manage and prevent oral diseases and their sequelae, specific barriers and opportunities for clinical research were examined. The product of the task force's assessment was a series of recommendations that can be summarized as follows: Increase the funding for population-based clinical studies and technology transfer. Educate dental scientists to existing resources that can be used in clinical dental research. Improve the peer review structure for clinical dental research proposals. Address the shortage in human resources needed to accomplish dental clinical research objectives by developing an essentially new type of investigator, the senior dental clinical scientist; improving the clinical research competencies of both seasoned and young dentist-scientists with basic science training; and capitalizing on the capabilities of existing dental clinical faculty through the implementation of an innovative short-term training program for dental clinical research associates. Address important structural barriers existing in many dental schools that limit their clinical research capabilities and facilitate the transition of these institutions into viable and productive members of the academic health centers. To accomplish many of these recommendations, the task force would ideally prefer the provision of new or augmented resources. At the same time, cognizant of not only the financial constraints presently faced by government, industry, and the educational sectors but also the oral health benefits that would follow an expansion of dental clinical research, the task force endorses the refocusing of existing resources to significantly expand national dental clinical research capabilities. The critical issue(s) or problem(s) in each area was identified, together with specific recommendations. These recommendations have a reasonable chance of success—most can be carried out almost immediately—and they have measurable endpoints.

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Careers in Clinical Research: Obstacles and Opportunities CLINICAL RESEARCH IN DENTISTRY There is an acute need for focused, high-quality clinical dental research. A relatively small investment in clinical dental research can have a large impact, improving both oral and general health. Over the past several decades there have been remarkable improvements in the oral health of the U.S. population that have been made possible, to a great extent, by clinical research advances in dentistry. Among these advances are such notable examples as the fluoridation of public water supplies, which has resulted in a marked decrease in the incidence of dental caries, and the development of improved dental materials such as composite resins and dental sealants. There are a number of additional areas in which there is a sufficient base of laboratory investigation for the initiation of clinical trials. The main barrier to this transfer of technology is the lack of resources for clinical investigation in dentistry. Background Clinical research in dentistry encompasses a number of different areas focusing on the human oral cavity. Epidemiologic studies determine oral health care needs in the United States regarding dental caries and periodontal disease, which are the traditional foci of dental clinical investigations. Other areas that could benefit from clinical research include salivary function, oral cancer, taste and smell, craniofacial anomalies and acquired defects (for example, trauma), temporomandibular joint disorders, nutritional deficiencies affecting the oral cavity, and the oral sequelae of systemic diseases such as diabetes mellitus and human immunodeficiency virus (HIV) infection. On the basis of the perceived oral health care needs of the U.S. population, clinical studies in dentistry examine the etiologies of these oral diseases and encompass such basic science disciplines as microbiology, immunology, and biochemistry, and clinical sciences including radiology. Determination of the etiology of the various oral diseases consequently leads to a major focus on research in clinical intervention. This research includes clinical trials comparing treatment regimens; product testing, such as that required for dental materials; local antimicrobial and antiplaque agents; and studies of health care delivery. Behavioral science studies in clinical dental research examine issues such as patient compliance, utilization of specific self-care or provider-based prevention or treatment intervention, and health promotion. Furthermore, utilizing the oral cavity as a ''window to the body," clinical dental research offers a model with broad applicability to biomedical research in such areas as pain control, mucosal immunity, and the pathobiology of secretions and secretory glands.

