5
Clinical Sciences Research

Reseach in the clinical sciences helps put into practice the discoveries that arise from the research in the fields described in the three previous chapters. Because the term “clinical research” is used to cover such a broad and diverse array of activities, its definition has proved to be controversial, primarily over the issue of whether the research does or does not require direct interaction with living patients or other human research subjects. The most expansive definition of clinical research is that agreed upon in 1998 at the Graylyn Clinical Research Consensus Development Conference, organized by the Association of American Medical Colleges (AAMC), the American Medical Association (AMA), and the Wake Forest University Medical Center. The Graylyn conferees defined

clinical research as a component of medical and health research intended to produce knowledge valuable for the understanding of human disease, preventing and treating illness, and promoting health. Clinical research involves interactions with patients, diagnostic clinical materials or data, or populations in any of the following areas: (1) disease mechanisms (etiopathogenesis); (2) bi-directional integrative (translational) research; (3) clinical knowledge, detection, diagnosis and natural history of disease; (4) therapeutic interventions including clinical trials of drugs, biologics, devices and instruments; (5) prevention (primary and secondary) and health promotion; (6) behavioral research; (7) health services research, including outcomes, and cost-effectiveness; (8) epidemiology; and (9) community-based trials.1

This definition was adopted by the U.S. Congress in the Clinical Research Enhancement Act (P.L. 110-148) of November 2000.

In response to this definition, those determined to carve out and distinguish research requiring direct interaction with living patients coined the term patient-oriented research. Another distinction is commonly made for translational research, which describes research that explores the applicability of the results of basic research to clinical care (for example, in clinical trials, especially early Phase 1 or 2 trials). In addition, translational research may also include studies of how to facilitate the introduction of newly established clinical knowledge into broad clinical practice and the obstacles thereto, or it may describe studies of the clinical effectiveness or cost effectiveness of new knowledge applied in clinical practice across very large and diverse populations. A publication authored by members of the Institute of Medicine’s Clinical Research Roundtable2 proposed that the first two of these different kinds of translational research, with their different strategies, technologies, time scales, training, and resource requirements, be distinguished as T1 and T2 and that the obstacles encountered be referred to as T1 blocks and T2 blocks, respectively. Subsequently, others have carried this terminology further by designating T3 blocks and even T4 blocks. This terminology has become widely accepted.

Despite the critical role that clinical research in all its forms plays in achieving the nation’s health goals, the clinical research enterprise has for years been underdeveloped. Recent scientific advances have begun to set the stage for a dramatic transformation of our capacity to diagnose, prevent, and treat disease and disability. But accomplishing this transformation will not only require the translation and wide-scale application of these increasingly remarkable basic research advances into health care practice, but will also demand profound changes in individual and group behaviors. The latter will not be achievable without substantially enhancing our understanding of individual and population behaviors, which in turn will require significantly greater investment in the

1

Summary of Report of the Graylyn Development Consensus Conference, November 1998, from Report 13 of the Council on Scientific Affairs (I-99), Update on Clinical Research. Available online at: http://www.ama-assn.org/ama/pub/article/2036-2392.html.

2

Sung, N.S., W.F. Crowley, Jr., M. Genel, P. Salber, L. Sandy, L.M. Sherwood, S.B. Johnson, V. Catanese, H. Tilson, K. Getz, E.L. Larson, D. Scheinberg, E.A. Reece, H. Slavkin, A. Dobs, J. Grebb, R.A. Martinez, A. Korn, and D. Rimoin. 2003. Central challenges facing the national clinical research enterprise. JAMA 289:1278-1287.



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5 Clinical Sciences research Reseach in the clinical sciences helps put into practice the Another distinction is commonly made for translational discoveries that arise from the research in the fields described research, which describes research that explores the appli- in the three previous chapters. Because the term “clinical cability of the results of basic research to clinical care (for research” is used to cover such a broad and diverse array of example, in clinical trials, especially early Phase 1 or 2 activities, its definition has proved to be controversial, pri- trials). In addition, translational research may also include marily over the issue of whether the research does or does not studies of how to facilitate the introduction of newly estab- require direct interaction with living patients or other human lished clinical knowledge into broad clinical practice and the research subjects. The most expansive definition of clinical obstacles thereto, or it may describe studies of the clinical research is that agreed upon in 1998 at the Graylyn Clinical effectiveness or cost effectiveness of new knowledge applied Research Consensus Development Conference, organized by in clinical practice across very large and diverse popula- the Association of American Medical Colleges (AAMC), the tions. A publication authored by members of the Institute American Medical Association (AMA), and the Wake Forest of Medicine’s Clinical Research Roundtable2 proposed that University Medical Center. The Graylyn conferees defined the first two of these different kinds of translational research, with their different strategies, technologies, time scales, clinical research as a component of medical and health training, and resource requirements, be distinguished as T1 research intended to produce knowledge valuable for the and T2 and that the obstacles encountered be referred to as understanding of human disease, preventing and treating T1 blocks and T2 blocks, respectively. Subsequently, oth- illness, and promoting health. Clinical research involves ers have carried this terminology further by designating T3 interactions with patients, diagnostic clinical materials or blocks and even T4 blocks. This terminology has become data, or populations in any of the following areas: (1) disease widely accepted. mechanisms (etiopathogenesis); (2) bi-directional integrative Despite the critical role that clinical research in all its (translational) research; (3) clinical knowledge, detection, forms plays in achieving the nation’s health goals, the clini- diagnosis and natural history of disease; (4) therapeutic inter- cal research enterprise has for years been underdeveloped. ventions including clinical trials of drugs, biologics, devices Recent scientific advances have begun to set the stage for a and instruments; (5) prevention (primary and secondary) and dramatic transformation of our capacity to diagnose, prevent, health promotion; (6) behavioral research; (7) health ser- vices research, including outcomes, and cost-effectiveness; and treat disease and disability. But accomplishing this trans- (8) epidemiology; and (9) community-based trials.1 formation will not only require the translation and wide-scale application of these increasingly remarkable basic research This definition was adopted by the U.S. Congress in the advances into health care practice, but will also demand pro- C linical Research Enhancement Act (P.L. 110-148) of found changes in individual and group behaviors. The latter November 2000. will not be achievable without substantially enhancing our In response to this definition, those determined to carve understanding of individual and population behaviors, which out and distinguish research requiring direct interaction with in turn will require significantly greater investment in the living patients coined the term patient­oriented research. Sung, N.S., W.F. Crowley, Jr., M. Genel, P. Salber, L. Sandy, L.M. 2 Summary of Report of the Graylyn Development Consensus Confer- Sherwood, S.B. Johnson, V. Catanese, H. Tilson, K. Getz, E.L. Larson, D. 1 ence, November 1998, from Report 13 of the Council on Scientific Affairs Scheinberg, E.A. Reece, H. Slavkin, A. Dobs, J. Grebb, R.A. Martinez, A. (I-99), Update on Clinical Research. Available online at: http://www. Korn, and D. Rimoin. 2003. Central challenges facing the national clinical ama-assn.org/ama/pub/article/2036-2392.html. research enterprise. JAMA 289:1278-1287. 

