4
Training Pathways

A generation ago medical research was conducted largely by physicians, most of whom had little formal training in science (Smith, 1989). Clinical investigation was focused on disease and disease processes and was conducted largely at the patient level. Advances in cell biology and molecular genetics are bringing investigators closer to discovering how genes direct and influence normal human development as well as disease. Developments in areas such as neurobiology, immunology, and developmental biology present new challenges for designing and testing innovative treatments and preventions. Furthermore, new methodologies for assessing the outcomes of current and new medical technologies are evolving rapidly. Rigorous clinical research training is required to ensure valid results, inferences, and conclusions to improve health care practices. Yet, there is a growing concern that too few people are being trained to conduct sophisticated studies on the advances presented by these new developments in science and technology (Kelley, 1988; Martin, 1991).

Numerous criticisms have been leveled at the U.S. system of undergraduate and graduate medical education, including a growing divergence between patient needs and physician training; excessive emphasis on research and service in research-intensive universities at the expense of teaching; poor integration between the preclinical and clinical components of medical education; changes in hospital-based clinical training and the move to more ambulatory care, as a result of which trainees are unable to observe the entire course of disease; and a teaching style that fails to engender the development of faculty role models or imbue students with problem-solving skills and positive attitudes for lifelong learning (Cantor et al., 1991; Goodman et al., 1991). Moreover, along with the growing



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Careers in Clinical Research: Obstacles and Opportunities 4 Training Pathways A generation ago medical research was conducted largely by physicians, most of whom had little formal training in science (Smith, 1989). Clinical investigation was focused on disease and disease processes and was conducted largely at the patient level. Advances in cell biology and molecular genetics are bringing investigators closer to discovering how genes direct and influence normal human development as well as disease. Developments in areas such as neurobiology, immunology, and developmental biology present new challenges for designing and testing innovative treatments and preventions. Furthermore, new methodologies for assessing the outcomes of current and new medical technologies are evolving rapidly. Rigorous clinical research training is required to ensure valid results, inferences, and conclusions to improve health care practices. Yet, there is a growing concern that too few people are being trained to conduct sophisticated studies on the advances presented by these new developments in science and technology (Kelley, 1988; Martin, 1991). Numerous criticisms have been leveled at the U.S. system of undergraduate and graduate medical education, including a growing divergence between patient needs and physician training; excessive emphasis on research and service in research-intensive universities at the expense of teaching; poor integration between the preclinical and clinical components of medical education; changes in hospital-based clinical training and the move to more ambulatory care, as a result of which trainees are unable to observe the entire course of disease; and a teaching style that fails to engender the development of faculty role models or imbue students with problem-solving skills and positive attitudes for lifelong learning (Cantor et al., 1991; Goodman et al., 1991). Moreover, along with the growing

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Careers in Clinical Research: Obstacles and Opportunities complexities of the U.S. health care system and its burgeoning problems, medical students are expected to become increasingly compassionate and caring as well as more aware and knowledgeable about patients' insurance coverage, case law, and ethics. Dentistry, nursing, and other health professional groups also encounter barriers to clinical research careers that may or may not be similar to the barriers found in medicine. For example, unlike medicine, where there is extensive graduate medical education, the dental school curriculum is designed to prepare dentists who can practice dentistry upon graduation—after four years of graduate education. The dentistry curriculum thus combines didactic course work and clinical skills development during those four years, which brings into question the amount of time that dental students can commit to developing research skills (Appendix A). Although nurses, pharmacists, and allied health professionals generally acquire their clinical practice skills at the undergraduate level, most acquire their research skills in doctoral programs. In the past, many of these doctoral programs have been in other fields, such as education or psychology. New doctoral programs in nursing and allied health disciplines are being created, however (Appendix B; Selker, 1994). The committee did not have the expertise to judge the effectiveness or the quality of programs in dentistry, nursing, and the allied health professions. The committee therefore sought input from the appropriate professional groups through task forces, commissioned papers, or written comments. Most groups felt that there were obstacles in the training pathways leading to careers in patient-oriented clinical research. Some of these were seen as peculiar to a given profession, whereas others were viewed as generic to all health care groups. The complete task force reports on dentistry and on nursing and clinical psychology can be found in Appendixes A and B, respectively, and the background paper by Dr. Selker elaborates on clinical research in the allied health professions (1994). Where appropriate, however, the concerns of those groups will be noted in the text. The committee believes that health care professionals in all fields should be well-versed in the sciences underpinning the practice of health care. Sophisticated scientific and quantitative preparation empowers health care practitioners to pose insightful questions about human biology and behavior, to retrieve and critically analyze information for use in solving clinical problems, and to remain open to unexpected new possibilities. The diverse responsibilities in the various professional groups engaged in clinical research require that they have different kinds and levels of educational and scientific backgrounds. Unlike doctoral programs, in which the goal is to train highly skilled research scientists, the primary goal of health professional schools is to blend the scientific knowledge base with clinical skills to prepare highly qualified and competent practitioners of health care. In a health care environment in which health care knowledge and technology are accelerating rapidly and new discoveries are reported almost daily,

