2
The Clinical Research Workforce: Across-the-Board Challenges

Over the past two decades policy makers, researchers, and others have consistently expressed concern about the state of the clinical research workforce (Wyngaarden, 1979; Ahrens, 1992; IOM, 1994; NIH, 1997; Zemlo et al., 2000). At the same time, expectations have grown about possibilities of translating new life sciences knowledge into health benefits (NIH, 1997; Zemlo et al., 2000; Elliott, 2001; Fey, 2002; Bloom, 2003; Gerling et al., 2003; Mike, 2003).

Because the challenges of a clinical research career are very different from those of a basic science career, the study committee believed a general overview of clinical research would be helpful in understanding how these challenges particularly affect women and underrepresented minorities. Hence, this chapter will provide a view of the challenges facing the clinical research workforce overall. This includes an overview of the efforts by the National Institutes of Health (NIH) to promote clinical research over the past decade, as well as a discussion of the clinical research workforce challenges of the private sector, a major sponsor of clinical research.

As noted in Chapter 1, since 1975 NIH has monitored the workforce and training needs for all biomedical research, including clinical research (NRC, 2005a). The reports issued in conjunction with this monitoring have pointed out that the primary obstacle to estimating workforce and training needs for the clinical research community was the lack of data on the clinical research workforce.



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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 2 The Clinical Research Workforce: Across-the-Board Challenges Over the past two decades policy makers, researchers, and others have consistently expressed concern about the state of the clinical research workforce (Wyngaarden, 1979; Ahrens, 1992; IOM, 1994; NIH, 1997; Zemlo et al., 2000). At the same time, expectations have grown about possibilities of translating new life sciences knowledge into health benefits (NIH, 1997; Zemlo et al., 2000; Elliott, 2001; Fey, 2002; Bloom, 2003; Gerling et al., 2003; Mike, 2003). Because the challenges of a clinical research career are very different from those of a basic science career, the study committee believed a general overview of clinical research would be helpful in understanding how these challenges particularly affect women and underrepresented minorities. Hence, this chapter will provide a view of the challenges facing the clinical research workforce overall. This includes an overview of the efforts by the National Institutes of Health (NIH) to promote clinical research over the past decade, as well as a discussion of the clinical research workforce challenges of the private sector, a major sponsor of clinical research. As noted in Chapter 1, since 1975 NIH has monitored the workforce and training needs for all biomedical research, including clinical research (NRC, 2005a). The reports issued in conjunction with this monitoring have pointed out that the primary obstacle to estimating workforce and training needs for the clinical research community was the lack of data on the clinical research workforce.

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 NIH INVESTMENT IN THE CLINICAL RESEARCH WORKFORCE In 1994 the Institute of Medicine (IOM) issued a report on careers in clinical research that focused on three major issues: (1) accurate data on the numbers of clinical researchers, (2) career training support and funding, and (3) a systematic review of research administration and infrastructure (IOM, 1994). In 1995 NIH convened a director’s advisory panel to examine the challenges facing clinical research, such as financing, the role of clinical research centers, the recruitment and training of its workforce, and the conduct of clinical trials and peer review. The actions produced by the recommendations of the advisory panel were instrumental in advancing clinical research in three ways. First, NIH adopted definitions for clinical research that allowed better collection of data, and it constructed a landscape view of who had taken up careers in clinical research (NRC, 2000). Second, NIH examined the composition and outcomes of study sections to ensure that clinical research proposals were being reviewed by those with clinical expertise. Third, NIH developed mechanisms for the training and support of clinical investigators (e.g., a series of K awards and the Clinical Research Loan Repayment Program). More recently NIH embarked on an ambitious new plan for medical research in the twentieth-first century, the Roadmap for Accelerating Medical Discovery to Improve Health, which features a major emphasis on clinical research. Re-engineering the Clinical Research Enterprise aims to facilitate the bench-to-bedside transition through, among other things, enhanced regional clinical research centers that incorporate academic health centers as well as community-based healthcare providers, better organization of the gathering of clinical research information, better information technology, and ways to enhance the workforce. Within NIH itself, a panel to examine intramural clinical research has been established to provide guidance and review. (Intramural research is conducted within NIH laboratories. Extramural research is conducted by researchers at academic institutions that receive grants from the NIH.) NIH Director’s Panel on Clinical Research (1996): Status NIH has not changed the proportion of clinical research support since the launch of the NIH Director’s Panel on Clinical Research in 1996.1 By 1   William Crowley Jr., M.D., workshop presentation, 2003.