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8 RESEARCH TRAINING IN THE BIOMEDICAL, BEHAVIORAL, AND CLINICAL RESEARCH SCIENCES social and behavioral sciences to accomplish the transfor- culty, and costs of patient-oriented clinical research, and the mation of our health-care system from its primary focus on challenges these pose in competing successfully for spon- individual health care to a concentration on individual and sored research support, especially from National Institutes population health maintenance. of Health,3 (b) the sharply declining ability to cross-subsidize Health services research, which involves the study of the clinical research from hospital and faculty clinical practice efficiency, effectiveness, and costs of health care practices income as a result of the major changes wrought in health and systems, has become indispensable to understanding and care financing over the past 20 years, (c) the debt burden that informing the future of health care. Despite the promises of inclines many physicians in training to forgo clinical research a more rational and equitable health care marketplace envi- careers for the more likely rewards of clinical practice, and sioned in the Health Care Reform Act, health care costs have finally, (d) the still uncertain status of the full spectrum of been rising steadily for decades and consuming an increasing clinical research within the culture of the academic health fraction of the nation’s gross domestic product. Expenditures center, where traditionally, basic science and clinical prowess in the United States on health care surpassed $2.3 trillion in have often been valued more highly than clinical research. 2008, more than three times the $714 billion spent in 1990, Notwithstanding this formidable array of deterrents, abun- and over eight times the $253 billion spent in 1980. This dant anecdotal evidence indicates that physician-scientists relentless growth in costs, coupled with the aging of the who leave research careers often do so because of insufficient American population, the severe economic recession, and institutional support, a perceived lack of available mentors, the sharply rising federal deficit, is placing great strains on licensure regulations, and role models and the attendant the private-sector, state, and federal systems used to finance discouragement.4 health care, including private employer-sponsored health The need for increased investment in clinical research has insurance coverage and public insurance programs such as been increasingly recognized in diverse funding programs— Medicare and Medicaid. public, private, and philanthropic—as well as in academic The quality of the nation’s health care system has been an medical and health centers.5 These issues were addressed by issue for many years. In 2001, the IOM, launched an effort Task Force II, a group assembled by the AAMC to analyze to examine and recommend improvements in the nation’s the problems posed by the need to develop the full potential quality of care. Successive IOM reports have highlighted of clinical research. A number of the recommendations of the unacceptably poor status of our health care system as Task Force II have been realized, including the requirement a whole, the high frequency and costs of medical errors by the accrediting bodies of medical schools (ACME) and resulting as much from systemic as individual failures, the residency programs Accreditation Council for Graduate almost unique failure of the health care industry in com- Medical Education (ACGME), respectively, that all medi- parison with other sectors of the U.S. economy to adopt cal students and all residents be exposed to the principles and exploit powerful new information technologies, and of clinical research; having medical schools assume central the shameful and adverse consequences of the continuing oversight of clinical research training programs in order to problem of the uninsured. Another effort to highlight the ensure the “protected time” of trainee; and that academic quality of health care began in 2003 with the publication of medical centers invest in shared core facilities to support a series of reports by the Agency for Healthcare Research translational and clinical research. and Quality (AHRQ) that address the state of health care Nevertheless, that this underinvestment continues is indi- from the perspective of quality and disparity. These reports cated by the remarkably small fraction of the total annual describe in great detail the impact of the organizational, expenditures directed to health care that is invested in clinical administrative, financing, safety, access and other deficits of research. The NIH is the single largest public-sector source our cobbled-together health-care “system” on individuals, of funding for clinical research, and its commitment to clini - communities, businesses, and the entire nation. The need cal research has increased substantially since the late 1990s, to address these major problems makes it imperative that driven in part by the recommendations of the highly influen- “clinical research” be broadly conceived to encompass the tial report of the NIH Director’s Panel on Clinical Research, assessment of health outcomes, cost-effectiveness, finance, chaired by David G. Nathan and released in December 1997. access, information strategies, and other research related to Although NIH support of clinical research awards during the organization, deployment, utilization and quality of the Kotchen, T.A., T. Lindquist, A. Miller Sostek, R. Hoffmann, K. Malik, nation’s health-care systems and services. At this time it is 3 and B. Stanfield. 2006. Outcomes of National Institutes of Health peer difficult to estimate the impact of the 2010 Patient Protec- review of clinical grant applications. Journal of Investigative Medicine, tion and Affordable Care Health Care Reform Act on the 54:13-19. opportunities and challenges in clinical research. Dickler et al. 2007. “New Physician-Investigators Receiving National 4 There are many factors contributing to the continued Institutes of Health Research Project Grants.” JAMA 297(22):2496-2501. AAMC. 2006. “Promoting Translational and Clinical Science: The underdevelopment of the clinical research enterprise. These 5 Critical Role of Medical Schools and Teaching Hospitals.” Washington, include: (a) the extra time and expense required for clinical DC: AAMC; and Dickler, H, Korn, D, and Gabbe, SG, PLoS Med. 2006;3. research training along with the inherent complexity, diffi- e378.