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Careers in Clinical Research: Obstacles and Opportunities preparing health practitioners who are well-grounded in the biological, social, behavioral, information, and quantitative sciences becomes ever more challenging. Clearly, all health care professionals should have a firm grasp of the traditional biomedical sciences as well as the social and behavioral sciences (Association of American Medical Schools, 1992b; Greenlick, 1992). Newer interdisciplinary biological sciences such as molecular biology, molecular genetics, and neuroscience, as well as increasingly sophisticated quantitative methods in areas such as medical effectiveness research, are also expanding the boundaries of knowledge for health care. To begin to analyze the many perceived obstacles in the pathways leading to clinical research careers at the professional school level, the committee posed several generic questions: Is the present system for clinical research training inadequate? What does society want and expect students to know? Are professional schools organized to meet these goals? Are the faculty and administration committed to change? Are resources available for effecting change where changes are needed? To approach these questions, the committee developed a list of issues that were addressed by the subcommittees examining issues affecting clinical research careers in the precollege and undergraduate periods, during graduate education, and during postdoctoral training. The committee examined the recruitment into scientific careers and the retention of those interested in pursuing research careers. Clearly, issues that affect students early are the quality and quantity of hands-on research experiences that are directly related to resources and quality of teaching. If students are unprepared or ''turned off" to science and mathematics early in the educational process (that is, during their education from kindergarten through grade 12 [K–12]), should mechanisms be developed to change the environment and inspire interest in these fields? The influence of role models and mentors throughout the education and training pathway also have an effect on decisions to pursue scientific careers (Cameron, 1991). As students move into college, some of the same factors concerning quality of scientific curricula apply, but other factors can also affect their career choices, including income potential, job availability and security, and economic factors. Extensive length of training, accumulating educational debt, absence of quality research experiences and funding for research training, lack of time for engaging in research activities, lack of effective mentoring, and other lifestyle factors are some of the factors confronting health professionals who are interested in graduate education and postgraduate training (Applegate 1990; Smith, 1989). Furthermore, the demographics of the United States are changing, and the committee recognizes that changes in the education and training environment must be sensitive to gender and cultural differences and encourage increasing numbers of these groups to pursue research

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Careers in Clinical Research: Obstacles and Opportunities careers. Thus, this chapter examines the barriers and obstacles to research careers throughout the education and training pathway. Many of the issues confronting individuals are generic to all scientific careers, while some are specific to clinical research careers. The distinctions will be noted where applicable. It should be noted, however, that the committee has been hindered in its analyses by the extreme lack of outcomes data for research training programs and for factors affecting career choice. Although the audience for this report might question the relevance of K–12 science experiences and their relationship to clinical research careers, the committee felt that it was important to reemphasize obstacles throughout the entire education and training pathways for clinical investigators. All too often, reports of this nature focus too narrowly on the late stages of training and neglect the earlier stages of education that influence the pool from which scientific talent will be drawn. Because each successive level of the training pathway relies on the preparation of the talent pool of the previous level, the committee felt that it would be productive to examine obstacles to scientific careers, particularly clinical investigative careers, from kindergarten to the achievement of a career as an established scientist. The first portion of this chapter presents an overview of existing efforts to stimulate interest in careers in the sciences and health professions among students of all ages. Particular attention is paid to activities that involve or encourage students to become interested in scientific investigation. Because the committee membership did not have professional educators at the K–12 levels or at the undergraduate level, they chose to draw upon the work of others who have considered this issue. Among the sources relied on were Educating Scientists and Engineers: Grade School to Grad School (U.S. Congress, Office of Technology Assessment, 1988a); Nurturing Scientific Talent: A Discussion Paper (National Academy of Sciences, Government-University-Industry Research Roundtable, 1987); Fulfilling the Promise: Biology Education in the Nation's Schools (National Research Council, 1990); and By the Year 2000; First in the World (Federal Coordinating Committee for Science, Engineering and Technology, Committee on Education and Human Resources, 1991). To supplement these sources, the committee commissioned a paper by Marcia Matyas formerly of the American Association for the Advancement of Science, "Early Exposure to Research: Opportunities and Effects" (Matyas, 1994) from which this section of the report draws heavily. The following sections of the chapter closely examine what is known, or not known, about professional education and training for careers in clinical investigation. These sections are supplemented by excerpts from the workshop "Clinical Research and Research Training: Spotlight on Funding" (Appendix D) the task force reports (Appendixes A, B, and C), and commissioned papers on training programs of the National Institutes of Health (NIH), models for

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Careers in Clinical Research: Obstacles and Opportunities postdoctoral clinical research training, the influence of resident review committees and certification boards on research training, and mentoring. DEMOGRAPHICS The committee recognizes that the recruitment and retention of scientists and health professionals into careers as clinical investigators must reflect the changing demographics of the United States (U.S. Congress, Office of Technology Assessment, 1985). Unlike nursing, which has been dominated by women, scientists and academic physicians in the past have characteristically been white males. Women now constitute nearly half of all medical students in U.S. medical schools and earn slightly more than a third of all life sciences doctorates (National Research Council, 1987b, 1991). The picture is not as hopeful for African-Americans, Hispanics, and native Americans, who remain underrepresented in research and medicine (National Research Council, 1987a). This is of considerable concern because by the turn of the century, one third of the children living in the United States will be members of minority groups. These demographic data indicate that special efforts are needed to recruit members of these groups to pursue careers in patient-oriented clinical research (Robert Wood Johnson Foundation, 1987). KINDERGARTEN TO COLLEGE The decision to pursue a career in the sciences or health professions is the result of the interaction of many educational, psychosocial, and environmental factors. Exposure to science and mathematics instruction beginning in elementary school profoundly influences career choice (Federal Coordinating Council on Science, Engineering and Technology, 1991). Most commonly, school-age children get their first exposure to science by conducting hands-on experiments in the classroom. Other factors not directly related to the formal educational process are important as well. For example, many decisions to pursue a career in the sciences are the result of personal characteristics, such as positive motivation and good study habits. The expectations of parents, teachers, and peers; adequate mentoring; the presence of career opportunities; good occupational status; and job security also clearly play a role. Students can also be influenced by their participation in informal science experiences offered through museums or youth clubs (Matyas and Malcom, 1991). The committee believes that life experiences and the quality of science education during the formative years have a profound effect on the future talent pool from which highly capable clinical investigators will be drawn at later stages of the education pathway.