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 TABLE 2-1 NIH Clinical Research Awards, FY 1996-FY 2001 Fiscal Year Total Competing Awards Clinical Research Awards Percent of Total Clinical Research Number Amount ($ millions) Number Amount ($ millions) Awards Funding 1996 10,493 2,361 2,795 906 27 38 1997 11,592 2,572 2,767 877 24 34 1998 11,780 2,984 2,882 1,000 24 34 1999 13,971 3,946 3,470 1,257 25 32 2000 15,357 5,278 3,862 1,722 25 33 2001 14,622 4,717 3,874 1,609 27 34   SOURCE: NIH (2002a). 2001, NIH grants had increased by almost 50 percent, representing more than a 50 percent increase in their dollar value (see Table 2-1). The increase in clinical research grants has been roughly comparable to the increase in total competing awards. M.D. or Ph.D. rates of applications have seen slight improvements. The number of awards has increased substantially for first-time M.D. applicants, but as of 2001 there had been no significant change in the number of applicants (see Table 2-2). The same is true for Ph.D.s. Between 1997 and 2001 the overall M.D. success rate increased to between 32 percent and 35 percent (see Table 2-3). The average growth rate for M.D. applicants was only 2.30 percent versus 4.05 percent for Ph.D.s. A concern is whether this flat rate of growth will ensure an adequate supply of M.D. applicants in an increasingly clinic-oriented research environment. The renewal rate for RO1-funded (RO1’s are research grants awarded to independent investigators at academic institutions) clinical investigators has been lower than that of nonclinical research grantees. A little over 30 percent of all nonclinical investigators who received awards in 1996 and reapplied in 1999-2001 were renewed, whereas only 17 percent of clinical research investigators were renewed. Of the 405 clinical researchers who applied for awards in 1966, only 47 percent sought renewal, versus the 68 percent of the 954 nonclinical researchers who sought awards in 1996.2 Although targeted clinical research career awards have been successful, the

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 TABLE 2-2 First-time NIH Applicants and Awards, FY 1995-FY 2001 Fiscal Year M.D.s Ph.D.s No. of Applicants No. of Awards Success Rates (%) No. of Applicants No. of Awards Success Rates (%) 1995 2,150 385 17.9% 5,136 982 19.1% 1996 1,930 399 20.7% 4,802 952 19.8% 1997 1,915 408 21.3% 4,671 1,042 22.3% 1998 1,876 425 22.7% 4,452 1,059 23.8% 1999 1,965 489 24.9% 4,853 1,052 21.7% 2000 1,941 491 25.3% 4,892 1,078 22.0% 2001 1,962 470 24.0% 4,893 1,055 21.6%   SOURCE: Nathan and Wilson (2003). TABLE 2-3 M.D. and Ph.D. NIH Applications, Awards, and Success Rates, FY 1990-FY 2001 Fiscal Year M.D.s Ph.D.s No. of Applicants No. of Awards Success Rates (%) No. of Applicants No. of Awards Success Rates (%) 1990 5,707 1,484 26.0% 15,281 3,683 24.1% 1991 5,784 1,677 29.0% 15,112 4,337 28.7% 1992 5,705 1,740 30.5% 15,575 4,548 29.2% 1993 6,408 1,512 23.6% 16,638 3,960 23.8% 1994 7,283 1,792 24.6% 17,646 4,570 25.9% 1995 7,004 1,891 27.0% 17,680 4,738 26.8% 1996 6,338 1,787 28.2% 16,979 4,771 28.1% 1997 6,515 2,058 31.6% 17,214 5,164 30.0% 1998 6,513 2,143 32.9% 17,162 5,252 30.6% 1999 7,481 2,672 35.7% 18,382 5,775 31.4% 2000 7,925 2,712 34.2% 19,041 5,896 31.0% 2001 7,998 2,839 35.5% 19,816 6,137 31.0%   SOURCE: Nathan and Wilson (2003).

