Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 1
Careers in Clinical Research: Obstacles and Opportunities Executive Summary Health care in the United States has improved markedly over the past five decades, in large measure because of the advances made in health research by investigators who were supported by a myriad of federal agencies, industry, the private nonprofit sector, and research institutions. Diverse teams of scientists composed of basic scientists, physicians, nurses, dentists, pharmacists, and other health professionals have been involved in research ranging from fundamental biological discoveries about life processes, to behavioral and social research, to clinical and population-based studies, and to research on the delivery of health care services. Progress in many areas of fundamental biomedical research has led to a new threshold of opportunity. The techniques of genetic engineering and molecular biology have made available hundreds of new proteins with powerful effects on cell growth and behavior. Many of these will have important clinical applications for the treatment of human diseases. As another example, the ability to identify genes linked with disease through a new technology termed positional cloning, in concert with the strategic efforts to fully map the human genome, is rapidly bringing medical science to a stage where it will be possible to define the exact genetic basis for many human diseases. This explosion of new information will introduce novel diagnostic and therapeutic modalities requiring highly skilled clinical investigators trained to design and conduct human studies. For each new gene identified to be linked with a human disease, one has the potential to develop not only chemical approaches that use classical pharmacologic techniques but also new biological approaches that utilize the availability of appropriate biological products and, most recently, genetic
OCR for page 2
Careers in Clinical Research: Obstacles and Opportunities approaches that use the new science of gene therapy. The opportunities for translation of information gained from molecular biology to health care delivery have never been greater, and they can be expected to increase at a dramatic rate, creating unique societal pressures on the ability of science, medicine, and other health professional groups to respond. Tremendous advances in biology are opening doors to new therapies, creating numerous clinical research opportunities for evaluating the effectiveness of current or standard therapies. When numerous treatment regimens are possible for some conditions, the outcomes of treatment are often variable and dependent on the diverse social and behavioral attributes of patients. As more and more therapies are added to the medical armamentarium, prospective and retrospective studies of standard therapies also need to be performed. These types of questions have spawned an emerging area of clinical investigation often referred to as outcomes research. Such health services research will be needed to guide the nation's struggles to reorganize health care to expand coverage and improve quality while simultaneously holding down costs. There continues to be debate on whether the current supply of individuals appropriately trained as clinical investigators is seriously deficient. Nevertheless, the explosion of the new knowledge in molecular biology, medicine, and health care, as well as in medical informatics will create the need for substantially more expertise—particularly for more fully trained physicians and other health professionals in academia, government service, and industry—to transform these discoveries into cost-effective diagnoses and treatments for human disease. Since most of these clinical investigators are trained in academia, it is important to recognize the crucial roles that academic health centers (AHCs) have in the career paths of clinical investigators and that there are many external factors that have an impact on the AHC environment. The escalating costs of health care and the large number of uninsured and underinsured people in the United States have thrown health issues into the policy arena at all levels of government. In medicine, highly subspecialized medical training, a declining interest by U.S. medical students in primary care training, and shortages of physicians willing to practice in rural or inner-city areas are all cited as symptoms of a worsening problem. The spontaneous rise of human immunodeficiency virus infection and the rapid transmission of HIV infection to all segments of society has demonstrated that new diseases can arise at any time, and that a multifaceted approach spanning a variety of fields of research and a range of professional research scientists is needed to develop fundamental knowledge about a disease process, develop and test new diagnostic and therapeutic approaches, design prevention strategies, and assess the subsequent outcomes of health care practices. This can only be accomplished with a sufficient supply of highly talented and well-trained researchers in all areas of research.
OCR for page 3
Careers in Clinical Research: Obstacles and Opportunities FOCUS OF THIS REPORT The Institute of Medicine Committee on Addressing Career Paths for Clinical Research sought to derive a definition of clinical research in terms of research activities or goals that would cut across artificial boundaries. Although it is difficult to arrive at an unambiguous definition agreeable to all parties, the committee believes that clinical research should be broadly defined as the elucidation of human biology and disease, and its control. Thus, there is a continuum of research spanning a wide range of activities that can be regarded as clinical research. Using this definition (Chapter 1, page 35) as a departure point, the special theme and focus of this study was patient-oriented clinical research, defined as that research which requires ''hands-on" participation with a human subject. This subset of clinical research was defined as human research and was considered a subset of the entire spectrum of clinical research. Furthermore, the committee emphasizes that investigators in many professions are engaging in human research, including dentistry, nursing, pharmacy, and the behavioral sciences, among others. Each of these groups has developed its own clinical research capabilities to different degrees, depending on the research focus and resource base. For example, the diversity of the spectrum of research, from basic to clinical, in dentistry probably parallels that in medicine. However, dental training paths and the reduced level of third-party reimbursement for dentistry differ significantly from those in medicine, and have certain implications for training clinical investigators and performing clinical studies. Nursing, however, has historically been a discipline whose research has focused on patients rather than bench-type research. The formation of the National Center for Nursing Research at The National Institutes of Health (NIH) and its recent elevation to institute status have provided a solid foundation for peer-reviewed, patient-oriented clinical research in this discipline. The similarities and differences among the various disciplines added another dimension to this study, particularly with regard to making crosscutting recommendations. Nonetheless the committee felt that it was vitally important to include the perspectives of all groups engaged in human research. The committee posed the following global questions about clinical research and the clinical research workforce: What can clinical research accomplish now and in the future to improve medical care? Is the current clinical research community poised and prepared to accomplish these goals?