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Careers in Clinical Research: Obstacles and Opportunities Although clinical dental research activities encompass a relatively broad spectrum of areas currently being examined by a small number of appropriately trained clinical investigators, the explosion of basic research applicable to clinical dentistry sets the stage for unprecedented opportunities for the clinical research needed to accelerate appropriate technology transfer. This is likely to have a major impact on oral health in the United States and throughout the world. Advances in anti-infective therapy for periodontitis; in the clinical, radiographic, and laboratory diagnoses of oral disease; in the remineralization of carious lesions; and in the regeneration of oral tissues destroyed as a result of chronic infection are but a few of the areas ripe for clinical application. Furthermore, there have been major advances in the science of clinical dental research itself, with significant improvements in data collection instruments and statistical analysis of hypothesis-oriented clinical problems. Future advances in areas such as molecular epidemiology will find ready application in clinical dental studies. In addition to a backlog of basic science developments that need immediate clinical testing, a number of other conditions or factors will require increased clinical dental research efforts. Prime among these, as for biomedical science in general, is the desire for increased knowledge in order to diagnose and treat oral diseases. The growing regulatory requirements from the Food and Drug Administration (FDA) and other agencies that must be fulfilled prior to the marketing of dental products also will increase the need for clinical research. The primary source of support for oral health research is the National Institute of Dental Research (NIDR). For this reason, the task force was particularly interested in assessing the current NIDR funding for dental clinical research. Preliminary results from a recent general assessment indicate that approximately one-fifth of the NIDR extramural budget and one-fifth of the number of research grants supported by the NIDR in fiscal year 1991 involved clinical investigators to at least some extent. The task force and the NIDR leadership recognize that this may be an overestimate. In addition to the support from the National Institutes of Health (NIH), an unknown amount of support for clinical dental research is provided by industrial sources. With few exceptions, however, this research is restricted to narrow, product-oriented studies including randomized clinical trials and studies required by the FDA or other regulatory agencies and as defined by the sponsoring organizations. There is, however, anecdotal evidence of increasing industrial support from traditional industries and from new biotechnology companies for exploratory projects, some of which may lead to potentially commercial findings.

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Careers in Clinical Research: Obstacles and Opportunities Recommendations In order to expand clinical dental research, the task force recommends an increase in funding for population-based clinical studies and technology transfer. Clinical dental research often can be accomplished through NIDR-directed reallocation of existing resources through the request for application (RFA) mechanism. In addition, by allocating increases in the NIDR budget to clinical research and by better using existing resources—such as integrating clinical oral health studies with clinical general health studies and using clinical center grant mechanisms—clinical studies can be funded. For example, studies of the oral manifestations of systemic diseases such as diabetes mellitus and HIV infection can often be combined with a parent medical study, thus avoiding redundancy and affording better utilization of the general health database. The task force recommends that it will be necessary to educate clinical dental scientists about resources that can be used in clinical dental research. NIH supports a number of core facilities and repositories that are designed to serve as resources for clinical investigators. Prominent among these are the Clinical Research Centers, which can assist the clinical investigator in study design, data and material collection, and data analysis. In addition, private industry has made a large investment in science and technology. Methods and results from these activities have great relevance to clinical dental researchers. Information regarding the availability of these resources should be disseminated to clinical dental scientists. The task force recommends that improvements are needed in the structure and organization of peer review for clinical dental research proposals. Clinical dental research has emerged as a highly sophisticated and specialized field addressing major public health problems. The level of education and expertise necessary both to formulate and to review clinical dental research proposals is akin to that required in other highly specialized biomedical fields, such as molecular biology. Accordingly, the success of clinical dental research proposals may be enhanced by improving the quality of the research proposals. Modification of the structure or organization of peer review of population-based clinical research proposals by NIH—with the inclusion of more seasoned clinical investigators—would likely lead to more responsive and informed decisions. This may be accomplished by one or more of the following: the establishment of a separate study section dealing exclusively with clinical dental research proposals for investigator-initiated support, greater use of teleconferencing and site visits for the evaluation of clinical dental research proposals,

