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Special Communication
March 12, 2003

Central Challenges Facing the National Clinical Research Enterprise

Author Affiliations

Author Affiliations: Burroughs Wellcome Fund, Research Triangle Park, NC (Dr Sung); Department of Medicine, Harvard University, and Clinical Research Program and Reproductive Endocrine Unit, Massachusetts General Hospital (Dr Crowley), and CenterWatch (Mr Getz), Boston, Mass; Yale University School of Medicine, New Haven, Conn (Dr Genel); California Public Employees Retirement System, Blue Shield of California, San Francisco (Dr Salber); Robert Wood Johnson Foundation, Princeton, NJ (Dr Sandy); MEDSA and Department of Medicine, University of Pennsylvania, Philadelphia (Dr Sherwood); Department of Medical Informatics (Dr Johnson) and School of Nursing (Dr Larson), Columbia University, New York University School of Medicine and American Federation for Medical Research Foundation (Dr Catanese), and Molecular Pharmacology and Chemistry Program and Leukemia Service, Sloan-Kettering Institute (Dr Scheinberg), New York, NY; School of Public Health, University of North Carolina, Chapel Hill (Dr Tilson); University of Arkansas College of Medicine, Little Rock (Dr Reece); School of Dentistry, University of Southern California (Dr Slavkin), and Department of Pediatrics and Medical Genetics–Birth Defects Center, Cedars-Sinai Medical Center (Dr Rimoin), Los Angeles; Department of Medicine and Clinical Research Unit, Johns Hopkins University School of Medicine, Baltimore, Md (Dr Dobs); Global CNS/Analgesia Clinical Research and Development, Janssen Research Foundation, Johnson and Johnson, Titusville, NJ (Dr Grebb); Medical Affairs, Corporate and Community Relations, Johnson and Johnson, New Brunswick, NJ (Dr Martinez); Blue Cross/Blue Shield Association, Chicago, Ill (Dr Korn).

JAMA. 2003;289(10):1278-1287. doi:10.1001/jama.289.10.1278

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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