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 TABLE 2-4 Targeted NIH Clinical Research Awards (Type 1: K23, K24, and K30), FY 1999-FY 2003 Fiscal Year K23 K24 K30 Total 1999 85 81 35 201 2000 193 77 22 292 2001 185 58 0 243 2002 194 48 2 244 2003 214 40 0 254 Total 871 304 59 1,234   SOURCE: Walter Schaffer, NIH IMPAC-II, October 7, 2003. number of K24s has decreased consistently. The loan relief programs and K30s have been critical in relieving medical student debt. The K30 programs meet educational needs, but they are for people still in training, not for independent investigators (see Table 2-4). NIH Director’s Blue Ribbon Panel on the Future of Intramural Clinical Research The Blue Ribbon Panel on the Future of Intramural Clinical Research3 was convened in August 2003 by NIH Director Zerhouni in response to three events: (1) the building of the new Clinical Research Center (CRC), (2) the NIH roadmap, and (3) changing approaches in academic health centers (AHCs) to clinical research. The following questions were posed to the panel: In what areas not addressed by other NIH-supported research can the Intramural Clinical Research Program (ICRP) produce paradigm-shifting research? Is the current ICRP portfolio suitable? How can the ICRP enhance the overall NIH-supported clinical research enterprise? 2   Ibid. 3   See http://www.genome.gov/Pages/About/NACHGR/2004NACHGRAgenda/Tab%20H%20-%20BlueRibbonPanel.pdf. Date accessed October 19, 2004.

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 How can this be accomplished by reassigning existing resources to excellent, distinctive intramural programs in a steady-state environment? What measures should be used to assess the success of the ICRP? Based on the charges to the panel, recommendations were made to promote the status of clinical research within the NIH enterprise (see Box 2-1); NIH developed responses to the recommendations. The ICRP should adopt streamlined, comprehensive governance. Rather than being an impediment to innovation, the governance structure should help the clinical research enterprise to realize its full potential. The career pathways of patient-oriented research should be strengthened and rewarded. Creating a clear and rewarding career path for clinical investigators is an essential first step toward attracting and retaining clinical investigators committed to conducting patient-oriented research. NIH could champion the development of new therapies for several rare diseases in order to potentially affect the economics of drug development and serve an unmet medical need. By focusing on diseases with which NIH investigators have special expertise, the intramural program could enhance downstream clinical investigation. Clinical research should have general clinical research center (GCRC) and children’s clinical research center (CCRC) multicenter networks. Improvements in the infrastructure will be needed to revitalize the roles of GCRCs and CCRCs in clinical research and establish them as centers of innovation. A focus on research that defines a more distinctive niche in the U.S. biomedical research portfolio and takes on projects that cannot be included in the extramural program should be included in future directions. The intramural program has fewer short-term constraints than the extramural program and is particularly well equipped for the conduct of innovative and bold research. Streamlining, regulatory reform, and standardization are needed. Any steps to encourage investigators to initiate new protocols and harmonize the demands placed on clinical research from different regulatory agencies will require making the regulatory and review processes for intramural research more efficient and uniform across institutions.

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 BOX 2-1 Recommendations of the 2003 NIH Director’s Blue Ribbon Panel on the Future of Intramural Clinical Research Revise the NIH intramural clinical research oversight structure. Create a single, high-level oversight committee to replace all existing governing bodies that have oversight responsibilities for intramural clinical research. Create an external advisory committee that reports to the NIH director to periodically and systematically consider the overall quality and vitality of the NIH Intramural Clinical Research Program. Strengthen the roles of the Office of the Director and institute and center leadership in clinical research. Develop new training and career pathways in patient-oriented research. Strengthen career pathways and mentoring in the ICRP for patient-oriented research that culminate in tenure. Establish a premier, highly visible postdoctoral fellowship program in clinical research, administered by the CRC director, for individuals who have finished clinical residency training. Create an advanced research training program for extramural faculty members in AHCs who wish to take sabbatical at the CRC as a means of obtaining on-the-job experience in clinical research. Foster the recruitment and retention of innovative patient-oriented investigators in the ICRP by ensuring that salaries and benefits are competitive with those at AHCs. Foster an interactive and creative research environment that will attract outstanding postdoctoral fellows. Postdoctoral fellows will want to participate in programs that are conducting disease-oriented research or investigating timely clinical problems that cannot easily be studied in extramural AHCs.