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Careers in Clinical Research: Obstacles and Opportunities greater attention to the selection of highly qualified and experienced clinical researchers to serve on study sections and more willingness on the part of clinical scientists to agree to participate on chartered study sections, and utilizing the RFA mechanism of NIDR to encourage high-quality, hypothesis-oriented, population-based research in oral conditions and diseases. HUMAN RESOURCES More well-trained, clinical investigators are needed in dental research. Background The task force defines a senior dental clinical scientists as one who plans, develops, coordinates, directs, and analyzes "patient-oriented or patient-related" clinical dental research. This scientist should ideally be a dentist or dental scientist with a full-time effort and a long-term commitment in clinical investigation. This individual should have training in a specific clinical specialty; a Ph.D. or comparable training in an area required for directing clinical investigations, such as epidemiology, biostatistics, or behavioral or social science, with additional training in clinical research methodology; and knowledge, either through training or experience, of cutting-edge laboratory methods from such fields as molecular and cellular biology, immunology, genetics, microbiology, and radiography that is sufficiently developed for application in patient-related research. These scientists should be able to answer fundamental questions in the clinical sciences through clinical trials, clinical studies of small populations, and epidemiologic investigations of small and large populations. In addition, they should be able to collaborate with practitioners in the transfer of relevant basic and clinical research to the patient care setting. There are few senior dental clinical scientists in dentistry today. The task force is convinced that special effort is warranted to train a cadre of such investigators to bring the energy, direction, and unique competency needed to move dental clinical research into the large, well-coordinated, multicenter research arena. Another group of scientists who can participate in clinical research are the dentist-scientists. Dentist-scientists presently exist in dental research, although in inadequate numbers. The preparation of dentist-scientists includes both a clinical specialty and extensive postdoctoral research training and, in most cases, a Ph.D. in a relevant basic science discipline. Such individuals usually begin their research careers in basic science. As their careers progress, some recognize the need or potential to expand their research into clinical settings. The dentist-scientists who make this transition most often have become self-educated in clinical research study design and methodology. Those fortunate enough to be

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Careers in Clinical Research: Obstacles and Opportunities located in research-intensive academic health centers frequently have developed productive alliances with epidemiologists, biostatisticians, and other clinical researchers who have helped them in the design and conduct of their clinical investigations. The increasing backlog of needed clinical studies mandates that such individuals should either have enhanced opportunities during their initial research training to develop clinical research competencies or should be able to take advantage of specially designed senior clinical research career development opportunities. The third category of clinical researcher the task force feels is needed is the dental clinical research associate. Within academic dentistry there is a large pool of dental clinical faculty who, although very limited in formal research training or experience, have superior clinical capabilities. Encouraged by the increasing pressure of the university for all faculty to be engaged in scholarly activity, many of these faculty would welcome the opportunity to actively assist in the conduct of clinical studies and trials. The availability of specially designed and highly focused short-term training would quickly build a cadre of clinicians capable of executing rigorous clinical research protocols. Such research plans would typically be developed by the senior dental clinical scientists or a dentist-scientist with special clinical research training. The ability of the dental research community to carry out the needed dental clinical research agenda is dependent on a cadre of such dental clinical research associates who would function as examiners, operators, or in other roles to assist in clinical research. To prepare for future clinical research activities in dentistry, the availability of human resources must be assured. Most urgently needed are appropriate expertise and skills to meet the expected need and demand for senior dental clinical scientists, dentist-scientists, and dental clinical research associates. This need exists in dental institutions, health science centers, private industry, and government facilities, including the FDA. A projection of the potential future need and demand for clinical researchers is provided in the section entitled Projecting the Potential Need for Clinical Researchers at the end of this appendix. A conservative estimate is that 42 senior dental clinicians and dentist-scientists and 84 dental clinical research associates are needed now, assuming the present level of funding for clinical research from NIDR. If federal funding levels and industrial support are increased for clinical research, these estimates may be very low. Recommendation The task force recommends the establishment of a well-defined clinical research training track to develop a cadre of