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Careers in Clinical Research: Obstacles and Opportunities Classroom Experience There are some 45 million students and 2.5 million teachers in the nation's 60,000 public and 40,000 private elementary and secondary schools. Because of the diversity of schools, school districts, and local control over education, the quality and effectiveness of science and mathematics education can be equally diverse. With the exception of a few magnet science high schools with the stated goal of fostering greater interest in scientific careers, most schools and school districts cannot or do not emphasize one subject area over another. Although hands-on science activities are an ideal way to stimulate student interest in science, for a variety of reasons, many students are not introduced to these kinds of science experiences. For one thing, most students have only minimal exposure to science-related instruction. According to one national survey of teachers, an average of only 18 minutes a day is devoted to science in grades kindergarten–3; in grades 4–6, the average exposure is 29 minutes (Weiss et al., 1989). Far more time is spent teaching mathematics and reading. When hands-on or laboratory activities are used in the classroom, they are seldom truly experimental. More typically they are "cookbook" activities, with prescribed outcomes designed to illustrate specific phenomena. Students rarely have the chance to develop their own hypotheses, design and execute experiments, and draw conclusions. Teachers are probably the most critical ingredient in a young person's education. Good teaching can inspire students and foster intellectual pursuits by promoting interest in the subject matter, comprehension, and perseverance. Poor teaching can stifle learning, leading to student disinterest and complacency. According to the Federal Coordinating Council on Science, Engineering and Technology (FCCSET) Committee on Education and Human Resources (1991), less than one third of the nation's elementary, middle school, and high school math and science teachers meet coursework standards established by their own professional organizations. Elementary school teachers often are expected to teach science and mathematics, yet they have taken little or no course work in these subjects. High school math and science teachers are less likely, on average, than teachers in other fields to have concentrated in their primary teaching field during college (Federal Coordinating Council on Science, Engineering and Technology, 1991). As a group, teachers at each grade level are more likely to rely on didactic methods than hands-on experimentation, small-group problem-solving, or demonstrations. Not only is it difficult to recruit highly talented teachers with science backgrounds but it is also difficult to retain the highly skilled teachers already in the system. Although teacher salaries grew nearly 25 percent in real terms from 1983 to 1988, budget cutbacks at the federal, state, and local levels over the past few years have forced many public school teachers to forgo salary raises or even to take reductions in compensation and benefits. It has been estimated that for

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Careers in Clinical Research: Obstacles and Opportunities every science or math teacher entering teaching for the first time, 13 leave the profession (Federal Coordinating Council on Science, Engineering and Technology, 1991). Educational quality also is heavily dependent on the availability of resources—including not only money but also up-to-date texts and instructional materials. Teacher morale declines as these professionals are asked to do more with increasingly inadequate resources and outdated instructional materials. Furthermore, most schools do not have adequate equipment or facilities to allow routine laboratory experimentation. This is especially true in elementary and middle schools. For K–12 teachers, inadequate facilities, lack of materials for individualized instruction, and insufficient funds for purchasing equipment and supplies were among the problems most often cited as "serious" impediments to teaching science. Science Fairs and Competitions In contrast to the classroom experience, science fairs and competitions often provide valuable exposure to research. Although many science fairs accept nonexperimental projects, it is becoming increasingly common to require students to conduct background research, develop a hypothesis, and conduct a series of experiments to prove or disprove the hypothesis. The International Science and Engineering Fair and the Westinghouse Talent Search are among the largest such initiatives in the United States.1 Another forum for student involvement in research is the American Junior Academy of Science, which allows high school students to present their research at the annual meeting of the American Association for the Advancement of Science. Publications such as the Journal of High School Science Research and the Journal of Student Research provide high school students with the opportunity to publish their studies. Although these programs and activities involve thousands of students each year, their focus is almost exclusively on high school students. Despite this progress, the majority of U.S. students finish their precollege years without having had a significant research experience (Matyas and Malcom, 1991). For many precollege students, the primary opportunity to engage in hands-on science activities comes through informal experiences, such as visits to science museums, or participation in youth organizations, such as Boy Scouts of the USA, Girl Scouts of the USA, Girls, Inc. (formerly Girls Clubs of America, Inc.), and church groups (Matyas and Malcom, 1991). Parents can also facilitate 1   Both the International Science and Engineering Fair and the Westinghouse Talent Search are conducted through Science Service, Inc., Washington, D.C.