OCR for page 4
Careers in Clinical Research: Obstacles and Opportunities If the clinical research community is not prepared to accomplish these goals, what is the evidence that there is either inadequate clinical investigation or an inadequate number of well-trained clinical investigators to meet this need? What are the best approaches or best vehicles for change to improve clinical investigation and ensure a supply of highly competent clinical investigators to meet these needs and accomplish the research goals? FINDINGS Accurate data on the number of active clinical investigators or clinical research trainees are unobtainable from any current database. The complexities and heterogeneities of the medical and other health professional research workforces have confounded previous analyses, and this committee, too, was unable to apply existing models to estimate future workforce needs. Nonetheless, recognizing that vast opportunities are arising and the current state of the enterprise, the committee believes that the human resource pool will be seriously deficient for conducting investigations with human subjects in the near future—if it is not already. The committee drew several conclusions from their analyses: The current level of training and support for health professionals in clinical research is fragmented, frequently undervalued, and potentially underfunded. This is especially true for those concerned with human research, that is, research focused on the human subject. A number of variables make the pursuit of clinical investigation relatively unattractive for medical students and students of the other health professions. These include the prolonged period of clinical training required of current medical graduates; the effect of the accumulated debt burden on career choice; the relative lack of role models and mentors; the perceived instability of research funding from NIH and other federal agencies; the real funding instability as it pertains to the individual investigator; the perceived lack of support for research, particularly as it relates to human research; the lack of emphasis on clinical research training in the curriculum; and the multiple demands upon the trainees not only during their period of training, but also as they begin their careers on the faculty, in industry, or in government service. The voluntary and certifying accrediting bodies have a significant influence over individual career decisions, and in an effort to improve quality in one area, they may create significant hurdles in other areas. For example, meeting the new requirements for specialty or subspecialty board recertification which requires a broad overview of the entire discipline may conflict with the necessity of maintaining a narrow focus in a particular area of clinical research.
OCR for page 5
Careers in Clinical Research: Obstacles and Opportunities Relatively few programs adequately prepare physicians and other health professionals to undertake research involving human subjects, and their successes are unproven. Managed competition represents the new paradigm for the funding of health care. The development of this model is likely to lead to the formation of large organizations of provider groups or health plans, which in turn will contract with consortia of employer groups or alliances to provide health coverage for employees and their families. This change will have a major impact on the ability of academic health centers to support their academic missions and thus will have a direct effect on the support of research and education. Unless new approaches to the support of clinical investigators and academic health centers involving the participation of third-party payers are forthcoming, it is likely that this paradigm shift in health care financing will seriously compromise the translation of results from fundamental research into improved health care. Funding for investigator-initiated human research is difficult to obtain. Whereas industry is obligated to conduct clinical trials during product development to meet regulatory conditions for market approval, there is no profit motive to support investigator-initiated studies on medical practice. The committee performed an analysis on a subset of R01 grants that were active in 1991. The purpose of that analysis was to determine the number of awards and amount of funding that were actually committed to patient-oriented research. Of the approximately 30 percent of all R01 grants indicating the use of humans or human materials, the committee determined that only one third (or about 10–12 percent of total R01s) of this grant pool actually involved human subjects. Although there are other mechanisms for funding human research, the R01 pool is the largest source of funds for investigator-initiated studies, both basic and clinical. Clinical investigators devote months or years to developing the appropriate design for a clinical study. Barriers include the need to submit numerous protocols for approval within their institutions, the need to have adequate infrastructure and personnel for conducting a clinical study, the competing demands on their time to provide patient care as well as teaching and research, and the amount of funding available for investigator-initiated human research. The measures of scholarly productivity for clinical investigators are not well-defined, and to many university promotion committees, the research activities of clinical investigators may be considered nontraditional. Responsibility for oversight of the nation's clinical research capacity is fragmented at every level, whether academic or governmental. Thus, there appears to be little prospective planning involving all interested parties to identify clinical research needs or new opportunities. As a consequence, no organized segment of society, public or private, focuses attention on the clinical investigator to ensure and encourage a career path(s) at so critical a phase in the history of human health.