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Careers in Clinical Research: Obstacles and Opportunities senior dental clinical scientists. It is not sufficient to say that more clinical investigators are needed. What is needed is something that does not exist, or exists only in a few institutions, and that is a well-defined track, possibly leading to a graduate degree, that will train clinical investigators in all of the skills and concepts needed to carry out the full spectrum of clinical studies. Senior dental clinical scientists should be trained in (1) the ability to recognize significant clinical problems, for example, based on prevalence or impact of condition; (2) protocol design including the use of statistics for the appropriate application of such functions as power calculations and randomization and stratification methodologies; (3) implementation of the studies with detailed information on pretesting and pilot testing methodologies and assessment techniques; (4) monitoring the quality of the studies; (5) data collection, recording, management, and editing; (6) analysis of the data, including assessment of methodologic errors; and (7) data and report preparation and publication. They should also be able to design new experiments based on data interpretation and subsequent hypothesis generation. Current federally funded options for supporting the training of dental researchers include the Dentist-Scientist Award, Physician-Scientist Award, and the National Research Service Award. Although the development of clinical research skills is provided in some programs, none of these award mechanisms emphasizes the training of clinical investigators. For this reason, NIDR should be encouraged to develop a special research training program or to modify one of the existing training or career development programs to prepare senior dental clinical scientists. Industrial and foundation support for such training is limited but could be expanded to develop sufficient numbers of well-trained clinical researchers. The elements of training senior dental clinical scientists include academic and clinical epidemiology, research design and methods, biostatistics, clinical measurements, and clinical laboratory methodologies. Training in a clinical specialty or subspecialty may also be necessary for a fully trained, independent clinical investigator. Secondary elements in their training include ethics, conflict of interest, FDA regulatory issues, industrial issues, and commercialization such as patenting and licensing. Original thesis research involving a major representative clinical investigation would also be of importance. It is envisioned that this clinical investigator track would require full-time effort and a long-term commitment of possibly five to seven years, and that it would be comparable to a Ph.D. in basic science. It is likely that dental schools on health sciences campuses that also have a school of public health or strong departments of public health, preventive medicine, or comparable fields with Ph.D. programs in epidemiology and biostatistics can offer the opportunity for high-quality training in clinical research.

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Careers in Clinical Research: Obstacles and Opportunities The task force suggests the following strategies to increase the number of dentist-scientists with clinical research competencies: Require that essential clinical and epidemiologic research components be included in current Dentist-Scientist Awards or National Research Service Award postdoctoral research training and fellowship programs. Requests for applications for these training programs should request inclusion of specific training programs and experience in clinical research. Modify current or develop new clinical research career training opportunities for existing dentist-researchers who desire to move their research into clinical application. Provide short-term training opportunities for biostatisticians, epidemiologists, and scientists in other areas related to clinical research to facilitate the formation of dental clinical research teams. The following strategies would increase the number of dental clinical research associates. Establish short-term (two to four week), highly structured training in the execution of population-based clinical studies under the terms of a clinical protocol. Such training would include not only the technical aspects of a study but, more important, an understanding of the rigors of a clinical study and the requirements for strict adherence to protocol and proper data management and data analysis procedures. Work with the American Dental Association, FDA, and other regulatory agencies to develop guidelines for every large clinical studies and, most important, multicenter clinical trials to ensure the training, calibration, and continued quality control of dental clinical research associates who function as examiners or operators. BARRIERS TO THE DVELOPMENT AND SUPPORT OF CLINICAL INVESTIGATORS IN DENTISTRY The conduct of high-quality clinical research is hampered by several barriers to the development, support, and long-term retention of qualified and motivated clinical scientists. These barriers include inadequate fiscal resources, lack of adequately trained dental school faculty, constraints in the dental curriculum, and the culture of the dental school environment.