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Careers in Clinical Research: Obstacles and Opportunities TABLE 4-1 Science Classroom Activities Used by Teachers During Their Most Recent Science Lesson by Grade Level, 1985–1986   Percentage of Classes   Science Classroom Activity K–6 7–9 10–12 Lecture Discussion Demonstrations Hands-on or laboratory materials Use of computers Working in small groups Doing seat work from textbook Completing supplemental work sheets Assigning homework 74 87 52 51 2 33 31 38 28 83 82 42 43 5 35 45 44 54 84 80 44 39 5 36 35 37 52   Source: Weiss, 1987. these activities at home by providing toys and materials that encourage exploration and experimentation. Specific Initiatives A number of programs have been designed to give precollege students experience with hands-on, inquiry-based science. A few engage students in actual research projects (Table 4-1). For the most part, programs that involve students in research are targeted at the high school level and reach limited numbers of students. Student research experiences also can be indirectly affected by programs aimed at improving the science literacy of teachers and parents. In-service programs, for example, can help teachers acquire knowledge of content and teaching methods to incorporate laboratory components into the science curriculum. Workshops can inform teachers and parents about research opportunities that allow children to become involved, either directly with an individual researcher or through a formal program.

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Careers in Clinical Research: Obstacles and Opportunities Effecting Change On the positive side, there is evidence that science and mathematics education is receiving increasing attention by policymakers at many levels. Among the goals established in 1989 by the nation's governors for improving the U.S. educational system, for example, was that U.S. students become first in the world in science and mathematics achievement by the year 2000 (Federal Coordinating Committee for Science, Engineering, and Technology, 1991). Subsequently, the FCCSET established strategic objectives for improving students' preparation in the sciences and mathematics. Concern about a future shortage of scientists and engineers has spurred expanded federal investment in an effort to increase student interest in science, mathematics, and engineering. In fiscal year 1992, federal agencies participating in the FCCSET Committee on Education and Human Resources2 requested that nearly $180 million be spent on student opportunities and incentives. This reflects a 56 percent increase over 1990 budget levels. An additional $100.5 million was requested by the Department of Defense for Reserve Officers' Training Corps scholarships, many of which go to students majoring in science or engineering. It is difficult to estimate the level of financial commitment to science education by colleges, universities, industry, and professional societies. It is the committee's sense, however, that there has been an overall increase in both funding for and activities related to enhancing precollege science education. Federal Programs Certain federal agencies offer students the chance to gain research experience through summer apprenticeship programs. These programs usually enroll students in grades 10 through 12. A number of agencies conduct Saturday academy programs, which run during the academic year. The NIH's Biomedical Research Assistant Saturday Scholars program, for example, involves 90 junior and senior high school students in hands-on laboratory activities on Saturday mornings. NIH has also initiated a new program called the Science Education Partnership program to encourage careers in the biomedical sciences. The National Oceanic and Atmospheric Administration also sponsors a Saturday academy for junior and senior high school students (Matyas, 1994). 2   FCCSET includes the Departments of Agriculture, Commerce, Defense, Education, Energy, Health and Human Services, Housing and Urban Development, Interior, Justice, Labor, Transportation, and Veterans Affairs and the Environmental Protection Agency, National Aeronautics and Space Administration, National Science Foundation, Smithsonian Institution, and Barry M. Goldwater Foundation.

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Careers in Clinical Research: Obstacles and Opportunities A new NIH program, the Biomedical Preparatory School, gives high school students course credits for time spent in agency laboratories. Under the U.S. Department of Defense's Junior Science and Humanities Program, some 10,000 high school students annually participate in regional meetings where they present their research findings. The National Science Foundation's (NSF's) Young Scholars Program, which targets minority students, lets students work side by side with researchers (National Science Foundation, 1990). In 1992, approximately 8,000 students participated in the program. NSF also encourages minority student involvement in research through its Summer Science Camps and Comprehensive Regional Centers for Minorities. Nonfederal Programs There is also a significant nonfederal attempt to provide research experiences to precollege students. The 1992 Directory of Student Science Training Programs for Precollege Students lists 428 such programs, almost all of which are implemented at or by colleges and universities (Science Service, Inc., 1991). A small number of programs are hosted by science museums; industrial and professional societies participate only rarely in such efforts. Summary Although some attempts are being made to increase students' interest in science and mathematics, current initiatives fall short in a number of respects. Most science education efforts function more to retain students already in the science career pipeline than to recruit new entrants. In general, the younger the student, the less intensive the research experience is likely to be. The number of students who participate in such activities is relatively small compared with the number of students at the early high school level who are interested in a science or engineering career. In 1977, among 7 million high school sophomores, roughly 730,000 expressed an interest in a future career in science or engineering. The kinds of programs described here, however, have the capacity to serve less than one third of these students. To tap into the larger pool of interested students, additional ways of involving students in research activities are needed, as is greater involvement of the public and private scientific communities.