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 CLINICAL SCIENCES RESEARCH BoX 5-1 recommendations from the association of american medical Colleges task force ii report, Promoting Translational and Clinical Science: The Critical Role of Medical Schools and Teaching Hospitals Recommendation 1: Every future physician should receive a thorough education in the basic principles of translational and clinical research, both in medical school and during residency training. Recommendation 2: The Liaison Committee on Medical Education (LCME) should add education in translational and clinical research to the requirements for medical school accreditation, and the Accreditation Council for Graduate Medical Education (ACGME) should embed understanding of translational and clinical research within its required core competencies. Recommendation 3: Training for translational and clinical investigators should comprise completion of an advanced degree with a thesis project (or an equivalent educational experience), tutelage by an appropriate mentor, and a substantive postdoctoral training experience. Recommendation 4: Sufficient support should be given to new junior faculty who are translational and clinical investigators to maximize their probability of success. Recommendation 5: Training in translational and clinical research should be accelerated through comprehensive re-structuring so that these scientists can become independent clinicians and investigators at the earliest possible time. Recommendation 6: Institutions, journals, the NIH, and other research sponsors should take steps to facilitate appropriate academic recognition of translational and clinical scientists for their contributions to collaborative research. Recommendation 7: The NIH should modify the K23 and K24 awards to enhance their value in supporting clinical and translational research training and mentoring. the proceeding two decades had remained largely constant community partners, as well as attracting non-biomedical at about 34 percent of total extramural research dollars, investigators from across universities into multidisciplinary the NIH has now launched several well-received training clinical research programs. However, it is too early to pre- awards for junior and mid-career physician scientists. There dict the ultimate success of this program or whether it will are also other support mechanisms, most notably the Clini- achieve its ambitious goals. cal and Translational Science Awards (CTSAs), directed by Notwithstanding these positive steps to enhance train- the National Center for Research Resources (NCRR) and ing and support for physician-researchers in the clinical launched in 2006, all of which are transforming the quality sciences, the past two decades have been particularly chal- and quantity of support of physician-scientists in universities lenging for the funding of all academic health professionals and academic health centers. Much of the NIH funding for and especially for the support of research activities in the the CTSA has been recovered from closing down the General clinical environment that are not clearly tied to specified Clinical Research Centers (GCRC) program, begun in the funding streams. Clinical research, broadly defined, has yet 1960s to create a national network of such centers, situated to achieve the breadth and depth of currency it deserves. primarily in academic health centers, and targeted initially To develop the nation’s clinical research capacity will to support what was then cutting-edge studies of metabolic require a sufficient workforce of highly trained clinician diseases in human research subjects. investigators in the several health research professions As of July 2010, 55 CTSAs had been funded in uni- as well as Ph.D.s in the diverse areas of knowledge that versities and academic health centers across the country, are encompassed in the expansive definition of “clinical creating local, regional, and national systems to increase research.” Building this workforce will require enhanced the efficiency and productivity of clinical and translational support across the clinical research disciplines and will research and to develop ways to reduce the time it takes for especially require supporting clinician-scientists, who must clinical research to become available for use in treatments be accomplished in both their clinical and their scientific for patients. The NIH intends that there will be 60 centers disciplines. when this program becomes fully implemented in 2012, although that number may increase. The CTSA—which defiNiNg the CliNiCal reSearCh WorkforCe require partnerships not only among academic medical insti- tutions and health centers with other components of universi- The clinical research workforce is as varied as the defini- ties, but also with community hospitals, clinics, and health tion of the field. It consists of individuals with doctorates in care practices—are truly creating increasing interest and the basic sciences, graduates of professional degree programs excitement in clinical research across universities and their (mostly M.D.s), graduates of health sciences and public

