social and behavioral sciences to accomplish the transformation of our health-care system from its primary focus on individual health care to a concentration on individual and population health maintenance.

Health services research, which involves the study of the efficiency, effectiveness, and costs of health care practices and systems, has become indispensable to understanding and informing the future of health care. Despite the promises of a more rational and equitable health care marketplace envisioned in the Health Care Reform Act, health care costs have been rising steadily for decades and consuming an increasing fraction of the nation’s gross domestic product. Expenditures in the United States on health care surpassed $2.3 trillion in 2008, more than three times the $714 billion spent in 1990, and over eight times the $253 billion spent in 1980. This relentless growth in costs, coupled with the aging of the American population, the severe economic recession, and the sharply rising federal deficit, is placing great strains on the private-sector, state, and federal systems used to finance health care, including private employer-sponsored health insurance coverage and public insurance programs such as Medicare and Medicaid.

The quality of the nation’s health care system has been an issue for many years. In 2001, the IOM, launched an effort to examine and recommend improvements in the nation’s quality of care. Successive IOM reports have highlighted the unacceptably poor status of our health care system as a whole, the high frequency and costs of medical errors resulting as much from systemic as individual failures, the almost unique failure of the health care industry in comparison with other sectors of the U.S. economy to adopt and exploit powerful new information technologies, and the shameful and adverse consequences of the continuing problem of the uninsured. Another effort to highlight the quality of health care began in 2003 with the publication of a series of reports by the Agency for Healthcare Research and Quality (AHRQ) that address the state of health care from the perspective of quality and disparity. These reports describe in great detail the impact of the organizational, administrative, financing, safety, access and other deficits of our cobbled-together health-care “system” on individuals, communities, businesses, and the entire nation. The need to address these major problems makes it imperative that “clinical research” be broadly conceived to encompass the assessment of health outcomes, cost-effectiveness, finance, access, information strategies, and other research related to the organization, deployment, utilization and quality of the nation’s health-care systems and services. At this time it is difficult to estimate the impact of the 2010 Patient Protection and Affordable Care Health Care Reform Act on the opportunities and challenges in clinical research.

There are many factors contributing to the continued underdevelopment of the clinical research enterprise. These include: (a) the extra time and expense required for clinical research training along with the inherent complexity, difficulty, and costs of patient-oriented clinical research, and the challenges these pose in competing successfully for sponsored research support, especially from National Institutes of Health,3 (b) the sharply declining ability to cross-subsidize clinical research from hospital and faculty clinical practice income as a result of the major changes wrought in health care financing over the past 20 years, (c) the debt burden that inclines many physicians in training to forgo clinical research careers for the more likely rewards of clinical practice, and finally, (d) the still uncertain status of the full spectrum of clinical research within the culture of the academic health center, where traditionally, basic science and clinical prowess have often been valued more highly than clinical research. Notwithstanding this formidable array of deterrents, abundant anecdotal evidence indicates that physician-scientists who leave research careers often do so because of insufficient institutional support, a perceived lack of available mentors, licensure regulations, and role models and the attendant discouragement.4

The need for increased investment in clinical research has been increasingly recognized in diverse funding programs—public, private, and philanthropic—as well as in academic medical and health centers.5 These issues were addressed by Task Force II, a group assembled by the AAMC to analyze the problems posed by the need to develop the full potential of clinical research. A number of the recommendations of Task Force II have been realized, including the requirement by the accrediting bodies of medical schools (ACME) and residency programs Accreditation Council for Graduate Medical Education (ACGME), respectively, that all medical students and all residents be exposed to the principles of clinical research; having medical schools assume central oversight of clinical research training programs in order to ensure the “protected time” of trainee; and that academic medical centers invest in shared core facilities to support translational and clinical research.

Nevertheless, that this underinvestment continues is indicated by the remarkably small fraction of the total annual expenditures directed to health care that is invested in clinical research. The NIH is the single largest public-sector source of funding for clinical research, and its commitment to clinical research has increased substantially since the late 1990s, driven in part by the recommendations of the highly influential report of the NIH Director’s Panel on Clinical Research, chaired by David G. Nathan and released in December 1997. Although NIH support of clinical research awards during

3

Kotchen, T.A., T. Lindquist, A. Miller Sostek, R. Hoffmann, K. Malik, and B. Stanfield. 2006. Outcomes of National Institutes of Health peer review of clinical grant applications. Journal of Investigative Medicine, 54:13-19.

4

 Dickler et al. 2007. “New Physician-Investigators Receiving National Institutes of Health Research Project Grants.” JAMA 297(22):2496-2501.

5

AAMC. 2006. “Promoting Translational and Clinical Science: The Critical Role of Medical Schools and Teaching Hospitals.” Washington, DC: AAMC; and Dickler, H, Korn, D, and Gabbe, SG, PLoS Med. 2006;3. e378.



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