Clinical Research in the United States at a Crossroads

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From JAMA 2004;291:1120-1126.

Vol. 291 No. 9, March 3, 2004

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

F. Crowley, Jr, MD; Louis Sherwood, MD; Salber, MD,

MBA;

Scheinberg, MD, PhD; Hal Slavkin, DDS; Hugh Tilson, MD, DrPH;

E. Albert Reece, MD, PhD; Catanese, MD; B. ,

PhD;

Dobs, MD, MHS; Myron Genel, MD; Allan Korn, MD; Reame, MSN,

PhD;

Bonow, MD; Jack Grebb, MD; Rimoin, MD, PhD

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.

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

), NY; University of North Carolina School of Public Health,

Chapel Hill (Dr Tilson); University of Arkansas College of Medicine,

Little Rock (Dr Reece); s 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).