http://stroke.ahajournals.org/content/44/5/1217.extract.html?etoc
Introduction
Stroke is the fourth leading cause of
death in the United States, and it is a major cause of long-term
disability and reduced
quality of life for hundreds of thousands of
Americans. Over the past decades, teams of National Institute of
Neurological
Disorders and Stroke (NINDS)–funded clinical
trialists have consistently made major contributions toward treating
stroke acutely,
enhancing its prevention and rehabilitation, and
thereby improving the health of the country. However, although stroke
research
has resulted in improved outcomes, the
increasing incidence with aging of the population and substantial
disability and mortality
associated with stroke remain a significant
burden for a growing number of stroke patients each year. At the recent
NINDS
stroke planning meeting, external clinicians and
researchers identified that enhancing clinical trial infrastructure is
one
of the highest priorities for the Institute to
address in its effort to advance stroke care in the United States.1
Recognizing the Challenges of Clinical Research
The NINDS typically funds between 20
and 50 phase II and III stroke trials, investing between $30 and $70
million per year.
Trials are generally funded in response to
investigator-initiated research proposals that are judged to be highly
meritorious
by a special clinical research peer review
committee. Before accepting trial grants for peer review, the NINDS
leadership
evaluates proposals for their potential to
reduce the burden of illness caused by stroke. The trials are performed
by large
teams self-assembled around single projects that
are championed by a principal investigator and a cadre of hard-working
co-investigators.
However, the execution of trials requires the
work of hundreds. Traditionally, necessary personnel and infrastructure
are
assembled anew for each trial once a grant
receives funding. Trial infrastructure is then disassembled once the
trial is completed.
Protracted negotiations over protocols and trial
agreements delay study start-up, increasing costs. In addition to the
inherent
inefficiency of time and resources involved in
duplication of infrastructure for each trial, the current system makes
it difficult
to continuously improve methods or
infrastructure based on lessons learned.
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