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.