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Careers in Clinical Research: Obstacles and Opportunities RESEARCH EXPERIENCES FOR UNDERGRADUATE STUDENTS In many respects, undergraduate education and training in the United States rival or surpass those of comparable educational systems in most other countries around the globe. The U.S. research enterprise, which depends heavily on the flow of talented undergraduates into academic and industrial laboratories, is also one of the strongest in the world. For all of its strengths, however, U.S. higher education, particularly in the sciences, is facing numerous challenges. Rising tuition costs, for example, present significant barriers for many high school students hoping to enroll in college. Of particular concern, however, is that students who do gain entry into the higher education system appear to be showing less and less interest in studying science and mathematics (U.S. Department of Education, Office of Educational Research and Improvement, 1991; Lapoint et al. 1989). The proportion of college freshmen planning to major in the two subjects dropped by half between 1966 and 1988, from 11.5 to 5.8 percent (Green, 1989). There is also evidence of considerable attrition into other fields among undergraduates who initially show an interest in the sciences (Hewitt and Seymour, 1991). Although 70 percent of business majors and more than 60 percent of education and social science majors earned their baccalaureate degrees in four years (Cooperative Institutional Research Program, 1982), fewer than 40 percent of students initially majoring in biology received their degrees; the remainder either obtained non-science degrees or dropped out of college. The committee believes that few, if any, students who are turned off to science at the time they enter college will pursue research careers. At the undergraduate level, it is government and academia that are most involved in encouraging student involvement in science. To a lesser extent, professional societies encourage student interest in science-related studies through scholarship and research internships. Industry supports student research activities through scholarships and cooperative and summer internship programs. Most industry-supported programs, however, target students interested in engineering and the physical sciences rather than the life sciences (Matyas and Malcom, 1991). Institutional Programs Academic institutions are strong sponsors of student involvement in research. Often these efforts are part of the regular curriculum. For example, many liberal arts colleges require students to conduct a research project as part of their graduation requirements. Some institutions have programs specifically intended to encourage student participation in ongoing faculty research projects.

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Careers in Clinical Research: Obstacles and Opportunities to the individual K11 awards, NIH supports an Institutional Physician-Scientist Award, the K12 award. The K awards are heterogeneous in many respects, including the amount of research training expected. To date there has been very little evaluation of these transitional training-research mechanisms, particularly with regard to patient-oriented research (Biddle et al., 1988; Carter et al., 1987). NIH has plans to collect systematic information about program similarities and differences as a precursor to developing more comprehensive evaluation efforts. In 1991, $99 million was allocated for all individual career development awards (CDAs). Of this, about $4.3 million supported 66 M.D. recipients of K04 awards, $38.7 million supported 499 M.D. recipients of K08 awards, and $24.4 million supported 306 Physician-Scientist Awards (K11 awards). An additional $4.9 million was awarded for Institutional Physician-Scientist Awards (K12 awards). Some trends for the K awards are noteworthy. On the one hand, the K04 awards, which required previous research experiences, have declined by more than half over the past 10 years, from 787 in 1982 to 313 in 1992. On the other hand, the number of Clinical Investigator Awards (K08 awards) grew from 160 to 527 over the same period, and the number of K11 awards, initiated in 1984, grew to 321. As with all of the preceding grant and training program data, accurate data on the amount of patient-oriented studies supported through K awards are difficult to uncover. About 40 to 45 percent of K award applications indicate the intent to use human materials or human subjects; this percentage is consistently a few percentage points higher than that for the application pool for regular research grants (R01 awards). Ahrens has performed analyses on a sample of 243 abstracts from Physician-Scientist Awards to determine the fraction that are patient-oriented. He concluded that about 30 percent included some research involving humans (Ahrens, 1992). Clinical Associate Physician Program Although any of above training programs could be used by trainees pursuing a career in patient-oriented research, the only awards specifically designed to foster this type of investigation are those supported through the Clinical Associate Physician (CAP) program. CAP awards are funded by the General Clinical Research Center branch of the National Center for Research Resources (see Chapter 3 for a description of the General Clinical Research Center program). Each center is allowed a maximum of two CAPs. Recently, the training period has been extended from two to three years. Since the program's inception in 1974, more than 260 clinical investigators have been trained through the CAP program. About 40 new CAP awards are made each year (Figure 4-13).

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Careers in Clinical Research: Obstacles and Opportunities FIGURE 4-13 Number of clinical associate physician (CAP) fellows supported annually by the General Clinical Research Center program and the amount of funding, 1983–1992. (Source: National Center for Research Resources.) Preliminary results from an ongoing analysis of the CAP program demonstrate that the CAP alumni are successful in obtaining subsequent funding from NIH. More than 40 percent of the physicians in the CAP program have received NIH funding as principal investigators. Similar numbers of K08 award recipients are successful in obtaining funding. An unknown number are probably involved in research as coinvestigators, but that number has not been determined. A survey of the clinical associate physicians is under way and should reveal how many are actually involved in NIH-sponsored research and receive funding from other sources. Given the nature of the program, it is likely that a high percentage of those funded are actively involved in patient-related clinical research. These results indicate that the CAP program and the K08 award program are effective in training competitive clinical investigators.

