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).
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.
Sung NS, Crowley, Jr WF, Genel M, et al. Central Challenges Facing the National Clinical Research Enterprise. JAMA. 2003;289(10):1278–1287. doi:10.1001/jama.289.10.1278
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