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 Continue to emphasize the study of rare diseases at the CRC and promote a strong emphasis on pathophysiology and novel therapeutics in the ICRP. Initiate trans-NIH programs of patient-oriented research that combine the expertise of several institutes and centers. Make the best use of the unique features of NIH’s intramural research program and its ability to undertake bold and innovative research. Create clinical, multidisciplinary intramural and extramural partnerships involving the GCRCs, CCRCs, NIH-funded extramural networks, the CRC, and the ICRP. Ensure that Intramural clinical research, including new programs in patient-oriented investigations, is excellent and distinctive, as well as distinguishable from research conducted at AHCs. This mandate for change should be the responsibility of the NIH director, institute and center leaders, the advisory committees, and the basic science centers. Reduce regulatory barriers and impediments to clinical research. This would include streamlining the regulatory process and providing adequate, effective infrastructure for supporting clinical research. SOURCE: NIH (2004).

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 WORKFORCE CHALLENGES FOR THE PRIVATE SECTOR IN CLINICAL RESEARCH As innovators in drug development, the pharmaceutical industry has always been an active participant in clinical research. In 2002 the total worldwide expenditures by major pharmaceutical companies for research and development (R&D) were $44.5 billion, of which 62 percent was devoted to pre-approval (Phases I-III) and 38 percent to Phases IIIb-IV (PhRMA, 2004).4 Industry maintains a steady proportional investment in R&D—18 percent of sales. In the United States, Phase I spending in 2002 exceeded $1.8 billion; spending on Phase II and Phase III clinical research projects was $2.3 billion and $3.6 billion, respectively; and Phase IV spending reached $1.5 billion (Thomson CenterWatch, 2004). It is not uncommon for Phases I-III of a drug development program to involve as many as 10,000 or more patients before a drug is approved. If investigators want to host drug development programs and patients are in relatively short supply, many different centers do the research, that is, from 100 to 1,000 research centers around the world recruit the patients needed for a particular clinical development program. Patient recruitment and retention remain the largest problems in drug development, despite significant increases in spending to reach and randomize study volunteers (Thomson CenterWatch, 2004). As a result, clinical research has moved away from small focused studies within academic institutions to large multicenter trials, including more community physicians (Phillips, 2000; Randal, 2001; Gelijns and Thier, 2002). Recruiting Clinical Investigators Some 100,000 physicians are in training in the United States, which is the beginning of the clinical research pipeline. From this pool 1,700 physicians were hired in 2002 to full-time AHC clinical positions. The 87,000 clinical faculty in academic health centers are an important source for 4   “R&D expenditures” are defined as expenditures within PhRMA member companies’ U.S. and or foreign research laboratories plus R&D funds contracted or granted to commercial laboratories, private practitioners, consultants, educational and nonprofit research institutions, manufacturing and other companies, or other research-performing organizations. “Phases I/II/III clinical testing” is defined as from first testing in designated phase to first testing in subsequent phase. “Phase IV clinical testing” is defined as any postmarketing testing performed.

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 industry recruitment. The 2.1 percent increase in this faculty from 1999 to 2000 indicates that the talent pool is growing (Barzansky and Etzel, 2002). Because only 2 percent of research worldwide occurs within pharmaceutical companies (Yates, 2003), the private sector frequently collaborates with AHCs (and smaller companies) in conducting its clinical research. However, the majority of resident physicians-in-training do not receive formal exposure to research methods as part of their clinical development. Even fewer receive exposure to regulatory good clinical practice training, which is the core competency for clinicians working in industry (Martinez, 2003). Facing increasingly strained finances, academic institutions do not allocate sufficient resources to clinical research and the faculty necessary to carry it out well. In turn, the physician time devoted to clinical investigation or to experimenting with the development of novel healthcare delivery approaches has diminished (Snyderman, 2004). Lack of formal standardized training, appropriate certification, and adequate time for research are some of the limits placed on clinical researchers (Snyderman, 2004). Although the incentives offered by certifications and advanced research master’s and Ph.D. degrees should not be overstated. These incentives are not nearly as important as experience and exposure to these methodologies, which could be incorporated into the medical school curriculum. General clinical training could be made more accessible in a number of ways; for example, Web-based clinical research training programs could be offered so that continuous on-demand access would be available. Such programs could provide continuing medical education (CME) credits and course certification on good clinical practices (GCPs) and the processes of doing research. Starting and maintaining a research career demand a great deal from young physicians; the acquisition of additional degrees is not promoted (Martinez, 2003). To encourage physicians to pursue careers in clinical research, several pharmaceutical companies sponsor training in that research (examples are listed in Appendix H). Such training awards range from summer programs to postdoctoral training. Some fellowship programs are specifically targeted to disease areas. Information about these programs is not centrally located, and individual sponsors must be contacted for award eligibility details. THE SHORTAGE OF CLINICAL INVESTIGATORS In a trend that parallels the growing need for clinical study participants, a shortage of adequately trained clinical investigators may begin to