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0 RESEARCH TRAINING IN THE BIOMEDICAL, BEHAVIORAL, AND CLINICAL RESEARCH SCIENCES graduate StudeNtS health programs, and dual- or multiple-degree holders. These scientists play an important role in improving the capabilities The following discussion draws on data from the National and the delivery of the nation’s health care, because their Science Foundation Surey of Graduate Students and Post­ research spans the spectrum from discovery to delivery to doctorates in Science and Engineering and records indi- critical assessment of delivery and the functioning of the viduals who are studying in clinical departments (as defined health care enterprise. Some areas of research, however, are in Appendix C). The graduate student population in these purely clinical, such as health services, oral health, and nurs- clinical departments at doctoral-granting institutions grew by ing, and they will be addressed in later chapters of this report. 67 percent from 2000 to 2008 (see Figure 5-2). The growth We also address individuals who fit the expansive Graylyn in the number of graduate students is greater than that in the definition, which embraces research in health services and in other broad fields in this study where the size of the gradu - the social and behavioral sciences; these topics likewise will ate population has increased more slowly. It should also be similarly be addressed in later chapters of this report. noted that the robust growth is primarily reflects an increase With this definition in place, it has proved difficult to in the number of female graduate students (see Figure 5-2). analyze the specific number of individuals in the clinical (Nursing graduate students were excluded from the data, research workforce because current workforce databases because many of these students will not receive a doctorate, focus on their current research areas. Therefore, the basic and the pool of students pursuing a doctorate is discussed in workforce analysis for this report will include Ph.D.s with the nursing chapter.) degrees in the health fields listed in Appendix C, as well as However, one has to be very cautious in interpreting that fraction of the M.D. population in medical school clinical the data of Figure 5-2. Given the fact reported below that departments that conduct NIH-supported clinical research, only about 2,000 students graduated with a Ph.D. and that along with doctorates with a degree from a foreign institu- the best available evidence suggests that the time to degree tion that are in some way identified as clinical researchers. A was not much more than six years, we have to assume that major shortcoming of this approach is that does not capture 40 percent of the students listed in Figure 5-2 either quit the complete workforce, especially M.D.s who are involved or graduated with an M.S. degree. This is supported by the in the design and oversight of clinical trials and as well as observation (see Figure 5-3) that typically 30 to 40 percent those conducting research in non-medical areas of an aca- of these students were self-supporting, a circumstance more demic institution or in industrial laboratories. characteristic of master’s students than of those pursuing the Ph.D. The type of financial support the students in the clini- eduCatioNal BaCkgrouNd of the cal sciences receive is quite different from that in the other CliNiCal reSearCh WorkforCe fields (Figure 5-3). The problems discussed in identifying those currently graduate SuPPort aNd engaged in clinical research make it difficult to assess the the role of the NrSa iN traiNiNg educational background of clinical researchers in the same detail as is done for researchers in the biomedical and behav - Figure 5-3 shows the mechanisms of support for full- ioral and social sciences, because such studies can only be time graduate students in the clinical sciences. The number done for those individuals who are currently participating of traineeships and fellowships for graduate support in the in or have completed graduate programs that offer a Ph.D. clinical sciences has held relatively constant, at about 4,000 in the clinical fields. The difficulty of such an approach students each year over the past decade. Support for the to computing the overall workforce is underscored by the increased number of students has largely come from increased increasing numbers of Ph.D.s (both postdoctoral workers teaching assistantships, research assistantships, and, espe- and faculty) from the basic biomedical sciences who are cially, from self funding. The sources of external support pursuing careers in clinical departments of medical schools have also changed over time with NIH support growing from and at major teaching hospitals. There are presently more of 10 percent in 1979 to 25 percent in 2008, and non-federal these Ph.D.s employed in the clinical departments than in support (excluding self-support) growing from 25 percent to basic sciences departments. 60 percent over the same time period (see Figure 5-4). Many of these Ph.D.s, however, are likely to be involved NIH data for traineeships and fellowships shows a smaller in basic biomedical research, which happens to be performed number of National Research Service Awards (NRSAs) slots in the labs of M.D. or M.D./Ph.D. scientists involved in ranging from 823 in 2005 to 1,035 in 2008 (see Table 5-1). biomedical research, albeit in a clinical department environ- Like the other two broad fields in this study, support was ment. At present there is no way of distinguishing between rather constant in the 1990s. The decline in 2000 might Ph.D.s conducting basic biomedical research from those be the result of higher stipend levels and the fixed NRSA involved in clinical research (see Figure 5-1). budgets for the training programs. The difference among the numbers shown in Tables 5-1, 5-2, and Figure 5-4 is

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 CLINICAL SCIENCES RESEARCH 12,0 00 10,000 8,000 Number 6,00 0 4,0 00 2,000 Ph.D.s in Basic Science Departments Ph.D.s in Clinical Departments 0 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Year FIGURE 5-1 Tenured and tenure-track faculty by type of medical school department, 1990-2009. SOURCE: AAMC. Association of American Medical Colleges Faculty Roster, 00. 5-1.eps 25,00 0 Female Male 20,0 00 Number of Graduate Students 15,000 10,000 5,000 0 2000 2006 2004 2005 2008 2002 2003 2007 2001 1990 1996 1980 1984 1986 1988 1998 1999 1983 1985 1994 1995 1989 1992 1982 1993 1987 1997 1991 1979 1981 Year FIGURE 5-2 Full-time graduate enrollment in the clinical sciences. 5-2.eps SOURCE: NSF. 2008. Surey of Graduate Students and Postdoctorates in Science and Engineering. Washington, DC: NSF.