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Careers in Clinical Research: Obstacles and Opportunities Background The financial positions of most dental schools present special problems in the generation of discretionary funds that could be used to train fellows in clinical research, as frequently occurs in the hospital/medical school setting. Unlike medical education, which relies upon university or university-affiliated hospitals for clinical training, the dental school staffs, finances, and operates its own dental hospital. The cost of clinic operations, which are fundamental to the teaching program, are often borne entirely by the dental school. Unlike the teaching hospital, dental school clinics must offer care at 50 to 75 percent less than the customary fee as a patient incentive. Furthermore, dental schools frequently provide care without charge to the indigent and the uninsured. As a result, dental school clinics often operate at a financial loss. Some 150 million people in the United States do not have dental insurance. Furthermore, unlike the universal federal medical coverage of older Americans under Medicare, dental care is not covered. Indeed, there is limited and clearly inadequate coverage of dental treatment under the federal Medicaid program. In this regard, dentistry stands outside the broader health care system. This has resulted in dental schools, hospital-based graduate dental schools, and hospital-based graduate specialty programs that lack access to significant federal clinical service funding. These constraints significantly limit the ability of dental schools to support clinical research. There are few faculty members in dental schools adequately trained in the science of clinical research. As a result of the small number of qualified clinical researchers, few dental schools have active, state-of-the-art clinical research programs. The lack of role models may result in negative feedback that results in few faculty and students becoming committed to this career path. The availability of senior investigators who have made significant contributions through clinical research to serve as mentors may be required for the long-term development of a faculty oriented toward clinical research. In contrast to medicine, advanced dental education is generally not based on stipends, and many programs require tuition. On the basis of 1991 estimates, the average student leaves dental school with an indebtedness of $52,130, thereby limiting the possibilities of financing further training through personal resources. The NIDR training programs provide a mechanism to overcome this problem for a limited number of trainees. The often lockstep, four-year dental curriculum demands a major commitment of time from clinical faculty to train independent dental practitioners. Because dental schools must graduate competent clinicians, dental students cannot be mere observers but must be the active providers of care. Therefore, in addition to providing didactic education in the basic and clinical sciences, the dental school provides hands-on training in all aspects of clinical dentistry. With dental students performing mainly irreversible procedures on

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Careers in Clinical Research: Obstacles and Opportunities patients, the need for intensive, direct, and constant supervision by clinical faculty is clear. As a result, clinical researchers are not always recognized or compensated for participating in clinical research. One recognition would be commensurate release from clinical teaching responsibilities. Such release time is critical both to the successful conduct of the individual study and for maintaining an environment that rewards success in scholarly endeavors. The culture of U.S. dental schools also presents special problems in the development of an environment conductive to successful clinical research. Most of the mature dental faculty have the formal qualifications to practice general dentistry or a dental specialty; few, however, have training or experience in scholarly activity. Faculty background, training, and interest, coupled with the need to prepare students to be independent practitioners in a technically demanding discipline, have resulted in an understandable emphasis on clinical training and technique in four short years. Unfortunately, emphasis on the clinician as a scholar has suffered. Perhaps the most critical barrier to the development of mature, independent scientists in dentistry is that few dental schools provide an environment in which this development can easily occur. For example, there is often a lack of critical mass of scientists, mentors are not available, and resources needed in the early years of a scientist's career are often not allocated. Although more schools provide such an environment than was the case just 10 or 20 years ago, it still is difficult for the Ph.D. or D.D.S.-Ph.D. to succeed as a competitive, productive scientist without postdoctoral training and extended association with more mature scientists in the field. The clinical investigator is no exception. There are few schools where the environment is supportive of the young clinical investigator. The task force strongly believes that it is at this step in the training and maturation of a clinician-scientist (including the clinical scientist) that the dental academic system is most apt to fail. Recommendations The task force recommends that tenure-track appointments be reserved for faculty who participate fully in teaching, research, and service. Faculty devoted only to teaching or only to research may be placed on a fixed contract. Dental faculties and dental schools are in a time of transition from being institutions focused on technical training to becoming institutions that are true members of the university academic community. It is also recommended that institutions with minimal ongoing research recruit as department chairs successful midcareer clinical scholars who will be capable of building a research program and serving as role models and mentors. It is