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Careers in Clinical Research: Obstacles and Opportunities Non-NIH Federal Support Although NIH is the major supporter of health-related training, including that targeted at training patient-oriented researchers, there are several other federal sponsors of health-related training. For example, prior to its reorganization and incorporation into NIH, the National Institute of Mental Health, the National Institute of Drug Abuse, and the National Institute of Alcoholism and Alcohol Abuse supported about 1,500 NRSA fellowships and traineeships (pre- and postdoctoral) totaling $32.9 million in fiscal year 1990 (Alcohol, Drug Abuse, and Mental Health Administration, 1991). Specific research training opportunities in health services research are supported by the Agency for Health Care Policy and Research (AHCPR), primarily in the form of dissertation awards and individual and institutional postdoctoral training awards. In fiscal 1992, AHCPR invested about $3 million in training through NRSA fellowships and traineeships—equal to only about 1 percent of NIH allocations for training. The U.S. Department of Veteran's Affairs also has a small program of research training efforts in this area. Postdoctoral training for physicians who are pursuing a master's degree in public health is available for individuals who are interested in health care delivery research questions relevant to the services provided by the U.S. Department of Veteran's Affairs. Since 1951, the Centers for Disease Control and Prevention has sponsored a combined training and service epidemiology training program for postdoctoral training, the Epidemic Intelligence Service. Working under the supervision of practicing epidemiologists at the various Centers for Disease Control and Prevention sites, trainees develop their epidemiologic skills during a two-year fellowship. Although the program focuses on preparing trainees with epidemiologic skills to work in public health, it also encourages active participation in population research. More than 1,700 professionals have served in the Epidemic Intelligence Service. About 80 percent of the participants are physicians; other health professionals such as nurses and dentists with master's degrees in public health are also accepted into the program. One interesting aspect of the program is that the American Board of Preventive Medicine recognizes the training program fulfills the certification requirements of one-year of supervised training and field experience. Many of the alumni are employed in public health agencies, including the Centers for Disease Control and Prevention; about 12 percent are on university faculty (Thacker et al., 1990). Whereas the program may be effective in training public health epidemiologists, it might serve as a model for patient-oriented clinical research. The Food and Drug Administration also has developed an extensive intramural program for training Food and Drug Administration staff. For example, the Center for Drug Evaluation and Research operates a staff college that helps to train its medical reviewers. Enrollees can take courses in drug law and

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Careers in Clinical Research: Obstacles and Opportunities regulatory procedures, basic and applied statistical methods, chemistry and biotechnology, immunology, pharmacology, and clinical trials (U.S. Department of Health and Human Services, Food and Drug Administration, 1992; Peck 1988). Effectiveness of these types of programs in preparing clinical investigators, rather than train individuals to assess regulatory requirements for new drugs and devices, is not known. Private Support There is no current, comprehensive source of information about private sources of funding for clinical research training. A 1983 report by the Rand Corporation listed 75 foundations that provided some support for training physicians and as well as those with Ph.D.s (Carter, 1983). In 1981, according to the report, foundations funded some 400 individual junior faculty and postdoctoral awards for M.D.s. These numbers are certainly out of date, although it is not known whether they under- or overestimate the present level of funding. Non-federally supported M.D.-Ph.D. programs may be supporting as many as 700 double-degree candidates, although this number also cannot be verified (Ahrens, 1992). Informal contacts with several voluntary health agencies and foundations by Institute of Medicine staff revealed that many support training, particularly of M.D.s. When queried whether their training programs specifically support patient-oriented clinical research trainees, most responded that they did not. Exceptions to this are the American Cancer Society, which recently started a junior faculty program for human investigation training, and the American Heart Association, which has an equally broad set of training programs. More frequently, these organizations and foundations support fundamental research training pertaining to their specific missions. Some medical specialty groups have taken research training into their own hands. The Orthopaedic Research and Education Foundation (supported by individual contributions of members of the American Academy of Orthopaedic Surgeons and the Orthopaedic Research Society), for example, raised $3.8 million in 1991, nearly all of which went to fund peer-reviewed research and research training activities (Orthopaedic Research and Education Foundation, 1991). Again, it is not clear how much of these training funds is used to support patient-oriented clinical research training. Health policy and health services research training are promoted by several private foundations. For example, the Robert Wood Johnson Foundation funds a Clinical Scholars Program, which has trained postdoctoral physicians in health services research since 1969 (Piccirillo, 1992; Shuster et al., 1983). Predoctoral and postdoctoral training are also supported by the Pew Charitable Trusts and Harvard Medical School's Clinical Effectiveness Program, the latter funded by the

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Careers in Clinical Research: Obstacles and Opportunities Kellogg Foundation, the Klingenstein Fund, NIH, and the Health Resources and Services Administration (Goldman et al., 1990). Payback of Debt As mentioned previously, many medical residents accrue a large amount of education-related debt from undergraduate and medical schools. Under the current rules, payback must begin in the third year of postgraduate training. To accommodate this financial burden, research training often is either omitted to facilitate earlier entry into practice or is used as a time to moonlight to earn money for debt repayment. Neither scenario is likely to permit adequate or high-quality training for research on human subjects. Other than established training programs that pay stipends during research training, some novel programs are focusing on mechanisms to repay educational debt and retain trainees. One notable example is the NIH program for AIDS researchers begun in 1989. In this program, physician research trainees are recruited to NIH to engage in AIDS research. Trainees are encouraged by the opportunity to relieve their educational debt load. NIH allows $20,000 in debt relief for each year served to a maximum of $40,000. In addition, the trainees are paid a stipend for living costs. In the first three years this program was under way, 19 trainees were accepted into the program each year. Although this is a promising avenue for encouraging ongoing participation in research, it is not evident how many of these trainees are actually engaging in patient-oriented research. Moreover, this is small program in an area of great need. It is too early for the program to have any measurable outcomes for continued participation rates in research. Federal programs such as those described above require authorization through public law. The NIH Revitalization Act of 1993 expanded this opportunity to other areas at the discretion of the NIH director (U.S. Congress, 1993). MODEL PROGRAMS FOR RESEARCH TRAINING Although many of the methodologic advances in patient-oriented research have been developed in graduate schools of public health and divisions of general medicine, investigators in subspecialties of medicine and other departments are increasingly recognizing the need for training in these techniques (Goldman, 1991; Goldman et al., 1986). This trend is the reflection of a paradigm shift in which new ''horizontal" relationships are formed within a medical center, crossing the "vertical" divisions defined by preclinical sciences and clinical specialties and subspecialties (Kelley, 1992). These horizontal relationships may be defined by diseases, such as cancer, or by research methodologies. At many universities