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 develop (Goldman and Marshall, 2002). One reason for this shortage lies in the complex and incompletely defined factors that are influencing the career choices of medical students. The many basic science; clinical care; and social, ethical, and economic issues addressed by today’s medical school curricula leave less time to educate students about the significance of biomedical research in bettering health care or to inspire students to participate in biomedical research. Exposure to research early in medical school training encourages involvement in and provides a basis for the student to pursue research training (Solomon et al., 2003). Five major obstacles dominate the clinical research landscape: Educational debt; Length of clinical research training time; Perceived challenges to recognition and promotion of clinical researchers; Inadequate training in clinical research techniques; and Increased regulations and monitoring of clinical research. At each stage of a clinical research career the associated obstacle can serve as a significant deterrent, or at least steer a potential researcher into a different career path; for example, the median debt among graduates of public and private medical schools is $70,000 and $100,000, respectively (Heinig et al., 1999). Before achieving independence, investigators may spend 5-10 postgraduate years in training (Wolf, 2002; Sung et al., 2003). Tenure and promotion standards may put investigators who conduct prolonged but noteworthy studies at an academic disadvantage. Significantly increased regulation and monitoring of clinical research can be found at many levels, including at the institutional (AHCs) level and at the federal level (such as at NIH), the Food and Drug Administration (FDA), and the Office for Human Research Protections (OHRP). Currently only 8 percent of principal investigators conducting industry-sponsored clinical trials are younger than 40 years, and data show inadequate numbers of new investigators to replace the older generation (Goldman and Marshall, 2002). Likewise, less than 4 percent of competing research grants awarded by NIH in 2001 were awarded to investigators aged 35 years or younger (Chan et al., 2002). In a survey assessing the health and quality of the clinical research enterprise as perceived by AHCs, 75 percent of respondents reported a moderate to large problem in recruiting clinical researchers who were

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 properly trained (Campbell et al., 2001). Two-thirds of respondents among the most research-intensive institutions reported difficulties in recruiting clinical researchers. The rest of this section discusses the reasons behind the specific shortages of physician-scientists, nurse-investigators, Ph.D.s in clinical research, and other investigators. Physician-Scientists The numbers of physician-scientists in the clinical research community are dwindling. A study by Newton and Grayson (2003) reviewing trends in career choice by graduates of U.S. medical schools found that there has been a decreased interest in research careers in both sexes. During the past decade, the percentage of U.S. M.D.s interested in exclusive or significant research careers has decreased by approximately 16 percent (AAMC, 2003). In 2002 only 0.9 percent of medical school graduates received combined M.D.-Ph.D. degrees, down from 2.3 percent five years earlier (NRMP, 2003). For future research in fields that integrate clinical and basic sciences, this trend has obvious implications (Newton and Grayson, 2003). Indeed, the academic medical community has become increasingly concerned about the challenges facing the clinical research enterprise in the United States. The survey by Campbell et al. (2001) found clinical research in academic health centers to be of poorer quality, less robust, and facing greater challenges than nonclinical basic research. The policies and mechanisms needed to address challenges facing the clinical research mission were not present at many AHCs. Of the AHCs that had such policies, more than half believed that those policies had not had large positive effects. The findings of the survey indicated that the infrastructure and workforce of clinical research might have to be strengthened and expanded to keep up with basic research advances. The sections that follow describe some of the deterrents to such an expansion: the debt burden faced by young M.D.s, physicians’ lack of success at obtaining research funding, physicians’ lack of mentors, and the disadvantages faced by physician-researchers in gaining promotions. Debt Burden Financial pressure may be a driving force in deterring physicians from clinical research careers (Wolf, 2002). Eighty-five percent of graduates of

