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Special Communication
March 3, 2004

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

Author Affiliations

Author Affiliations: Harvard Medical School, Director of Clinical Research, Massachusetts General Hospital, Reproductive Endocrine Unit, Boston (Dr Crowley); Medical and Scientif Associates, Limited Liability Corp, Lower Gwynedd, Pa (Dr Sherwood); Blue Shield of California, San Francisco (Dr Salber), University of Southern California School of Dentistry, Los Angeles (Dr Slavkin), and University of California Los Angeles School of Medicine, Cedars-Sinai Medical Center, Los Angeles (Dr Rimoin), Calif; Memorial Sloan-Kettering Cancer Center, New York (Dr Scheinberg), New York University School of Medicine, New York (Dr Catanese), and Columbia University, New York (Dr Johnson), NY; University of North Carolina School of Public Health, Chapel Hill (Dr Tilson); University of Arkansas College of Medicine, Little Rock (Dr Reece); Johns Hopkins University, Baltimore, Md (Dr Dobs); Yale University School of Medicine, Woodbridge, Conn (Dr Genel); Blue Cross/Blue Shield Association (Dr Korn); and Northwestern University, Feinberg School of Medicine (Dr Bonow), Chicago, Ill; University of Michigan School of Nursing, Ann Arbor (Dr Reame); Janssen Research Foundation, Titusville, NJ (Dr Grebb).

JAMA. 2004;291(9):1120-1126. doi:10.1001/jama.291.9.1120

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.