OCR for page 6
Careers in Clinical Research: Obstacles and Opportunities The committee concluded that new opportunities for clinical research are growing at a rapid pace. In addition, the committee believes that the present cohort of clinical investigators is not adequate and many are not suitably prepared to address many of the important questions that are arising, particularly in areas like gene therapy and outcomes research. Furthermore, numerous obstacles confront clinical researchers and clinical research trainees at various points in their career pathways, and these obstacles may dissuade them from pursuing clinical research careers. The committee is concerned that the health research community may be unable to address even a fraction of these opportunities, and this may delay substantially the development of new advances in medicine. To foster improved clinical investigation, to facilitate and stimulate high-quality training for clinical investigators, and to ensure a supply of highly skilled clinical investigators, the committee calls for a multifaceted and concerted effort. The U.S. congress, industry, professional organizations, organized medicine, NIH and other federal agencies, as well as the nation's universities and academic health centers will need to work in partnership to meet these research and training needs. Voluntary health organizations, accrediting and certifying agencies, and medical professional societies all have a role to play in the careers of clinical investigators. Most of the committee's recommendations do not necessarily require increased funding to effect change. The committee emphasizes that effective and strong leadership in academic health centers, in government, and in industry is a critical ingredient in the process for improving clinical research and developing rewarding clinical research career pathways. Whereas each individual recommendation is directed to a specific group or organization, collectively the recommendations represent a package of reforms needed for redefining careers in clinical investigation. RECOMMENDATIONS NIH and Other Federal Agencies Supporting Research Among the federal agencies, NIH continues to be the trendsetter in the support of biomedical research, both basic and clinical, and in the training of clinical investigators. Accordingly, efforts carried out by NIH will have a major impact on progress in the development of the clinical investigator. A number of approaches are recommended to enhance the effectiveness of NIH as a leader in patient-oriented clinical research.
OCR for page 7
Careers in Clinical Research: Obstacles and Opportunities Data Analysis NIH and the other federal agencies that sponsor human research must develop and implement a process to prospectively collect data that accurately identify the subsets of human research. The present system of classifying clinical versus nonclinical research is woefully inadequate and that for identifying human research is nonexistent. A large amount of research is recorded as clinical only because it is necessary to identify those grants that use human materials as well as human subjects. The absence of such categorization makes it impossible to accurately determine the level of investigator-initiated support for human research. Even the retrospective analysis performed by the committee (see Chapter 3) was not adequate for understanding either the levels or trends in support for human research. NIH and other federal science agencies should prospectively collect data that document the extent to which patient-oriented clinical investigations are being supported and the success rates of such grant applications in the peer review process. At a minimum, this should include the collection of information and separate documentation as to the use of human materials, the study of human subjects, and the conduct of human epidemiology. Study Section Oversight The committee recommends that the NIH director appoint a standing committee to regularly review the compositions, functions, and outcomes of study section activities, particularly as they relate to human research. Rigorous application of scientific methods spanning the spectrum from fundamental to clinical research and within clinical research to human and population-based research requires specialized knowledge and skills. Therefore, it is important to ensure that the study sections at NIH are composed of individuals with the appropriate breath and depth of knowledge to evaluate the research proposals assigned to that study section. An oversight committee that would largely comprise extramural investigators with expertise ranging across the entire spectrum of research should be established. A similar recommendation to form a Peer Evaluation of Extramural Research (PEER) was put forward by a 1992 internal review panel convened to examine the peer review system at NIH.
OCR for page 8
Careers in Clinical Research: Obstacles and Opportunities Newly Independent Investigators The committee recommends that new mechanisms for supporting newly independent clinical investigators be developed. Funding must be available to support newly independent clinical investigators who are just initiating their investigative careers. This segment of one's career development often becomes the most critical and the time when so many of the disincentives converge to dissuade newly trained clinical investigators from continuing to pursue clinical research career paths. Many believe that First Investigator Research Support and Transition (FIRST) awards have been highly successful in nurturing the careers of newly independent investigators. Indeed, FIRST awards could also be an avenue for launching a career in clinical investigation, but the structure of the awards and the ceiling on costs are more suited for bench-type research rather than human subject research. Stabilization of funding could well represent the single most important factor to the individual clinical investigator. This support has come from many sources in the past, perhaps most importantly from the academic health center. As noted later, this type of support is in jeopardy because of the changing health care system. Centers and Program Projects The committee strongly supports the efforts by NIH to develop centers and program projects to support research and infrastructure in exciting new areas of multidisciplinary, crosscutting research. Not only is the development of these programs critical to the support of clinical research but they also provide one of the few mechanisms available for the development and support of core facilities. Such core facilities are essential to individual clinical investigators attempting to overcome obstacles in the progress of their own research. Centers not only provide physical infrastructure but also serve as a locus of intellectual capital and collaboration necessary for conducting human research. The availability of small feasibility grants as part of larger center grants often stimulates investigators to extend their expertise to new areas beyond their current levels of interest.