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 RESEARCH TRAINING IN THE BIOMEDICAL, BEHAVIORAL, AND CLINICAL RESEARCH SCIENCES 30,000 Fellowships Teaching Assistantships Traineeships Other Mechanisms of Suppor t 25,00 0 Research Assistantships Self-Suppor t Number of Full-Time Graduate Students 20,0 00 15,000 10,000 5,000 0 2000 2006 2004 2005 2008 2002 2003 2007 2001 1990 1996 1980 1984 1986 1988 1983 1985 1998 1999 1994 1995 1989 1992 1982 1993 1987 1997 1991 1979 1981 Year FIGURE 5-3 Mechanisms of support for full-time graduate students in the clinical sciences. SOURCE: NSF. 2008. Surey of Graduate Students and Postdoctorates in Science and Engineering. Washington, DC: NSF. 5-3.eps National Science Foundation National Institutes of Health 14,0 00 Health & Human Services ( Except NIH ) Department of Defense Other Federal Non-Federal (Self-suppor t not included) 12,0 00 Number of Full-Time Graduate Students 10,000 8,000 6,00 0 4,0 00 2,000 0 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 Year FIGURE 5-4 Sources of internal and external support of full-time graduate students in the clinical sciences. 5-4.eps SOURCE: NSF. 2008. Surey of Graduate Students and Postdoctorates in Science and Engineering. Washington, DC: NSF.

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 CLINICAL SCIENCES RESEARCH TABLE 5-1 NRSA Predoctoral Trainee and Fellowship TABLE 5-2 NRSA Postdoctoral Trainee and Fellowship Support in the Clinical Sciences (Excluding Health Support in the Clinical Sciences (Excluding Health Services) Services) Trainees (T32) Fellowship (F30, F31) Total Trainees (T32) Fellowship (F32) Total 1990 385 153 538 1990 1287 99 1386 1995 830 108 938 1995 1553 75 1628 2000 558 123 681 2000 1467 93 1560 2005 633 190 823 2005 1893 140 2033 2006 602 209 811 2006 1930 131 2061 2007 711 222 933 2007 1872 137 2009 2008 807 228 1035 2008 1968 143 2111 SOURCE: NIH database. SOURCE: NIH database. the result of NRSA support through other HHS agencies, of foreign-educated postdoctoral fellows increased from 25 primarily AHRQ. percent in 1983 to 45 percent in 2008. The growth in the graduate population is naturally reflected Detailed data are not collected on the source of clinical in the number of doctoral degrees in the clinical sciences research training support at the postdoctoral level by indi- fields, with more than a six-fold increase from the early vidual federal agency, but the type of training support, at 1970s, and much of the increase involves an increased par- least in academic institutions is available (Figure 5-6). The ticipation by women. The modest increase in male Ph.D.s is traineeships and fellowships portion has been increasing at similar to what has happened in the graduate population more a slow rate, while in contrast the number of individuals on generally (Figure 5-5). The citizenship of doctorates in the research grants has increased five-fold since the late 1970s. clinical sciences differ from those in the biomedical sciences The NRSA contribution to postdoctoral training support with about 16 percent awarded to temporary residents and 6 mirrors the general trend for fellows and trainees, but at a percent to permanent residents. However, minority participa- lower level, because support is available from sources other tion accounted for about 12 percent of the degrees in 2008. than NRSA (see Table 5-2). PoStdoCtoral felloWS the CliNiCial reSearCh WorkforCe Among Ph.D.s in the three fields, reviewed in this report, It is extremely difficulty to determine the number of those in the clinical sciences are the least likely to have individuals contributing to the clinical research workforce postdoctoral training, because less than 20 percent have from the available data. The primary sources of data are the traditionally planned such study versus the 30 percent and NSF Surey of Doctorate Recipients and the AAMC Faculty nearly 70 percent in the behavioral and biomedical sciences, Roster. In the former dataset Ph.D.s are classified by the area respectively. It is likely that this small number of individuals in which they receive their degree as defined according to the specifically educated in research in the clinical sciences fields listed in Appendix C. Since these are considered to be represents a minimum estimate of those involved in this clinical fields, we surmise that they are likely to be conduct- type of research. One might add two additional categories ing clinical research. The AAMC dataset is comprehensive to this postdoctoral pool, namely (a) individuals educated with regard to Ph.D.s in clinical departments in medical in basic biomedical research who have shifted to clinical schools, but as mentioned earlier conducting research in a research (and who may be expected to reside in clinical clinical department does not imply that the research is clini- departments) and (b) international postdoctoral researchers cal. Indeed, it is quite likely that individuals with Ph.D.s in trained in clinical research. One might be tempted to com- either basic sciences or clinical departments are conducting pute these numbers from the number of postdoctoral fellows biomedical research. With this in mind, because individuals in clinical departments. However it is clear that over the with different degrees conduct clinical research and no data past two decades many Ph.D. postdoctorates and faculty source comprehensively captures their activities, it is best to in clinical departments have in fact conducted basic bio- look at the workforce from the perspective of the different medical research, although the exact fraction of the total pool degrees that lead to a clinical researcher. The basic clini- involved in clinical research is impossible to determine from cal workforce, as described by the NSF data, is composed the available data sources. Reflecting this point is the fact that of those 23,282 individuals in 2006 with a Ph.D. in those the fraction of all postdoctoral fellows with medical degrees clinical fields characterized in Appendix C. This number is (not resident fellows) in clinical departments decreased from the potential workforce of individuals employed or seeking 61 percent in 1983 to 22 percent in 2008, while the number employment. Those employed in S&E number 22,229. More

