Careers in Clinical Research Obstacles and Opportunities (1994) / Chapter Skim
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Introduction
Introduction
Pages 23-40
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From page 23... ...
Despite all the advances, however, signs of stress are surfacing throughout the health care and health research systems. The soaring costs of health care and 23
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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 emergence of human immunodeficiency virus infection has demonstrated that new diseases can arise unexpectedly, 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, diagnosis, effective therapies, and prevention strategies and to assess the subsequent outcomes of health care practices.
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Understanding of both the basic sciences and the evaluative sciences is essential to the success of clinical researchers. Moreover, novice clinical investigators require the same mentoring and nurturing in a supportive environment as those engaged in fundamental
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One dramatic example of progress in fundamental research that has opened up immeasurable clinical research opportunities is He discovery in 1989 of the gene Hat is mutated in patients with cystic fibrosis. The gene was iden~ed by using the advanced methodologies of positional gene mapping.
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Indeed, it is progress throughout this research spectrum that frames the opportunities for progress in clinical research. Increasing levels of sophistication and the assurance of an ample supply of excellent clinical investigators to carry technological advances to medical practice remain critical issues if the country is to continue to improve its health care system.
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The biomedical research community responded, and the nation's health research capacity expanded significantly. During this period research that involved interactions with human subjects, possibly with the exception of psychological studies, was primarily the domain of physician-scientists.
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Moreover, there has been no systematic way to collect and analyze data on the number of individuals who choose to perform clinical investigations, the availability of training pathways, or the outcomes of those few programs that do exist. Although many believe that quantitative factors such as debt and economic status directly influence decisions to pursue academic and research careers, there appear to be no measures for factoring in personal considerations such as the effects of mentors and role models, the desire to spend time with one's family, or having leisure time to pursue other personal interests.
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The committee was asked to consider a series of issues, including the effects of changes in the health care system on the environment for clinical research; how to improve the recruitment of medical students and residents into clinical research careers; identification of barriers to translating basic research advances into clinical practice; how to improve the relationships among clinical researchers, federal sponsors, and industry; the organization of clinical research; and how to stimulate interest in evaluative clinical sciences. Whereas that committee was asked to examine clinical research in the narrow sense of human subject research, the data from NIH that were available to the committee included all research on humans or human materials approved by institutional review boards, as indicated on Public Heals Service grant application form number 398.
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In particular, the committee was asked to investigate ways to improve the quality of training for clinical investigators and to delineate pathways for individuals pursuing careers in clinical investigation in nursing, dentistry, medicine, and other related health professions engaged in human research. The committee was charged with the following: defining clinical research, how to stimulate individuals to pursue careers in clinical investigation, how to define appropriate curricula for training, how to identify mechanisms to bridge the gap between the basic and clinical sciences, how to address funding mechanisms for clinical investigation, how to establish measures of success in clinical research other than obtaining R01 grant support, how to encourage academic and industrial institutions to protect and reward these valuable investigators, and how to ensure adequate support mechanisms for retaining clinical researchers.
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From page 32... ...
Although this classification scheme is useful for describing various research activities for budgetary purposes, it becomes less appropriate for describing cross-disciplinary clinical research, which may encompass portions of each of these categories. Classification schemes often portray a linear progression of scientific knowledge from basic biological research, to applied research and development, and to improved diagnosis, treatment, and prevention of human disease.
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Although there is a large amount of basic biological research that is not directly relevant to specific human diseases, such laboratory-based preclinical bench research may have direct links to understanding normal human function and disease. For example, control of human or retroviral gene expression as well as animal or cellular models of normal or diseased biological processes in humans is often clinically relevant, and under some classification schemes it is defined as clinical research.
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Interpreting its charge, the committee recognized that many professions are engaged in clinical research, including dentistry, nursing, pharmacy, osteopathic medicine, and the behavioral sciences, among others, and sought to include the perspectives of members of those professions as well. Nevertheless, the committee reinforced the common theme of the study and 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?
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From page 36... ...
Thus, the committee's deliberations focused on the issues surrounding the preparation and training of clinical researchers who are engaged in research that requires the direct participation of human subjects. Lastly, although the committee frequently mentions areas of potential clinical research opportunities, it was not charged with developing a research agenda in clinical research and uses the examples only for reference.
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Workshop In June 1992 the committee sponsored a one-and-one-half-day workshop entitled "Clinical Research and Research Training: Spotlight on Funding." The overall goal of He workshop was to analyze training and research funding data and to explore innovative approaches to the training and support of clinical investigators. The first day of the workshop focused on the roles and responsibilities of research sponsors including the federal government, industry,
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3. "The Effectiveness of Federally Supported Research Training in Preparing Clinical Investigators: Important Questions but Few Answers," by Georgine Pion of Vanderbilt University.
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Of this 4,284, a random sample of 4S0 from 11 institutes was used for this analysis. The committee reviewed grants provided by the National Cancer Institute, National Heart, Lung, and Blood Institute, National Institute of Deafness and Communicative Disorders, National Institute of Arthritis, Musculoskeletal and Skin Diseases, National Institute of Child and Human Development, National Institute of Neurological Diseases and Stroke, National Institute of Allergy and Infectious Diseases, National Institute of Aging, National Institute of General Medical Sciences, National Institute of Diabetes, Digestive and Kidney Diseases, and National Eye Institute.
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Chapter 2 examines the employment sectors and issues and obstacles confronting established clinical investigators, with an emphasis on academic clinical investigators. Chapter 3 discusses the available resources for funding clinical research.
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