OCR for page 9
Careers in Clinical Research: Obstacles and Opportunities General Clinical Research Centers The committee recommends that Congress be made aware of the clinical research and training potential of the General Clinical Research Centers (GCRCs) and recommit its support for this vital resource. GCRCs serve as an important infrastructural resource for those institutions fortunate enough to have one. In the federation of disease and organ institutes of NIH, it is frequently difficult to muster support from Congress or special interest groups for centers like the GCRCs that do not focus on any one disease or organ. Strong GCRCs are, and will continue to be, critical in meeting the future promise of the advances in biomedical research as they will be applied to improving the quality and cost-effectiveness of patient care. In the past, GCRCs have played a pivotal role as a resource for investigators attempting to elucidate physiological parameters of healthy and disease states in human subjects. In the future, GCRCs must also serve as a vital link in elucidating the applications of biological products and gene therapy in human populations. GCRCs also provide attractive sites for studies related to the clinical development of novel drugs and could serve as important resources or loci for establishing programs for outcomes assessment. There are presently 75 GCRCs in the United States. The budget for GCRCs has not grown in real terms for a number of years, and actually has declined when corrected for inflation. The GCRCs require strong federal, corporate, and institutional support. Multiyear Stabilization The committee recommends that Congress make multiyear appropriations to NIH and other federal agencies that sponsor research. Similar recommendations have been made by other groups examining research funding and the appropriations process. Research in all areas, and particularly human research, requires a long-term commitment to develop appropriate hypotheses, gain the requisite protocol approvals, and recruit a patient population for study. The perceived instability of federal funding for research, as well as the actual instability for the individual clinical investigator, appears to be an important obstruction in the choice of clinical research as a career for the young health professional. A multiyear commitment from the executive and legislative branches of the federal government for the support of NIH and other research agency appropriations would represent a major benefit to this perceived instability—which often
OCR for page 10
Careers in Clinical Research: Obstacles and Opportunities translates into real instability related to grant cycling—of grant funding for the scientific community. In addition to multiyear stabilization of research funding, the formalization of administrative mechanisms to provide interim support from NIH during gaps in funding would provide further stability. Support of Training Programs The committee recommends that NIH and other federal agencies develop tracking mechanisms to be able to determine the outcomes of their training programs as they relate to clinical research. Model programs should be studied, and those that have proven track records in preparing successful clinical investigators should be expanded and replicated. Those with poor track records should be closed or replaced with successful models. The conduct of patient-oriented clinical research requires a broad knowledge base and multiple skills. For some areas of investigation, a working knowledge of fundamental science is essential; for others, uncommonly strong clinical skills are necessary. And for some studies, a sophisticated analytic capability is needed to make valid inferences from experimental and nonexperimental data. The committee believes, however, that there is a core of knowledge and skills common to clinical investigation that serves not only as the foundation for scientific discovery but also as the basis for clinical appraisal of evidence in decision making in health care for all health care professionals. Furthermore, if the problem with obtaining funding for human studies through peer review is the poor quality of grant proposals, action must be taken to improve the ability of newly independent investigators to draft sound proposals for clinical studies. The current training grants (T series awards), fellowships (F series), research career development awards (RCDAs), physician or dentist scientist awards (K series), and other training avenues provided through NIH should be reviewed with regard to their efficacies and successes in training creative and productive investigators. One earlier analysis by NIH in 1989 demonstrated that clinical trainees who serve for less than 9 months on training grants (T32) in clinical departments do not receive adequate training to become competitive in the NIH grant system. An effort should be made to identify and expand programs that are the most successful in supporting human research. The method of review should include prospective mechanisms for tracking the professional outcomes of trainees, the total financial support required to relieve the individual candidates of the need to obtain funding through other sources, and a component of the training that fosters the transition from trainee to principal investigator status.
OCR for page 11
Careers in Clinical Research: Obstacles and Opportunities Such programs should continue to include at least three years of research training in addition to standard residency training. Again, experience in applying research skills under the supervision of experienced investigators is essential. Combination of residency and such fellowship programs, with integration of clinical and research training over a 6- to 10-year period, should be encouraged for trainees who make early commitments to careers in clinical research. Such combined programs could be particularly advantageous for patient-based research, which necessarily requires long periods of patient observation and data collection. The committee recommends that selected centers be encouraged to develop programs of interdisciplinary studies that lead to advanced degrees in evaluative sciences related to clinical research. Here the goals would be to enhance the theoretical basis for clinical research as well as the development of more efficient and effective research methods. Funding for these model programs must not compromise current research funding, and therefore should be derived from incremental new financial resources, possibly through congressional appropriations or funds derived from private sources (pharmaceutical industry, insurance companies, or nonprofit organizations). The committee recommends that NIH expand the medical scientist training program and the dentist scientist training program specifically for training investigators in the skills of performing patient-oriented clinical research. Data should be collected and analyzed to identify those programs that have proven track records in preparing successful clinical investigators. Successful programs should be expanded and replicated and those with poor track records should be closed or replaced with successful models. Successful medical scientist training programs and the dentist scientist training programs leading to the combined M.D. or dental degree and Ph.D. degree appear to represent the most useful approaches to the production of highly qualified physician and dentist-scientists and should be expanded. The number of applications for these programs far exceeds the capacity; an expanded number of funded positions would be filled by highly qualified applicants seeking careers in clinical research. Some of the positions should be designed to focus on training in human research. The committee also encourages the expansion of NIH-funded combined programs that lead to the M.D. degree (or other professional degrees) with other advanced degrees in disciplines such as economics, epidemiology, public health, biostatistics, and ethics.