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 medical school incur significant educational debt (Heinig et al., 1999; AAMC, 2003). According to the Association of American Medical Colleges (AAMC), since 1984 the median tuition and fees have increased by 165 percent in private medical schools and by 312 percent in public medical schools (AAMC, 2004a). In constant dollar terms, the increases have been 50 percent and 133 percent, respectively. From academic year 2002-2003 to 2003-2004, the median tuition and fees increased by 5.7 percent in private schools (3.4 percent in constant dollars) and 17.7 percent in public schools (15.1 percent in constant dollars). In six public medical schools the increases in tuition and fees exceeded 45 percent. It is not surprising then that today most clinical research physicians and dentists begin their professional careers with sizable educational debt (NRC, 2000). The average medical school debt of M.D. graduates increased more than 50 percent from 1990 to 1997, from almost $41,000 to just over $64,000, and reached an average of $102,000 in 2003.5 Research training and early career development add extra years, and additional financial pressure is put on all trainees, even those with minimal or no debt. Obtaining Research Funding Another deterrent to the entry and retention of physician-scientists in clinical research is their lack of sustained success in securing research funding (DePaolo and Leppert, 2002). In study sections in which both basic and clinical research grants are reviewed, clinical research applications fare less well in peer review than their basic science counterparts (Kotchen et al., 2004). The success rate for NIH research grants from 1996 through 2001 for first-time Ph.D. applicants was higher than that for first-time physician applicants, and the success rate for established investigators was higher than that for first-time applicants (Nathan and Wilson, 2003). M.D. applicant trends at NIH suggest that the research careers of many physicians end with the rejection of their first federal grant application (Wolf, 2002). Scarcity of Mentors One vital ingredient in the success of all physicians, including clinicians, basic scientists, and clinical researchers, is superior mentoring. Ideally, 5   See http://www.aamc.org/data/gq/allschoolsreports/2003.pdf. Date accessed December 5, 2004.

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 mentors direct trainees toward promising educational opportunities; they serve as advocates of trainees; and they lend expertise and funding to trainees’ mentor-guided studies. When asked to identify the most useful and positive aspects of their training, recent graduates of medical schools and training programs gave “outstanding mentorship” as their second most common response. The scarcity of experienced mentors and role models was often cited as a disincentive for entering a career in clinical research (AAMC, 1999). Today fewer capable mentors are available because fewer clinical researchers were trained in the past. Academic institutions’ mission to train the next generation of clinical scientists will erode if this trend is not reversed (Wolf, 2002). A study by Buckley et al. (2000a) found less time, less mentoring, and fewer resources for an academic career available to physician faculty who spent the majority of their time in clinical activities. Receiving Academic Promotions The promotion standards of academic institutions are uniform across all types of research, despite the slower pace of clinical research (Wolf, 2002). Investigators who choose to undertake essential but lengthy studies are at a disadvantage in receiving academic promotions as a consequence. Survey data reveal that the promotion standards for medical school faculty are centered primarily on research productivity (Beasley et al., 1997). For M.D. faculty with the rank of instructor and above in one institution, the adjusted odds of being satisfied with their progress at promotion were 61 percent lower among clinical researchers than among basic researchers (Thomas et al., 2004). For academic clinicians, the odds of satisfaction were 92 percent lower and for teacher-clinicians 87 percent lower. When academic clinicians and teacher-clinicians were compared with basic research faculty, the adjusted odds of being at a higher rank were found to be 85 percent lower for academic clinicians and 69 percent lower for teacher-clinicians. The lower growth of M.D.s funded in the clinical sciences by NIH compared with that of M.D.-Ph.D.s and Ph.D.s., together with the declining proportion of NIH award holders less than 45 years of age, indicate that the number of young physician-scientists will decline (Zemlo et al., 2000).

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 Nurse-Investigators It is estimated that by 2020 the United States will be experiencing a 29 percent deficit in nursing personnel (IOM, 2004b). This shortfall will have a particular impact on clinical research teams, which often rely on bedside nurses to collect data. The nursing profession has seen little growth in the number of underrepresented racial and ethnic minorities entering its ranks in recent years (IOM, 2004a). A recent study by Mateo and Smith (2003) of hospital-based nurses and diversity initiatives, outcomes, and issues related to patients and staff found that most respondents did not make management of diversity a priority for the workforce they were managing. In graduate nursing programs underrepresented minority students constituted 12.4 percent of students in master’s programs and 8.1 percent in doctorate programs (AACN and the National Organization of Nurse Practitioner Faculties, 2000). Among nursing graduates who were awarded degrees in 2002, White nurses constituted the largest percentage of graduates in baccalaureate, associate, diploma, and R.N. programs, earning between 60 percent and 70 percent of diploma, associate, basic B.S.N., and all basic R.N. degrees (National League for Nursing, 2003). In baccalaureate nursing programs underrepresented minority student enrollment increased by 48 percent between 1991 and 1999, from 11,661 to 17,303 baccalaureate nursing students (National League for Nursing, 2003). Of the U.S. nursing schools listed on the Nursing Spectrum Web site,6 the majority have a minority affairs office, a diversity center, or some other such entity to recruit and retain minority faculty and students, perhaps contributing to the increase in underrepresented minority student enrollment in baccalaureate nursing programs. Despite this development, underrepresented students, compared with the typical Caucasian or Asian students, are less likely to be enrolled in biological or life sciences or in health profession (nursing and other nonphysician) undergraduate programs (IOM, 2004b). The shortage of nurses stems from two factors, among others, described in the remainder of this section: (1) a diminishing nursing faculty and (2) an aging R.N. workforce. 6   See http://nsweb.nursingspectrum.com/Education/. Date accessed November 22, 2004.