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 RESEARCH TRAINING IN THE BIOMEDICAL, BEHAVIORAL, AND CLINICAL RESEARCH SCIENCES 1,600 Male Female 1,40 0 1,20 0 Number of Doctorates 1,000 800 600 40 0 200 0 2000 2006 2004 2005 2008 2002 2003 2007 2001 1990 1996 1998 1999 1994 1995 1992 1993 1997 1991 Year FIGURE 5-5 Doctoral degrees awarded in the clinical sciences. SOURCE: NSF. 2008. Surey of Earned Doctorates. Washington, DC: NSF. 5-5.eps 16,0 00 Fellowships Traineeships Research Grants Non-Federal Sources 14,0 00 Number of Suppor ted Postdoctorates 12,0 00 10,000 8,000 6,00 0 4,0 00 2,000 0 2000 2006 2004 2005 2008 2002 2003 2007 2001 1990 1996 1980 1984 1986 1988 1998 1999 1983 1985 1994 1995 1989 1992 1982 1993 1987 1997 1991 1979 1981 Year FIGURE 5-6 Academic postdoctoral support in the clinical sciences, 1979-2008. SOURCE: NSF. 2008. Surey of Graduate Students and Postdoctorates in Science and Engineering. Washington, DC: NSF. 5-6.eps

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 CLINICAL SCIENCES RESEARCH current data on the Ph.D.s in the workforce are not avail- ate. From 1986 to 2006 the median age of the workforce has able, but the AAMC roster of medical school faculty has increased from being in the 41 to 43 age cohort in 1986 to data through 2009. The number of M.D.s conducting clini- the 51 to 52 cohort in 2006 (Figure 5-10). The aging of the cal research in medical schools can be estimated from the clinical workforce is also seen in the data from the AAMC number with R01 support in 2006 at about 2,950 and 2,850 Faculty Roster where the median age of the medical school in 2009. In addition there were about 1,450 M.D.s in 2006 faculty has increased from about 46 years to 52 years from and 1,550 in 2009 with other non-R01 forms of grant sup- 1989 to 2009 (see Figure 5-11). port from the NIH. A longitudinal examination of NIH data6 The lower level of interest among postdoctoral training over a 40-year time span shows that the number of M.D.s among those Ph.D. holders in fields listed in Appendix C is applying for a first R01 grant has remained remarkably flat shown in Appendix Table F-5 and is reflected in the portion over most of that interval, and that in 2004 (the last year for of the workforce that is working in postdoctoral positions. which data were available) the number of M.D./Ph.D.s and Only about 2 percent of the clinical U.S. Ph.D.s have held M.D.s applying for a first R01 had become almost identi- postdoctoral positions in recent years and almost all are in cal. Of course, neither of these counts captures the clinical academic institutions. If the faculty in clinical departments researchers in the M.D. population that have support from is examined, the picture is somewhat different. There are non-NIH sources. As has been stressed repeatedly, even if we about 8,000 U.S. citizens or permanent residents in these can ascertain the total number of M.D.s with R01 support it positions. The difference between in Appendix Table F-6 and is still difficult to determine how many of these grants are Figure 5-12 is probably the result of Ph.D.s with biomedical for basic science alone. degrees getting their training in clinical departments. Thus the overall workforce is composed of approximately Table F-5 also shows that minorities only represented 12,000 graduate students, 5,000 postdoctoral fellows, some 8.6 percent of the clinical research population in 2006, 23,000 Ph.D.s beyond the postdoctoral stage, a number of even though their numbers grew from about 100 in 1973 to M.D.s that is poorly defined but probably not more than a little more than 1,100 in 2006. This is better than in the 1,000, and an unknown number of foreign-born scientists biomedical sciences and about the same as in the behavioral working in this area. The total number then is at least 41,000, and social sciences. The data show, as they did for the other of which 24,000 completed their graduate and postdoctoral fields, a small number of temporary residents in the research education (see Figure 5-7). The overall clinical workforce, population, but since the data reflect only those individuals including postdoctoral fellows, has grown significantly from who were trained in U.S. institutions, there may be a larger about 2,850 in the early 1970s to the current level. Much of percentage of temporary residents in the workforce with this growth has been in the academic sector, but the industrial foreign doctorates. sector has also shown a significant increase as is shown in Although the number of M.D. clinical researchers is not Figure 5-6. As was the case with the educational charac- known exactly it appears that in recent years individuals with teristics of clinical Ph.D.s, data on their career progression a Ph.D. have dominated the field. In the 1970s only 2,600 and employment characteristics are only well known for Ph.D.s made up the workforce, and only a few hundred Ph.D.s from U.S. institutions. The steady growth in the aca- degrees were awarded each year. There did not appear to be demic sector in the past decade has been due in part to the a change in the number of M.D.s in clinical research since employment of non-tenure-track faculty and other academics the 1970s, even though the Ph.D. workforce grew by a fac- (usually research associates) who jointly made up about 40 tor of seven during that time. There may be several reasons percent of the faculty in 2006 (see Figure 5-8). for this change, but a primary one is probably the increased Tenured and tenure-track faculty hold the majority of the educational debt of medical school graduates. Except for positions, but their percentage has fallen from around 80 graduates of dual-degree (e.g., M.D./Ph.D. or D.D.S.//Ph.D.) percent in the mid-1980s to 60 percent in 2006. This decline programs, most physicians and dentists today begin their is not surprising, because there has been a movement by professional careers with sizable educational debts. institutions toward temporary or soft money positions by In 2009, the AAMC reported that the average educational institutions in many fields in recent years. This change in the debt of current graduates was $156,456, with 79 percent composition of the faculty is confirmed in the AAMC data of the graduates having a debt of at least $100,000 and 58 for medical schools, which show that from 1980 to 2009 the percent having a debt of at least $150,000. The level of percentage of Ph.D. faculty in non-tenure-track positions in educational debt for dental students is comparable to that clinical departments increased from about 35 percent to near of medical students. In 2006, the average it was more than 60 percent (see Figure 5-9). $130,571, and 72 percent had an educational debt of more A concern for the clinical research workforce is the than $100,000. The increased debt results from the practice increase in the age at which individuals receive their doctor- in dental schools that requires students to purchase their den- tal instruments during their clinical training. Although health care professionals are permitted to postpone payments on Dickler et al. 2007. “New Physician-Investigators Receiving National 6 their student loans during NRSA or other authorized research Institutes of Health Research Project Grants.” JAMA 297(22):2496-2501.

