Clinical
research is one of three goals that the agency will pursue as part of
the NIH “Roadmap” Initiative, introduced by Zerhouni
to identify elements of the research agenda that were not being addressed
by individual institutes and centers.
The other two areas singled out include an effort to boost collaborations
between different types of scientists and a plan to improve research and
technology related to proteins and small molecules that could be used in
drug development.
“Through these new initiatives, we hope to remove some of the biggest
roadblocks that are keeping research findings from reaching the public
as swiftly as possible,” Zerhouni said. “These efforts cover
a broad spectrum of points between the lab and the clinic — from
basic biological research, such as determining protein structure, to
the front lines of clinical research, such as improving the training
of the
physicians and nurses who run clinical trials.”
The Roadmap initiatives will be funded by a unique plan that pools resources
from all NIH institutes and centers. Zerhouni said that NIH will spend
$128 million on the Roadmap in fiscal year 2004 and close to $2 billion
to complete the initiatives.
Clinical research was “undoubtedly the most difficult but most important
challenge identified by the Roadmap process,” Zerhouni said, noting
that the success of the two other Roadmap areas would depend in part
on how fast they moved from the lab to the clinic.
The plan includes efforts to standardize clinical databases and patient
consent forms, improve training and attract more clinical researchers and
new technologies to measure symptoms like pain and quality of life that
are important for understanding chronic disease.
“There has been a scientific revolution in the last few years,” Zerhouni
said. “The opportunities for discoveries have never been greater,
but the complexity of biology remains a daunting challenge. With this
new strategy for medical research, NIH is uniquely positioned to spark
the
changes that must be made to transform scientific knowledge into tangible
benefits for people.”
Zerhouni said that the Roadmap will encourage more partnerships between
the NIH and patient and disease advocacy groups.