Clinical research in the United States at a crossroads: proposal for a novel public-private partnership to establish a national clinical research enterprise.
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.
Crowley
William F
WF
Harvard Medical School, Massachusetts General Hospital, Boston 02114 , USA. crowley.william@mgh.harvard.edu
Sherwood
Louis
L
Salber
Patricia
P
Scheinberg
David
D
Slavkin
Hal
H
Tilson
Hugh
H
Reece
E Albert
EA
Catanese
Veronica
V
Johnson
Stephen B
SB
Dobs
Adrian
A
Genel
Myron
M
Korn
Allan
A
Reame
Nancy
N
Bonow
Robert
R
Grebb
Jack
J
Rimoin
David
D
D000046:Academic Medical Centers / Q000458:organization & administration; D035843:Biomedical Research / Q000191:economics / Q000458:organization & administration*; D019058:Community Networks / Q000458:organization & administration; D003299:Cooperative Behavior; D006077:Government Agencies / Q000458:organization & administration*; D006282:Health Personnel / Q000458:organization & administration; D006296:Health Services; D007373:Interinstitutional Relations; D009316:National Institutes of Health (U.S.); D017149:Private Sector / Q000458:organization & administration*; D012108:Research Personnel; D012109:Research Support as Topic; D012952:Societies / Q000458:organization & administration; D014481:United States