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AAMC Reporter: February 2009
CTSA Program Links Researchers, Spurs Discovery
This winter and spring, the National Institutes of
Health (NIH) are announcing the next round of recipients of its
Clinical and Translational Science Awards (CTSA). By 2012, the NIH
plans to create about 60 CTSAs—there are currently 38—that will
work both in local and regional consortia, and as a national network,
to advance clinical and translational science.
Created in 2006, the CTSA program is intended to streamline
the disparate offices within a research institution, then bring
institutions together to form consortia dedicated to working on
major health care challenges—a task that is easier said than done
given the traditionally self-contained nature of many research centers
and their component divisions. More specifically, the program's
primary goals are to shorten the time it takes for laboratory discoveries
to move from "bench to bedside," or from the laboratory itself to
a place where the discovery can begin to help patients; train the
next generation of clinical and translational researchers; and engage
communities in the clinical research process.
Each CTSA, led by an academic medical center, involves
many local collaborators—often a dozen or more—ranging from hospitals
and research institutes to health plans, community-based organizations,
school systems, and businesses. Nationally, the CTSA consortia keep
in touch and share experiences through program connections.
"One of the major accomplishments of the CTSA is the
development of a viable, active network among major academic research
centers," said Irena Tartakovsky, M.D., AAMC senior science policy
analyst. "The CTSAs have frequent conferences, discussing challenges
and opportunities in each institution and sharing best practices."
For young clinical researchers, the CTSAs provide
a "home" within the medical center that many have never had before.
Research facilities are better connected within an institution,
which provides a clearer professional track for young investigators.
"Unlike for Ph.D. basic scientists, there has not
been a clear, delineated path for young physicians who want to pursue
clinical research," said Stephen Heinig, AAMC lead science policy
analyst. "Now, the head of the CTSA must commit to and care for
the young people pursuing clinical research within the consortium."
All is not rosy for the CTSAs, however. The recession
and tighter belts in Washington have hit the program hard. A July
report in the Chronicle of Higher Education noted that many of the
14 awardees from earlier that year will receive significantly less
funding than originally promised. Tufts University School of Medicine,
for example, is now on schedule to receive an award of $20 million
over five years, or less than half of the $42 million it requested.
Institutions have announced fundraising drives to fill the funding
gaps and are asking for permission to recalibrate the scope of their
plans.
The CTSAs are still too new—the first round of grants
was awarded in 2006—to point to major clinical advances that occurred
as a result of their creation. But Anthony R. Hayward, M.D., Ph.D.,
who directs the CTSA program, said that changes may be coming soon.
"Recently, the 38 CTSA recipients got together to rethink their
strategic goals, and one top priority was speeding up the implementation
of clinical trials," he said. "The time between a protocol dropping
through the mailbox and getting your first enrollee can be one year,
two years, or nine years—unbelievably long. The CTSA sites are now
running metrics on themselves to see how long it really does take,
and to identify what the roadblocks are."
A key part of the CTSA mandate is community involvement.
A major roadblock to enrollment in community trials has been complaints
from community residents that researchers come into their neighborhoods,
conduct their research, and leave—and local people never see the
benefit.
"Now, with the CTSAs, the schools form stable relationships
with community leaders," Tartakovsky said. "The community is involved
in making decisions about what research is planned, and how that
community will benefit from the research is discussed from the outset."
One CTSA with an extensive commitment to community
engagement is the Duke Translational Medicine Institute, which received
one of the first 12 CTSAs in 2006. Duke is now exploring myriad
ways to partner with county organizations with the explicit goal
of improving community health.
"We're spending $1 million in planning money alone
over a year to get data about health needs in Durham from the health
department and other community agencies, to find out what we can
make a difference on," said J. Lloyd Michener, M.D., clinical professor
and chair of Duke's department of community and family medicine.
"How can we redesign the way we deliver care at Duke so health is
improved? We're willing to change anything. We've received 22 applications
from 90 community organizations to do a detailed analysis of what
it will take to make the people of Durham healthier than the average
Cuban—which actually is a stretch for us as a county."
Amid economic difficulties with the program and throughout
the entire nation, there is hope that the CTSAs could act as drivers
of economic improvement in their areas.
"If you look at what drives employment in states,
it's often health care. You can be developing new businesses, new
biotechs, new medical research labs," said Barbara Alving, M.D.,
director of the National Center for Research Resources, which oversees
the program. "In Indiana, for example, Purdue and Indiana University
have developed a CTSA, and now a commercial group called Biocrossroads
is interested in working with them, as well as Eli Lilly. CTSAs
seem to scoop up whatever is relevant in their geographical area,
and move innovation forward."
—By Gina Shaw, special to the Reporter
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