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 Diminishing Nursing Faculty The growing deficit of full-time master’s and doctorally prepared nursing faculty is intensifying the overall nursing shortage. This lack of faculty is contributing to the current nursing shortage by curtailing the number of students admitted to nursing programs (AACN, 2003). A survey conducted by the American Association of Colleges of Nursing (AACN) found that 5,283 qualified applications to baccalaureate, master’s, and doctoral programs were rejected in 2002-2003 and that 41.7 percent of responding schools cited insufficient faculty as a reason for not accepting all qualified applicants (Berlin et al., 2003). In 2001-2002, of the 457 doctoral graduates 28.6 percent reported employment commitments in settings other than schools of nursing (Berlin et al., 2003). Data collected by the National Sample Survey of Registered Nurses for the years 1992, 1996, and 2000 showed a steady decline in the proportion of nurses with nursing doctorates who were employed in schools of nursing with baccalaureate and higher degrees, from 68 percent in 1992 to 49 percent in 2000 (Division of Nursing, 2001). Of those that complete graduate education, salary is an influential factor in employment decisions. The decisions of master’s-prepared nurses to return to doctoral study rest on calculations about whether it profits them to enter academia and seek doctoral study when they could earn higher salaries in nonacademic master’s-level positions (AACN, 2003). The pipeline from enrollees to graduates of doctoral programs in nursing schools is diminishing; in the fall of 2002 the 81 research-focused doctoral programs in nursing reported 3,168 enrollees and 457 graduates. Schools are not producing more graduates even though the number of doctoral programs increased from 54 in 1992 to 83 (including two clinic-focused programs) in 2002. Trends in master’s education should be of concern; in a five-year cohort of 289 schools reporting data each year, enrollments steadily declined from 1998 to 2001, followed by an increase of 898 students in 2002. Analysis indicated an average decrease of 110 students per year, despite this increase (Berlin et al., 2003). Master’s graduates are the source of future doctoral students and are a significant portion of current and future faculty (AACN, 2003). The Aging Workforce The growth in the number of R.N.s is being limited by declining enrollments in nursing schools and the aging of the R.N. workforce (IOM,

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 2004b). Since 1973 the percentage of college freshmen indicating nursing as a top career choice has dropped by 40 percent (IOM, 2004b). In 1983 the average age of the R.N. workforce was 37.4 (Buerhaus et al., 2000), but this average increased to 45.2 years in 2000 (Spratley et al., 2000). The seventh national sample survey of registered nurses in the United States revealed that in the two decades from 1980 to 2000, the percentage of nurses younger than 40 dropped from 52.9 percent in 1980 to 31.7 percent in 2000 (NRC, 2000; HRSA, 2003). Furthermore, the percentage of R.N.s younger than 30 dropped from 26 percent in 1980 to less than 10 percent in 2000. In 2000 four times as many 40-year-olds as 20-year-olds were nurses (IOM, 2004b). The average age of R.N.s is projected to increase and peak at 45.5 years in 2010 (Buerhaus et al., 2000). By contrast, the Department of Labor has forecast that the average age of the overall labor force will reach only 40.7 years by 2008 (Bureau of Labor Statistics, 1999). The projections by the Health Resources and Services Administration (HRSA) for the supply and demand of R.N.s between 2000 and 2020 predict a need for 750,000 more R.N.s than will be available (HRSA, 2002). If R.N.s are in short supply, doctorally trained nurses are growing particularly scarce. On average, they complete their degrees much later in life than do Ph.D.’s in other fields. Often this delay results from pursuing a Ph.D. part-time. Even those receiving National Research Service Award funds, which require full-time study, are generally over 40 by the time they finish their studies (Gordon et al., 2003; HRSA, 2003; McGivern, 2003). In 1999, of the 365 recipients of nursing doctoral degrees who reported their age, the median age was 46.2 years. Almost half of all graduates were between 45 and 54 years; twelve percent were older than 55; and 25 percent were younger than 35 (AACN, 2003). By comparison, the median age of all research doctoral awards in the United States was 33.7 years in 1999 (National Opinion Research Center, 2001). The median time that elapsed between entry into a master’s program to completion of the doctorate in nursing was almost twice that of other fields, 15.9 and 8.5 years, respectively (National Opinion Research Center, 2001). The advanced age of nursing Ph.D.s stems in part from the norms of the profession, which encourages its members to acquire considerable professional experience before seeking research training. Although this practice ensures professional expertise, later research training inevitably limits the length of an individual’s research career. The median age of nursing school faculty is now 50, and many nursing school deans report concerns about their abilities to replace retiring faculty (Gordon et al., 2003; HRSA, 2003; McGivern, 2003).