OCR for page 12
Careers in Clinical Research: Obstacles and Opportunities The committee recommends that each General Clinical Research Center (GCRC) evaluate the outcomes of the Clinical Associate Physician (CAP) program and consider expanding it if it is found to be effective for training patient-oriented clinical researchers. GCRCs should also develop a program to involve medical students and residents in clinical research activities in the centers. This recommendation, in concert with an earlier recommendation, would represent a recommitment to the GCRC program to make these centers the loci of pioneering clinical studies in numerous disciplines. The CAP program of GCRC, is an important source of support for the training of clinical investigators committed to the field of human research. GCRCs and the CAP program deserve a careful analysis, and expansion if deemed appropriate. Other federal agencies should reexamine their roles in supporting clinical research. Indeed, the successes of these agencies in support of both basic and clinical research for the future will be extremely important to facilitating the flow of information between the laboratory bench and the patient's bedside, and each agency can play a very specific and relevant role. Included in this group of agencies are the Departments of Veterans Affairs, Defense, Energy, Agriculture, and Education, the Centers for Disease Control and Prevention and the Agency for Health Care Policy and Research within the Department of Health and Human Services, and the National Science Foundation. The committee encourages the U.S. Congress to expand the support of research and training by each of these federal agencies as they define their priorities at this critical time in the history of health care. The committee recommends that NIH, the other federal agencies that sponsor clinical research, industry, and the private, nonprofit agencies develop or expand debt relief packages for individuals desiring to pursue clinical research career paths. The accumulating debt burden that students engender in pursuing professional training, particularly in medicine, creates a serious concern for many as they consider career options during their period of training. The committee believes that the pursuit of careers in clinical investigation may be seriously affected today by the prolonged period of training required, the instability of clinical research as a career option, and the modest levels of compensation that can be expected compared with those for other available career pathways for similarly trained individuals. Existing programs that pay medical school tuition, such as the longstanding Medical Scientist Training (MST) program, or that pay back educational debt, such as NIH's AIDS Research Debt Relief Program, to
OCR for page 13
Careers in Clinical Research: Obstacles and Opportunities promote research careers have demonstrated positive results, and the committee encourages their expansion if they are proven to be effective. Medical schools have demonstrated their support for such programs, as evidenced by investing their own resources to fund nearly 50 percent of the M.D.-Ph.D. slots in the country. The committee believes strongly that mechanisms should be found to develop a funding base to underwrite a debt relief program for individuals who are committed to a career in clinical investigation. Although resources for supporting such program areas most likely must come from some new funds, the committee feels that a growing investment should begin now to ensure the availability of talent in the next several years. The committee believes that NIH is best equipped to implement these programs for the federal government and recommends that NIH be empowered to develop the appropriate organization and infrastructure. The committee urges the sponsors of clinical research and clinical research training to act independently to initiate programs of debt relief for these individuals. UNIVERSITIES AND ACADEMIC MEDICAL CENTERS The key to the success of individual clinical investigators is the university academic health center where most are likely to have acquired their research skills and where many conduct clinical investigation studies during a significant portion of their careers. The academic medical center is defined as the medical school and its related university hospital(s). The attractiveness of careers in clinical research can be enhanced substantially by the leadership at many levels within these institutions. The institutions and their leadership are now under considerable stress as a result of health care reform. Nevertheless, the support of teaching and research must continue to be among the highest priorities. Academic Recognition and Rewards The committee recommends that academic institutions where clinical research is conducted review their promotion guidelines to prevent bias against clinical investigators and establish reward mechanisms to acknowledge the scholarly contributions of clinical investigators. The scholarship of the successful clinical investigator should be appropriately recognized in the academic setting. This would include recognition that the nature of their research, the sources of their funding, and the journals in which they publish may differ substantially from those of the investigators in fundamental research. Some institutions have chosen multiple pathways for
OCR for page 14
Careers in Clinical Research: Obstacles and Opportunities clinicians, whereas others have adhered to single promotion pathways for all investigators. Whatever the pathway, it is incumbent on institutions to create a fair and equitable means for recognizing and rewarding the scholarly contributions of clinical investigators. Faculty Protection The committee recommends that academic institutions establish reward mechanisms to acknowledge the importance of teaching, advising, and mentoring by clinical investigators. The existence of faculty in clinical investigation who teach, advise and mentor trainees, and serve as role models is important in attracting students to careers in clinical investigation. These faculty activities, therefore, must be recognized and rewarded. Such recognition in the academic health center includes promotion, protected time, and financial support. Leaders at all levels within these institutions must define their expectations of junior faculty and support them so that these young men and women can meet or exceed those expectations. In many institutions support has been successfully facilitated by the formation of specific clinical faculty tracks; others have developed