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Robert M. Califf, MD

JAMA. 2009;302(18):2025-2027.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

As the culture of medicine moves toward an evidence-based learning health system, high-quality research is needed to guide choices made by patients, physicians, administrators, and policy makers. However, the system responsible for generating that evidence in the United States is in crisis, as demonstrated by erosions of system efficiency,¹ waning interest in clinical research among practitioners, and financial insolvency among participants in the clinical research enterprise.

Recent efforts have aimed at improving research coordination and data analysis through centralized organization and application of technology, while leveraging databases and registries has achieved an exalted status in comparative effectiveness research. Less attention, however, has been paid to issues surrounding prospective research in the patient care setting, and the fundamental unit of clinical research—the clinical research site (CRS)—has been particularly neglected. Despite their vital contributions, CRSs are largely underappreciated in the clinical research enterprise, toiling in obscurity while others . . . [Full Text of this Article]

Key Issues Facing CRSs

Conflict of Commitment

Financial Pressures

Regulatory Burdens, Risk Aversion, and Research Priorities

Author Affiliations: Duke Translational Medicine Institute and the Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, North Carolina.

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