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 RESEARCH TRAINING IN THE BIOMEDICAL, BEHAVIORAL, AND CLINICAL RESEARCH SCIENCES 25,00 0 Academics Industry 20,0 00 Government Other Sect 15,000 Number 10,000 5,000 0 1973 1975 1977 1979 1981 1983 1985 1987 1989 1991 1993 1995 1997 1999 2001 2003 2006 Year FIGURE 5-7 Employment sectors of the clinical workforce 1973-2006. SOURCE: NSF. Surey of Doctorate Recipients, ­00. Washington, DC: NSF. 5-7.eps 16,0 00 Tenured Faculty 14,0 00 Tenure-Track Faculty Non-Tenure-Track Faculty Postdocs 12,0 00 Other Academics 10,000 Number 8,000 6,00 0 4,000 2,000 0 1973 1975 1977 1979 1981 1983 1985 1987 1989 1991 1993 1995 1997 1999 2001 2003 2006 Year FIGURE 5-8 Academic appointments in the clinical sciences, 1973-2006. 5-8.eps SOURCE: NSF. Surey of Doctorate Recipients, ­00. Washington, DC: NSF.

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 CLINICAL SCIENCES RESEARCH 70 Tenured Tenure Track, Not Tenured 60 Non-Tenure Track Tenure Is Not Available 50 40 Percent 30 20 10 0 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Year FIGURE 5-9 Tenure status of Ph.D.s in clinical departments in medical schools, 1980-2009. SOURCE: AAMC. Association of American Medical Colleges Faculty Roster, 00. 5-9.eps 10 0 90 1986 1993 2006 80 70 60 Percent 50 40 30 20 10 0 25 -26 27-28 29 -30 31-32 33 -34 35 -36 37-38 39 -40 41-42 43 -44 45 -46 47-48 49 -50 51-52 53 -54 55 -56 57-58 59 -60 61-62 63 -64 65 -66 67-68 69 -70 71-72 73 -74 75 -76 Age Cohor ts FIGURE 5-10 Cumulative age distribution for the clinical workforce. SOURCE: NSF. Surey of Doctorate Recipients, ­00. Washington, DC: NSF. 5-10.eps

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8 RESEARCH TRAINING IN THE BIOMEDICAL, BEHAVIORAL, AND CLINICAL RESEARCH SCIENCES 100 90 80 70 1989 60 1999 Percent 50 2009 40 30 20 10 0 Age Cohorts FIGURE 5-11 Age distribution of Ph.D.s on medical school faculty in clinical departments in 1989, 1999, and 2009. SOURCE: AAMC. Association of American Medical Colleges Faculty Roster, 00. 16,0 00 U.S. Ph.D. Postdoctorates 11.eps M.D. Postdoctorates 5- U.S. 14,0 00 vector replacemen.tD. Postdoctorates Foreign Ph.D. Postdoctorates Foreign M 12,0 00 10,000 Number 8,000 6,00 0 4,000 2,000 0 2000 2006 2004 2005 2008 2002 2003 2007 2001 1990 1996 1984 1986 1988 1998 1999 1983 1985 1994 1995 1989 1992 1993 1987 1997 1991 Year FIGURE 5-12 Clinical postdoctoral fellows by degree type. SOURCE: NSF. 2008. Surey of Graduate Students and Postdoctorates in Science and Engineering. Washington, DC: NSF. 5-12.eps