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Careers in Clinical Research: Obstacles and Opportunities recognized that many dental schools want to increase their research enterprises. Newly trained individuals need the support of such an environment to be successful over the long-term. New clinical scientists (immediately after training) should not be appointed to positions where they do not have the time or the environment to be mentored and developed into independent investigators. The task force recommends that time and other resources such as space and start-up funds need to be made available to faculty undertaking clinical research. When research projects are extramurally supported, the salary released should be used to free investigators from their teaching load in keeping with the scope of the projects. These funds can then be used to expand the number of faculty and the research base of the department and institution. Over the long-term, means of restructuring the financing of preventive and therapeutic dental care and the financial structure of the dental education system should be explored. The task force recommends that mechanisms need to be established at each dental school to ensure that discretionary funded release time, overhead recovery, and salary release are used to provide support for innovative high-risk, start-up, or carry-over research activities. Measurement of Outcomes Long-term measures of the success of implementation of the task force recommendations include an estimate of the number of drugs, devices, and technologies that are made available to clinicians resulting in better treatment and more effective prevention of oral diseases in the years after implementation of the recommendations. More specific and near-term measures of success include more research funds devoted to clinical dental research by government and private industry, more clinical researchers engaged in population-based studies of oral disease, and more frequent and higher-quality publication of the results of clinical research projects. Projecting the Potential Need for Clinical Researchers It is difficult to project the potential need and demand for clinical researchers among private industry, the federal government, health science centers, and other such institutions. One can try to project possible needs, however, at least among U.S. dental institutions, which will be the most likely future employers of most of these individuals. The methodologic approach used to project personnel needs in the near future is based on approximations of the number of clinical research grants that

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Careers in Clinical Research: Obstacles and Opportunities could be funded through NIDR support and the number of clinical researchers (that is, senior dental clinical scientists, dentist-scientists, and dental clinical research associates) needed to direct and conduct these investigations. A conservative approach is based on a situation of no growth in the percentage of grant dollars awarded for clinical research by NIDR. The assumptions include the following: In fiscal year 1991, between 20 and 25 percent of NIDR extramural research support went to clinical research studies, and approximately 20 percent of NIDR extramural research funds for new and competing renewal applications supported clinical research projects. In the immediate future, it is assumed that the distribution of NIDR extramural support for clinical research will be about 20 percent. This does not imply, however, that this ratio should be perpetuated. The average cost of a clinical research grant may remain approximately $160,000. This is based on data for fiscal year 1991. (It is highly probable, however, that the average cost of these grants will increase substantially in the future.) Each senior dental clinical scientist and dentist-scientist could be involved, as a principal investigator, in no more than two active grants. (This is based on NIDR data which showed that, in fiscal year 1990, 80 principal investigators had two active NIDR research grants and 16 had three or more active awards.) One full-time dental clinical research associate is needed for each grant as a coprincipal investigator. Existing clinical researchers are working at maximum capacity. Therefore, the projected number of clinical researchers needed is assumed to be in addition to those already holding positions at dental institutions. (The actual number of the latter is unknown.) The projected number of research personnel needed by U.S. dental institutions—on the basis of current level of NIDR funding for clinical research and the assumptions listed above—are 42 well-trained senior dental clinical scientists and dentist-scientists and 84 dental clinical research associates. Changes in funding levels or in the set of assumptions will necessitate a revised estimate for needed clinical investigators. It should also be noted that these individuals would be in addition to those more oriented to the basic laboratory sciences who are already being trained through the dentist-scientist and physician-scientist award programs of NIDR. Further, and perhaps most important, this does not account for the clinical research personnel needs of private industry and nondental institutions in health science centers, hospitals, and the other employees of clinical dental researchers, which are not easily estimated but may be large and growing.

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Careers in Clinical Research: Obstacles and Opportunities TASK FORCE MEMBERS ROBERT J. GENCO, Chair, Associate Dean for Graduate Studies, Distinguished Professor and Chairman, Department of Oral Biology, School of Dental Medicine, State University of New York at Buffalo, Buffalo, New York JAMES W. BAWDEN, Alumni Distinguished Professor, Department of Pediatric Dentistry, School of Dentistry, University of North Carolina, Chapel Hill, North Carolina MARJORIE K. JEFFCOAT, Rosen Professor and Chairman, Department of Periodontics, School of Dentistry, University of Alabama, Birmingham, Alabama JAMES A. LIPTON, Special Assistant for Scientific Development, Epidemiology and Oral Disease Prevention Program, National Institute of Dental Research, National Institutes of Health, Bethesda, Maryland PRESTON A. LITTLETON, JR., Executive Director, American Association of Dental Schools, Washington, D.C. JOSEPH J. ZAMBON, Professor, Department of Oral Biology and Department of Periodontology, State University of New York at Buffalo, Buffalo, New York