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Special Communication |

Clinical Research in the United States at a Crossroads:  Proposal for a Novel Public-Private Partnership to Establish a National Clinical Research Enterprise

William F. Crowley, Jr, MD; Louis Sherwood, MD; Patricia Salber, MD, MBA; David Scheinberg, MD, PhD; Hal Slavkin, DDS; Hugh Tilson, MD, DrPH; E. Albert Reece, MD, PhD; Veronica Catanese, MD; Stephen B. Johnson, PhD; Adrian Dobs, MD, MHS; Myron Genel, MD; Allan Korn, MD; Nancy Reame, MSN, PhD; Robert Bonow, MD; Jack Grebb, MD; David Rimoin, MD, PhD
JAMA. 2004;291(9):1120-1126. doi:10.1001/jama.291.9.1120.
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The clinical research infrastructure of the United States is currently at a critical crossroads. To leverage the enormous biomedical research gains made in the past century efficiently, a drastic need exists to reengineer this system into a coordinated, safe, and more efficient and effective enterprise. To accomplish this task, clinical research must be transformed from its current state as a cottage industry to an enterprise-wide health care pipeline whose function is to bring the novel research from both government and private entities to the US public. We propose the establishment of a unique public-private partnership termed the National Clinical Research Enterprise (NCRE). Its agenda should consist of informed public participation, supportive information technologies, a skilled workforce, and adequate funding in clinical research. Devoting only 0.25% of the budgets from all health care stakeholders to support the NCRE would permit adequate funding to build the infrastructure required to address these problems in an enterprise fashion. All participants in the US health care delivery system must come together to focus on system-wide improvements that will benefit the public.

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Figure 1. Two Translational Roadblocks on the Way Toward Improved Public Health
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Clinical research can be viewed as encountering 2 separate roadblocks on the way toward improving public health. These 2 translational blocks have different factors creating each but whereas the National Institutes of Health has been consistently targeting the bench-to-bedside block, no one is taking responsibility for the second, which is integrally tied with the funding of the health care delivery system.
Figure 2. Organizational Chart of the National Clinical Research Enterprise
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Figure 3. Proposed Interrelationships Between the National Clinical Research Enterprise and Health Care Stakeholders
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To be effective, the National Clinical Research Enterprise must interact with and respond directly to representatives from the full spectrum of health care stakeholders.

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