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 CLINICAL SCIENCES RESEARCH training programs, this option may not be widely used, and F30 DSTP—in 16 different dental schools (only 2 of these even if it were used, additional training places financial and schools do not have T32 DSTP trainees). other burdens on a young physician. A student in a typical M.D./Ph.D. program begins inten- Congress has authorized several educational loan repay- sive research training after the second year of medical school. ment programs for M.D.s who enter clinical research training At this point in their training, the students have had little programs, for minority M.D.s who pursue clinical training, exposure to clinical medicine and the challenges and research and for others pursuing designated career paths. There are opportunities that are inherent therein. After three-plus years perhaps a half-dozen different programs authorized, and the completing work required for the Ph.D. degree, the students NIH has been vigorous in making these programs known return to the medical curriculum for the third and fourth years. to successful candidates. The explicit purpose of these For dual-degree graduates who elect to pursue full clinical programs is to mitigate educational debt burdens for M.D.s specialty training, an additional three to five, or more, years pursuing clinical research training. M.D. graduates from typically ensue before the individuals can turn their attention clinical research training programs (e.g., those receiving fully to research. At that point, to begin an additional formal one of the several K awards) must have protected time to program of clinical research training is unappealing. develop their independent research careers, an increasingly The M.D./Ph.D. programs were envisioned as a way difficult situation in today’s increasingly competitive health to bring more M.D.s into clinical research, but in practice care markets. Another obstacle is the limitation on salaries r elatively few participants receive research training in for NIH-funded physician-investigators. The cap is set annu- clinical research methods, and only about 20 percent of ally set by Congress to be no more than that of an executive the M.D./Ph.D.s actually go on to pursue clinical research grade; this grade has varied in recent years between level II careers. Educational debt does not appear to be the reason, and level I. It is now set at $199,700, and although that is because their debt averaged about $15,000 in 2006. Many not an insignificant amount, it is below what many practicing have argued that these programs are not effective in training clinicians or medical faculty can earn. clinical researchers because of their structure. An analysis in 1996 of the fields of study chosen by MSTP participants found that nearly 60 percent of graduates from the late dual-degree training 1980s and early 1990s had their Ph.D.s in five basic science In addition to predoctoral and postdoctoral program sup- fields: biochemistry, neuroscience, molecular biology, cell port in the clinical sciences through the NRSA mechanism, biology, and pharmacology. As a consequence the work dual-degree programs are another attractive option for health they were exposed to in their Ph.D. program was focused on care professionals seeking clinical research training. The basic research, and this attracted them to a research career NIH currently, has three dual-degree training programs: in the biomedical sciences. As a result in their subsequent (1) the Medical Scientist Training Program (MSTP), (2) indi- research careers, MSTP graduates focused almost entirely vidual M.D./Ph.D. fellowships, and (3) the Dental Scientist on laboratory-oriented research, albeit typically in clinical Training Program (DSTP). departments and in areas of relevance to that clinical disci- These dual-degree programs are very attractive, because pline, and they sought NIH funding for such research projects they provide students with several career options, and the at the same rate as Ph.D.s. level of educational debt that students are left with is much Recognizing this problem NIGMS has recommended that lower than that for regular M.D. students. The MSTP in the institutions provide broader opportunities within the M.D./ National Institute of General Medical Sciences (NIGMS) Ph.D. training mechanism. The institute issued new guidelines is the largest and oldest programs, dating back to 1964, for the MSTP that urged medical schools with such training and today it funds 880 students training at 35 medical grants to extend their programs in order to give students “a schools and universities. An additional 31 MSTP trainees breadth of doctoral research training opportunities” in fields are supported by other institutes. Offering fellowships for including computer science, the social and behavioral sciences, M.D./Ph.D. training is more recent; they were instituted economics, epidemiology, public health, bioengineering, bio- in 1989 by the National Institute of Mental Health, the statistics, and bioethics. However, most M.D./Ph.D. programs National Institute on Alcohol Abuse and Alcoholism, and have been slow to respond, and there has been little change in the National Institute on Drug Abuse to encourage dual- the descriptions of the programs. And in most cases, the basic degree training in the areas of mental health, behavior, and structure of two years/three years/two years persists. neuroscience. The fellowship program is much smaller in In addition to formal dual M.D./Ph.D. programs, other scale, supporting about 140 new students each year. The approaches are being tried to attract M.D.s to clinical latest type of dual-degree training to be introduced is the research. Examples include master’s level programs in DSTP, which was created following the recommendations specific clinical areas, which are becoming popular in some from the 1994 study of the NRSA program. The National r esearch-oriented medical schools and which may be Institute of Dental and Craniofacial Research supports designed to provide academic formal training in such areas about 90 dual-degree dental students through the T32 and as quantitative and methodological principles of medical

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80 RESEARCH TRAINING IN THE BIOMEDICAL, BEHAVIORAL, AND CLINICAL RESEARCH SCIENCES reCommeNdatioNS genomics, epidemiology, biostatistics, clinical trial design and analysis, etc. These programs appear to be very attrac- Recommendation 5–1: The total number of NRSA posi- tive to medical students and may encourage them to pursue tions awarded should remain at least at the 2008 level. careers as physicians in clinical research. Furthermore, training levels after 2008 should be com- Clearly, identifying optimal training mechanisms for mensurate with the rise in the total extramural research attracting medical students to clinical research, and then struc- funding in the biomedical, clinical, and behavioral and turing effective training programs to prepare the students and social sciences. A decline in extramural research would graduates for successful clinical research careers, remains a also call for a decline in training. large challenge for the biomedical community and the funding agencies. Toward this end, the recent adoption by the ACME Recommendation 5–2: The NIH, in consultation with and the ACGME of recommendations from the AAMC’s academic medical leadership, should exercise leadership Task Force II on Translational and Clinical Research, viz., in identifying better training mechanisms for attracting that medical students and residents should be exposed to the medical students into translational and clinical research, basic principles of translational and clinical research and to the and the NIH should fund pilot programs designed to research challenges and opportunities therein, may over time implement promising new approaches to accomplishing increase the population of medical graduates with a keen inter- that objective. est in pursuing clinical research careers. Finding mechanisms that will encourage students in these dual-degree programs to conduct clinical research continues to be a challenge.