equally successful single-track systems that are capable of recognizing the diversity of academic productivity. The committee does not endorse one system over another; rather, it encourages institutions to establish suitable means for recognizing the contributions of clinical investigators and developing appropriate reward systems. Infrastructure The committee recommends that research institutions provide clinical investigators with the appropriate infrastructure in order to conduct high-quality clinical studies. In addition to well-trained and adequately funded patient-based clinical investigators, the successful execution of clinical and especially human research requires a suitable institutional infrastructure. University-based and research-intensive medical centers should develop mechanisms to achieve the optimal infrastructure to support inpatient-and outpatient-based human research. The features of such an infrastructure may include a clinical practice that is structured to deliver health care in a scholarly and investigative fashion and the integration of students, residents, fellows, and other health care professionals into human research activities. In addition, multidisciplinary facilities are required at academic institutions to support core requirements for clinical research; these
OCR for page 15
Careers in Clinical Research: Obstacles and Opportunities might include such elements as biostatistics, data management, and an opportunity to work with other health professionals. Creative start-up efforts through academic institutional mechanisms to establish core facilities that will seek continued funding through extramural sources represent an important activity that should be strongly encouraged within the academic setting. Medical School Curriculum The committee recommends that the curriculum of the medical school and those of other health professional schools should cut across departmental lines and be led by a team of educators committed to discovery in the basic laboratory, the clinic, and the community. Exposure to the principals of clinical research should occur in the first-year of the medical school curriculum. This would include, but not be limited to, practical application of disciplines such as epidemiology, statistics, and the design and ethics of clinical trials in a setting such as a general clinical research center. Thus, the committee strongly encourages increased opportunities for early participation of students in high-quality research, including human research, and exposure to role models. The committee recognizes the health care needs of society and the pressure to increase the proportion of practicing generalists. These individuals will best meet the needs of society if they are educated by a process that emphasizes discovery. Indeed, many of these individuals can and should contribute to clinical investigations as their careers in primary care develop. Furthermore, the committee believes that each health professional school should have a program in place that requires in-depth, meaningful participation in research, including patient-based clinical research. Such programs might include a required thesis for research performed over an extended period of time (for example, one-year involved in research) or an article submitted for publication in a peer-reviewed journal. Although this approach may not be possible in all settings, the committee recommends, as a minimum, a program that seeks out medical students and other health professionals with an ability and interest in research and that provides a concrete opportunity, it is hoped with funding, for a program of research training. The committee encourages other health professions to examine their training programs and curricula to ensure that they attract and support individuals capable of performing human research-related to their professions. Such funding could be provided by academic institutions, foundations, industry, government, or an alliance thereof.
OCR for page 16
Careers in Clinical Research: Obstacles and Opportunities Postgraduate Training The committee recommends that postgraduate training programs implement programmatic changes to ensure that residency and fellowship training programs include ongoing exposure to basic elements of experimental design, biostatistics, epidemiology, and decision theory in relation to measures of therapeutic effectiveness, diagnostic accuracy, prognosis, and screening and disease prevention. The importance of expanding current model postgraduate training programs, which have proven to be successful in the training of clinical investigators, has been noted earlier and deserves reemphasis here. Ideally, these programs will be integrated with clinical teaching as well as relevant areas of investigation that emphasize the translation of research to clinical decision making and the role of the clinical appraisal of evidence in that process. Teaching and research institutions cannot rely on other sectors to effect change in clinical research and clinical research training and must begin to make the necessary changes in their own programs. The committee feels that these changes will not only produce clinical researchers with better skills but physicians who can provide better care as well. ACCREDITATION AND CERTIFICATION ORGANIZATIONS The voluntary accrediting agencies responsible for overseeing the education and training programs for health professionals in the United States are highly developed and successful. This includes the Liaison Committee for Medical Education, the Accreditation Committee for Graduate Medical Education, the Accreditation Committee for Continuing Medical Education, the Joint Commission for Accreditation of Health Care Organizations, and the accreditation bodies for other health professions. In addition, there is a voluntary certification process to recognize individual qualifications in pursuit of specialty careers in organized medicine and dentistry. Some of these certifying bodies, such as the American Boards, are organized under the umbrella organization the American Board of Medical Specialties. Each of these organizations plays a major role in establishing standards and ensuring continuous quality improvement in the education and training process, both for the program and for the individual. Hence, evolving changes in the nature of the education and training programs that affect clinical research will, of necessity, require cooperation and participation of the accrediting and certifying bodies. Their strong support and cooperation would be extremely helpful in facilitating the entire process.