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Careers in Clinical Research: Obstacles and Opportunities molecular biologists have developed informal or formal research interactions that play more active day-to-day roles in their lives than interactions with their subspecialties do. The same kind of cross-disciplinary associations are developing among investigators interested in advanced patient-oriented research methodologies. A number of programs have been initiated around the country to provide investigators with the skills needed to perform patient-oriented research. A selection of these is described below; this is followed by a discussion of some of the characteristics common to most such initiatives. Overview of Selected Programs Robert Wood Johnson Clinical Scholars Program One of the oldest, largest, and most successful of the existing research training programs is the Clinical Scholars Program (CSP) (Shuster et al., 1983), which was started in 1969 by the Commonwealth Fund and Carnegie Corporation. Since 1973, CSP has been funded by the Robert Wood Johnson Foundation. Each year some 25 new fellows are enrolled in six programs at seven universities and their affiliated Veterans Affairs Hospitals. The foundation does not encourage the pursuit of advanced degrees. From 1971 through 1992 there were 600 graduates of CSP, of whom 363 (61 percent) are currently in academic medicine and another 31 (5 percent) are in government. Slightly more than half of the graduates were from internal medicine. Many have assumed leadership roles at their institutions and at various federal agencies, including AHCPR. University of Michigan School of Public Health The University of Michigan School of Public Health supports a program in clinical research design and statistical analyses that can lead to a master's of science degree (Penchanksy et al., 1988). The program's required core courses are taught during 18 sessions, each of which is held about once a month and lasts for four days. Student participants include physicians at various levels of training and other health care personnel. Harvard Clinical Effectiveness Program The Harvard Clinical Effectiveness Program provides methodologic training to postdoctoral trainees during an intensive two-month summer session

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Careers in Clinical Research: Obstacles and Opportunities administered by the Harvard School of Public Health (Goldman et al., 1990). The program was initiated in 1986 in response to interest generated among medical subspecialty fellows supported by NIH training grants. The curriculum provides 15 credits (of the 40 needed for a master's of science or master's of public health degree) at the Harvard School of Public Health. During this period, fellows are required to be completely free of clinical responsibilities. A prerequisite for all applicants for the program is a commitment to an academic career that will utilize the methodologic skills taught in the program. All applicants must be sponsored by the chief of their clinical subspecialty division or department, who must pay the trainee's tuition (currently about $6,000) with individual or institutional training grants or other institutional funds. Of the 80 physicians who have enrolled in the summer curriculum and who have finished their clinical training, 68 (85 percent) hold full-time academic positions and another 4 (5 percent) are in government or nonprofit research positions. Other Programs Among other academic centers that sponsor patient-oriented research training programs are those at Johns Hopkins University, the Mayo Clinic, Stanford University, the University of California at San Francisco, and McMaster University in Canada (Neufield, 1989). Common Characteristics In most instances, the programs are coadministered by schools of public health and departments of medicine. Several programs are affiliated with degree-granting schools of public health; others actively involve divisions of epidemiology and biostatistics within the medical school. Strong emphasis is placed on issues of study design such as formulation of the research question, types of study design, subject selection, randomization, measurement, sample size, bias, pretests, quality control, compliance, discontinuing criteria, closing a trial, alternative designs, including observational studies, cohort studies, cross-sectional studies, case-control studies, and hybrid designs and multicenter trials. All curricula stress in-depth training in statistics and epidemiology. Among the topics often covered are discrete and continuous probability theories, linear and logistic regression techniques, analysis of variance and covariance, nonparametric testing, graphical displays, data transformation, contingency-table analysis, life-table and survival-analysis techniques, mathematical modeling, meta-analysis,

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Careers in Clinical Research: Obstacles and Opportunities cost-effectiveness and cost-utility analysis, measurement error, global and specific health and functional status instruments, and questionnaire and interview design. All programs offer training in the use of computer software and data management, as well as in the ethics of clinical research (for example, conflicts of interest, authorship, misconduct, subject selection, informed consent, institutional review boards, confidentiality, financial issues, and replication). Specific training in research management (such as resource estimation and personnel management) is included in a few of the programs. All programs include some information on how to pursue funding, and most instruct participants on how to prepare a grant proposal. Communications skills, however, are infrequently addressed. All programs combine a basic instructional curriculum with research activities under a faculty mentor. The total duration of training ranges from 18 months to three years, with most lasting two years. The first-year in most programs consists of an introductory curriculum in research methods, with the remainder of the time devoted to elective course work and a mentored research project. The least uniform aspect of the programs reviewed by the committee is the funding mechanism. Although a large number of options were mentioned, only the few programs with department of medicine or hospital support seemed to have resources dedicated to administering their respective programs. At least one program was assisted by substantial foundation support, and others were pursuing similar funding from outside organizations. Tuition costs varied substantially, from $23,000 per year for a two-year program to $5,000 for an eight-week summer course. Finally, these programs tend to be oriented more toward population-based research or clinical trials rather than toward human pathophysiology or biology. Remaining Obstacles The difficulty of obtaining stable sources of funding has been the major obstacle for newly created fellowships in clinical research and may prevent other institutions from developing similar programs. Salary support for fellows can be provided through customary subspecialty training grants, but support of faculty time is often problematic. Developing and sustaining these programs require a substantial commitment of faculty and administrative time. Established programs offer from 130 to 250 classroom hours over periods of 4 to 24 months for classes of 10 to 50 fellows each. Although some of this time is accounted for by existing courses offered through other schools or departments, much of it involves new courses and seminars designed specifically to meet the needs and abilities of clinically trained physicians.

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Careers in Clinical Research: Obstacles and Opportunities Foundation and departmental funding has been obtained to support faculty in individual programs, but this is often directed to program development, not the continuing obligations of faculty involved in teaching courses or acting as mentors to fellow-initiated projects. The ability and willingness of departments of medicine to support these activities through clinically generated revenues vary from center to center. Ensuring program support is complicated by the variety of medical specialties and subspecialties served in such programs. No umbrella organization exists at NIH to fund comprehensive training for a variety of fellows, whose stipends are supported by separate NIH institutes. Reliance on tuition support from a collection of training grants and individual sponsors with varying budget regulations makes program planning more precarious and less efficient than if centralized support was available from a single entity at NIH or some other major sponsor. Finally, tuition alone may not address the need to support faculty involvement as mentors. Faculty whose research activities are well-funded may not need additional support to supervise fellows who participate in their research activities. Because funding for patient-oriented research is modest, however, prospective mentors are likely to have limited extramural support to help fellows' projects. Furthermore, a substantial time commitment is required from faculty to be effective mentors, especially when fellow-initiated projects involve topics and methods outside their current research activities. Unless specific support for this time is available, mentorship is likely to be unsatisfactory for fellows and faculty alike. CONCLUSIONS In conclusion, the committee found that data do not exist to make an accurate assessment of the number of patient-oriented clinical investigators or the number who are being trained. Whereas career pathways for those choosing to pursue basic science investigation are clearly delineated, with established rewards and measures of productivity, comparable training pathways for patient-oriented clinical research careers are not. Given the current economic and social climate, identification of the best and most efficient ways to produce patient-oriented researchers has assumed additional importance. The escalation of health care costs, the increasing failure of the "safety net" to guarantee adequate health care for all citizens, and the emergence of AIDS and other still incurable diseases have strongly accentuated the critical need for research on the prevention, diagnosis, management, and treatment of disease. Current advances in molecular biology hold significant promise, but those advances can be fully exploited only by well-trained and committed investigators.

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Careers in Clinical Research: Obstacles and Opportunities The responsibilities and expectations of faculty who engage in basic research are straightforward, with agreed upon standards for judging success and rewarding achievement. The same is not true for individuals choosing to become clinical investigators or faculty members who participate in clinical research. Few programs rigorously train clinical scientists to provide them with a substantive foundation in clinical research methods. The responsibilities and expectations of the clinical research faculty are ambiguous and there are no agreed upon standards for measuring success. Furthermore, there appears to be few rewards even when consensus agrees that success has been achieved. Given this scenario, it is clear that medical students and other health professionals do not perceive clinical research pathways as viable options for academically based careers or careers in other employment sectors as well. The prospect of a significant infusion of funds for postdoctoral research training may be low, given such problems as the federal budget deficit and other economic woes. What is more likely is a scenario in which resources for research training remain constant or increase only minimally. Thus, future policy and program decisions will most likely involve such issues as identifying which training mechanisms work best, what is needed for their implementation in other settings, and how such programs could be fine-tuned to increase their efficiency. In addition, situations of constant or reduced funding will require policymakers to decide which mechanisms should be eliminated or scaled back to permit the expansion of other programs or experiments with promising new strategies. The committee concluded that some means must be developed for determining what programs are, in fact, training patient-oriented clinical investigators. Only then can the scientific community be confident that an appropriate number are being trained. Once those programs are identified and suitable outcomes measures are determined, the programs that are effective in training patient-oriented clinical investigators should be expanded. Some programs, such as the Clinical Associate Physician program, train this type of investigator by design. Since the General Clinical Research Center infrastructure is already in place around the country, these centers seem to be an appropriate place to begin developing programs that involve medical students and residents in human research. Finally, the desire for change will have to come from all sectors with an interest in clinical research and professional education. The federal government will have to assume the leadership role in effecting change, but it will need the full cooperation of the academic medical centers, the pharmaceutical biotechnology and medical device industries, medical and life insurance companies, professional societies, and organizations with a stake in professional education and certification for all groups of clinical investigators. All of those listed above as well as other groups need to work together progressively to improve the training of patient-oriented clinical investigators and create rewarding career paths to encourage clinicians to pursue careers in clinical research. The

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Careers in Clinical Research: Obstacles and Opportunities committee fears that failing to be proactive and addressing training pathways at this critical juncture in science and its relationship to medical care could jeopardize future progress in biomedicine.