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 Ph.D.s in Clinical Research Ph.D.-trained scientists are now fulfilling a wide set of roles in medical education and research (Miller, 2001). As such, they are shouldering a significant portion of work within the clinical research enterprise. Ph.D.-trained faculty in clinical departments contribute substantially to teaching, especially during the first two years of medical school. Their contribution to the research conducted by the clinical departments to which they belong has also become significant. Moreover, through their collaborative and principal investigator efforts, they fulfill important mentoring roles for clinical research trainees. Undoubtedly these scientists will continue to be part of clinical departments, especially at research-intensive academic health centers. In this regard, leaders in the field have underscored the need for alternative career tracks for these faculty members, as well as greater job stability to compensate them for their contributions. Clinical research teams of the future will likely continue to draw on Ph.D.-trained researchers. The evaluation of clinical research training programs has been proposed in previous reports (IOM, 1994; NIH, 1997; Wolf, 2002). Other Investigators Of the approximate 4,000 dental graduates each year in the United States, 1.5 percent express interest in academia and less than 0.2 percent are interested in research (Juliano and Oxford, 2001; Stashenko et al., 2002). U.S. dental schools report challenges in filling academic positions (Stashenko et al., 2002). Efforts to increase interest in dental research early on as well as dental research training programs are needed. The shortage of pharmacists is a challenge as well for the clinical research enterprise. Federal pharmacy positions have experienced dramatically rising vacancy rates in recent years, reaching 11 percent in the U.S. Public Health Service and 15-18 percent in the armed forces (HRSA, 2000). In the late 1990s the number of pharmacy graduates declined, with a corresponding decline in the number of applications to pharmacy schools; in 1999 the number of applications was 33 percent lower than it had been in 1994, which was the past decade’s high point (HRSA, 2000). The demand for pharmaceutical care services has grown more rapidly in the past decade. Two major components of the increase in demand have become increasingly apparent, demonstrated by (1) the increased vacancy rates and difficulties in hiring, and (2) the demand for pharmaceutical care services

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 resulting from the increases in prescription drug volume and the expanded responsibilities and roles of today’s pharmacist (HRSA, 2000). FUTURE NEEDS A new model for training clinical investigators is emerging; formal clinical research training programs are replacing on-the-job training (Wolf, 2002; Zerhouni, 2003). Clinical research trainees must acquire specific expertise in study design, epidemiology, and biostatistics, to name a few areas (Wolf, 2002). They must also learn when and how to most effectively apply state-of-the-art techniques of clinical research, such as genomics and proteomics. Furthermore, they must be trained in those issues that pertain specifically to research involving human subjects, such as the principles of informed consent and human safety protection. The complex nature of clinical research requires a team approach in which investigators interact with their team members across disciplines and geographical locations. Because of the past and present state of the clinical research workforce, proactive steps are needed to develop new paradigms for a diverse and capable clinical research workforce that meets the needs of twenty-first-century medicine. As the complexity and volume of research in the life sciences have increased, groups of various investigators have tended to pool together to tackle complex problems (Drenth, 1998; Cheung et al., 2001; HRSA, 2002; Collins et al., 2003). The future will see the need for more such research teams and thus the need to promote all the potential players of the clinical research enterprise.