OCR for page 17
Careers in Clinical Research: Obstacles and Opportunities Liaison Committee on Medical Education The committee recommends that the Liaison Committee on Medical Education (LCME) recognize the importance of scientific inquiry by effecting changes in the medical school curriculum that encourage an appreciation of clinical investigation and participation in clinical research. LCME is the national authority for the accreditation of medical education programs leading to the M.D. degree. The committee believes that LCME must play a key role in effecting changes in medical school curricula that will encourage lifelong learning and intellectual curiosity. Such curriculum changes in medical schools, as well as changes in other health professional schools, must recognize the crucial role of scientific inquiry and incorporate necessary changes that are supportive of individuals pursuing research career pathways, particularly clinical research pathways. Accreditation Committee for Graduate Medical Education The committee recommends that the Accreditation Committee for Graduate Medical Education (ACGME), through its Residency Review Committees (RRCs), ensure that the environment of graduate medical education and training programs is conducive to and supportive of an atmosphere of intellectual growth and scientific inquiry, particularly as it relates to clinical investigation. ACGME is made up of the 24 RRCs, which accredit the individual residency training programs. The committee fully recognizes the need for a long period of training and for the rigid clinical requirements that exist. Nevertheless, the explosion of knowledge in basic and clinical research requires that the health professionals of the future develop the ability to critique study designs and published results. In addition, physicians, dentists, and other health professionals trained and expert in clinical research are needed to transfer the advances of basic science to the clinic and to ensure that epidemiologic and outcomes studies are conducted appropriately. Such an atmosphere could be achieved by the organization of specific clinical investigator pathways and the development of a curriculum that provides exposure to elements important in translating basic advances to the resolution of clinical problems. For those programs designed to train clinical investigators, a mechanism to measure the quality and success of research training must be developed.
OCR for page 18
Careers in Clinical Research: Obstacles and Opportunities American Board of Medical Specialties The committee recommends that the member boards of the American Board of Medical Specialties (ABMS) establish appropriate criteria to recognize and encourage the development of clinical investigators in their respective specialties, including a careful analysis of the recertification process on clinical investigator careers. The certifying boards of ABMS, which establish the basic requirements for individuals to receive certification in specialty disciplines, should be strongly encouraged to develop specific clinical investigator pathways to allow individuals who pursue their disciplines to substitute experience and training in clinical investigation for other requirements. Familiarity with clinical research methodologies and interpretation should be tested during the certification process. Most boards that provide certification in organized medicine within the United States have developed time-limited certifications. Individuals in their disciplines must participate in a recertification process within a specific time frame (generally every 10 years) to continue to be recognized as a specialist in the field. The committee is concerned that this process, although appropriate from the perspective of ensuring the clinical excellence of the certified physician, could provide a major disincentive for the pursuit of a career in clinical research. This issue deserves special review and analysis by the certifying boards in medicine and other bodies governing specialists in other health professions. EXECUTIVE BRANCH, CONGRESS, INDUSTRY, FOUNDATIONS, AND PROFESSIONAL SOCIETIES Health care reform is a national goal that is focused on bringing cost-effective quality care to all Americans. The issues involved currently occupy much of the national agenda. Clinical research must be a critical element in health care reform because it produces efficient and effective therapies and strategies for patient care in the future. The prevention and cure of disease are the ultimate benefits of clinical research. Indeed, the return on investment will be enhanced substantially by the removal of the obstacles and constraints in the smooth translation of advances in science to health care. Federal science agencies, the pharmaceutical and biotechnology industry, private nonprofit organizations, research institutions, the insurance industry, society at large, and medical professional societies all have a vested interest in clinical research. However, the committee is concerned that the fragmented interest in clinical investigation among many institutions and organizations and the lack of cooperation or coordination among the various groups is an
OCR for page 19
Careers in Clinical Research: Obstacles and Opportunities impediment to a systematic approach to the training of highly skilled clinical investigators. The committee believes that some means to bring together all the interested parties with the appropriate resources and authority to effect change could provide the critical catalytic process necessary to redefine clinical investigator career pathways in this new era of health care. Although this report analyzes the current status of clinical research, the changing dynamics of clinical research within the rapidly changing realm of biomedical research and health care reform require that consistent attention be paid to this vital segment of the research enterprise. Thus, the committee felt that such a forum needs to be an ongoing effort to provide data analysis and continuing attention to the problems of the clinical investigator. The committee considered several proposals for action including the following: Create a panel with broad representation by all interested parties that is funded through membership fees and that has the authority to distribute funds for training and research. Such an organization might be a private- or public-sector organization with combined funding from the federal government and the private sector. For