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Special Communication |

Central Challenges Facing the National Clinical Research Enterprise

Nancy S. Sung, PhD; William F. Crowley, Jr, MD; Myron Genel, MD; Patricia Salber, MD, MBA; Lewis Sandy, MD, MBA; Louis M. Sherwood, MD; Stephen B. Johnson, PhD; Veronica Catanese, MD; Hugh Tilson, MD, DrPH; Kenneth Getz, MBA; Elaine L. Larson, RN, PhD; David Scheinberg, MD, PhD; E. Albert Reece, MD, PhD, MBA; Harold Slavkin, DDS; Adrian Dobs, MD, MHS; Jack Grebb, MD; Rick A. Martinez, MD; Allan Korn, MD; David Rimoin, MD, PhD
JAMA. 2003;289(10):1278-1287. doi:10.1001/jama.289.10.1278.
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Medical scientists and public health policy makers are increasingly concerned that the scientific discoveries of the past generation are failing to be translated efficiently into tangible human benefit. This concern has generated several initiatives, including the Clinical Research Roundtable at the Institute of Medicine, which first convened in June 2000. Representatives from a diverse group of stakeholders in the nation's clinical research enterprise have collaborated to address the issues it faces. The context of clinical research is increasingly encumbered by high costs, slow results, lack of funding, regulatory burdens, fragmented infrastructure, incompatible databases, and a shortage of qualified investigators and willing participants. These factors have contributed to 2 major obstacles, or translational blocks: impeding the translation of basic science discoveries into clinical studies and of clinical studies into medical practice and health decision making in systems of care. Considering data from across the entire health care system, it has become clear that these 2 translational blocks can be removed only by the collaborative efforts of multiple system stakeholders. The goal of this article is to articulate the 4 central challenges facing clinical research at present—public participation, information systems, workforce training, and funding; to make recommendations about how they might be addressed by particular stakeholders; and to invite a broader, participatory dialogue with a view to improving the overall performance of the US clinical research enterprise.

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Figure 1. The 2 Translational Blocks in the Clinical Research Continuum
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Figure 2. Schematic Diagram of the Clinical Research Enterprise
Graphic Jump Location
The diagram shows sponsors, research organizations, investigators, regulatory oversight entities, participants, and consumers of the research. Parts of the enterprise that are subject to regulatory oversight and to which funding flows are grouped inside the dark shaded area. Arrows within the figure indicate the general direction in which insight flows. Federal agencies include the National Institutes of Health, the US Department of Defense, the Department of Veterans Affairs, the Agency for Health Care Research and Quality, and the Centers for Disease Control and Prevention. Private funding agencies include foundations, voluntary health associations, professional societies, health insurers, and private donors. HMO indicates health maintenance organization.

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