clinical research, which the committee views as critical to national security and economic competitiveness, such an organization could include funding and representation from the federal science agencies, the pharmaceutical and biotechnology industry, third-party payers, the health and life insurance industries, and other interested groups. Another option could be the establishment of a permanent federal commission or council to monitor the nation's clinical research activities and advise the Congress and other sponsors on the needs of clinical investigation and the clinical investigator. Such a commission or council may or may not have authority over funds. For example, the President's Commission on AIDS is a senior-level advisory body to the administration and federal science agencies. The private sector could act alone by forming a coalition of special interest groups (industry, third-party payers, academia, and nonprofit organizations) that could act on behalf of the groups' collective interests to identify critical areas for investment in clinical research. For example, the Alliance for Aging Research promotes research in this particular field as well as collects funds from many sectors to establish national centers of excellence in aging research. The committee does not endorse any one proposal, but presents them for consideration and to raise the consciousness of all concerned about the difficulties
OCR for page 20
Careers in Clinical Research: Obstacles and Opportunities related to clinical research and clinical research training in hopes of ensuring that they are not overlooked as the nation grapples with health care reform. Conflicts of Interest The committee recommends that the government, universities, research institutes, and industry develop appropriate guidelines and means to resolve conflicts of interest to encourage strong cooperation in clinical studies. The committee believes strongly that the translation and application of advances in research to patient care require a strong partnership between research universities and medical centers and industry. Effective interdependent relationships between clinical investigators, their institutions, and industry are necessary for the United States to continue to lead the world in developing innovative therapies. Facilitating technology transfer by both parties with the support of the federal government is vitally important and deserves special attention. This will require new standards in the definition and resolution of conflicts of interest at all levels. Healthy relationships that encourage full cooperation can build on this interdependence and can be synergistic. Preserving Academic Health Centers The committee emphasizes that the federal government and third-party payers recognize the vital contributions that academic health centers (AHCs) make in medical education and clinical research to improve health care and recommends that they take appropriate action to reimburse AHCs according to their broad mission. The committee acknowledges that the costs of health care in the nation's AHCs appear to exceed those of health care providers without a broader mission for teaching and research. Because of AHCs' commitment to research and teaching, these institutions frequently cannot compete on a pure cost basis with other providers, and payers must be made aware of their broad mission. The committee believes that there is a need to identify, isolate, and detach those costs unique to the AHCs that provide benefit to all stakeholders and to provide payment through a separate income stream funded by all payers. This in effect would provide parity so that AHCs could compete fairly in the provision of patient care on the basis of quality and price. Providing state-of-the-art care and
OCR for page 21
Careers in Clinical Research: Obstacles and Opportunities continued innovation requires a sound underpinning of basic and clinical research. It is important that the level of payments for graduate medical education recognize all the costs involved in graduate training, including residents' stipends and benefits, salaries and benefits related to faculty teaching, and overhead costs related to the graduate education process to preserve the most creative and innovative health care and health research systems in the world. Graduate medical education is not the only factor that accounts for the higher costs at AHCs. Health care professionals at AHCs often treat patients who are more seriously ill, provide infrastructure for biomedical and health services research, and offer clinical training experiences for undergraduate medical and other health professional students—costs that add to an institution's cost base. In recognition of these additional costs, the Medicare program has historically paid teaching hospitals an indirect medical education adjustment. Likewise, some modified version of an adjustment to account for those costs unique to AHCs, above and beyond the direct costs of graduate medical education, will be necessary in a managed competition environment. The adjustment should be formula driven rather than based on year-to-year appropriations and, again, should be funded by all payers. Finally, all accountable health plans, when feasible, should include an academic health center as a centerpiece of their networks. Such a requirement would guarantee all citizens access to the latest in state-of-the-art care when medically necessary. At the same time, it would help to ensure an adequate flow to academic health centers of the patients on whom their educational and human research programs are completely dependent. Without access to suitable patient populations for clinical studies, the United States will lose its leadership in opening the frontiers of innovative and effective health care. This approach might be further complemented if regional ''centers of excellence" were established in AHCs for the evaluation of emerging technologies and specialized methods of treatment. AHCs would be the natural place for locating such centers, given their strong emphasis on research, particularly if they have a health services research component. The regionalization of certain emerging technologies would also help to control the widespread diffusion of new technologies absent sufficient outcomes research that could be used to judge their cost-effectiveness.
OCR for page 22
Careers in Clinical Research: Obstacles and Opportunities This page in the original is blank.
Representative terms from entire chapter: