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NerveCenter CTSA program continues Сon trackТ despite backlog.

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CTSA Program Continues ‘On Track’ Despite Backlog
As the Clinical and Translational Science Awards
(CTSA) entered their fourth year, the overall goal of
converting insular research “silos” into much broader,
multidisciplinary collaborations is slowly being realized,
despite recent concerns that the program would lose
momentum under several years of a slack budget at the
National Institutes of Health (NIH).
Passage of President Obama’s economic stimulus
package, which earmarked $10.4 billion for the NIH,
is an encouraging sign that should calm concerns of
any further erosion of research funding, at least in the
short-term. In addition to its existing $29 billion budget, the total NIH budget is nearly $40 million – the
highest level ever.
The funding turn-around has buoyed hopes that
funds for newer CTSA participants will be larger in the
years to come. For the past two years, annual funding
for CTSA institutions has been limited, with many
schools receiving far less than requested for their programs each year – especially first-year awardees.
In early April, the University of Cincinnati became
the 39th institution to receive a CTSA, the first award
made to date since the Administration’s stimulus package was enacted. The $22.7 million award, to be doled
out over five years, was just the first to be made this
year — others will be awarded later in 2009 under a
special two-tier review process that the National Center
for Research Resources (NCRR) instituted temporarily
due to the current backlog of applications, according to
the agency charged with administering the program.
The NCRR has reassured applicants and current CTSA
researchers that the current delay in reviewing awards is
“temporary,” and that it remains on track to award the
full $500 million CTSA authorization by 2012.
Any 2009 applications considered in the first review
process that did not receive an award will automatically be
considered in the second round, the agency said. It will
return to its former one review cycle in FY 2010. The
next round of applications, which must be submitted by
Oct. 14, 2009, are expected to be awarded in July 2010.
Before the NIH budget increase, a number of academic research leaders had expressed concern about the
future of academic translational science initiatives without more funds for the NIH. One special concern has
been that newer CTSA recipients have had to work
with less funding for initial infrastructure changes.
Annals of Neurology
Under the original NIH formula, institutions were
able to seek up to $30 million over five years, but the
agency revised this in October 2007 when noncompeting renewal awards were limited to increases of between 35-45 percent. Many CTSAs responded by requesting that they be allowed to modify the scope of
their original pilot designs.
CTSA Awards 2009
University of Cincinnati
CTSA Awards 2008
Five-year Funding Total:
Albert Einstein College of Medicine of Yeshiva
Five-year Funding Total:
Boston University
Five-year Funding Total:
Harvard University
Five-year Funding Total:
Indiana University School of Medicine
Five-year Funding Total:
Northwestern University
Five-year Funding Total:
The Ohio State University
Five-year Funding Total:
The Scripps Research Institute
Five-year Funding Total:
Stanford University
Five-year Funding Total:
Tufts University
Five-year Funding Total:
The University of Alabama at Birmingham
Five-year Funding Total:
University of Colorado Denver
Five-year Funding Total:
The University of North Carolina at Chapel Hill
Five-year Funding Total:
The University of Texas Health Science Center at
San Antonio
Five-year Funding Total:
The University of Utah
Five-year Funding Total:
2007 Awards
Case Western Reserve University
Emory University
Johns Hopkins University
University of Chicago
University of Iowa
University of Michigan
University of Texas Southwestern Medical Center
University of Wisconsin, Madison
University of Washington
Vanderbilt University
Washington University in St. Louis
Weill Cornell Medical College
2006 Awards
Columbia University
Duke University
Mayo Clinic
Oregon Health & Science University
The Rockefeller University
University of California, Davis
University of California, San Francisco
University of Pennsylvania
University of Pittsburgh
University of Rochester School of Medicine and
University of Texas Health Science Center at
Yale University
“Unlike the previous RFAs, it’s very clear in the new
RFA that there’s only $4 million available, so no one
will get their expectations too high,” notes Ira Wilson,
a professor of medicine at Tufts University and a researcher with the school’s CTSA. “It’s a lot of money,
but not when you are implementing infrastructure
changes on this scale.”
Tufts received a $20 million CTSA in 2008, half
what the school had sought. Its first-year funding was
limited to $4 million. Another 2008 recipient, Albert
Einstein College of Medicine of Yeshiva University, in
New York, received $22 million rather than the $59
million it requested, and many 2007 and 2006 awardees received less funding than requested in their noncompeting renewal awards in 2008.
Wilson likens the budget situation to a lending
shortfall when building a house.
“Imagine that the building plan calls for $500,000.
You buy the land, pour the foundation and put up the
walls and roof, then find out the lenders will only give
you $250,000. If we had known this from the beginning at Tufts, we could have planned differently – we
could have built a smaller house. These cuts have been
pretty discouraging. A lot of promises were made to
researchers that can’t be kept.”
The $4 million awarded the Tufts CTSA does not
accurately reflect the amount that will eventually be
available for research, he adds, noting that after indirect institutional costs, the researchers will end up with
about $2.5 million.
A lack of funding can quickly reach “critical mass,”
and scuttle a nascent CTSA, warns Wilson.
“Each CTSA has to receive enough money to get up
and running, and that has not happened yet. I’m
pretty sure everyone would agree that the CTSA cuts
have put at risk the core components of the programs
at each site – there hasn’t been enough money to build
the necessary infrastructure for them to succeed in their
mission. The risk of under funding means the programs don’t get any traction early on.”
In addition, many academic researchers changed career directions in order to take advantage of the CTSA
initiative and are now concerned that funding levels
may fall even further, he says. “Right now it’s a halfbuilt house, and researchers are afraid they will be left
hanging with their projects, with no option but to return to the earlier research system.”
Growing Pains
This past January, when NIH issued its request for applications (RFA) for the next four CTSA sites, it specified that $4 million would be made available for each
institution during the first year. It remains unclear
whether or not subsequent awards will be higher. Some
researchers argue that building an institutional translational science program requires more initial funding.
Breaking Silos
According to Anthony Hayward, Associate Director of
Clinical Research at NCRR, the CTSA program has
already made significant changes to the academic research landscape.
Not only are numerous research projects underway
at participating institutions and community partners,
Annals of Neurology
but regional networks of CTSAs are meeting regularly
to share tips and exchange ideas for improving cooperative research efforts.
Designed to promote inner- and inter-institutional
cooperation in the development of new therapies,
CTSAs also encourage greater community involvement
in research while grooming the next generation of
translational clinical researchers.
“Our intention is to provide a one-stop shop for all
clinical and translational researchers, especially junior researchers and trainees considering career directions,” says
Hayward. “CTSAs have given out a lot of money for
pilot studies and serve as advocates in many areas, including developing proposals for Institutional Review
Boards. Our aim is to get better clinical research information, and by having a consortium it allows everyone
to share ideas and speak with one common voice.”
NCRR Director Barbara Alving is equally enthusiastic about the program’s progress to date.
Speaking at a CTSA symposium at the University of
Delaware in early May, she cited several early successes,
including the statewide expansion of an electronic medical record system developed by a CTSA in Indiana, and
a CTSA partnership between a neurologist and a biomedical engineer at Columbia University, in New York,
that has quickly led to development of a device to help
children with spinal muscular atrophy (SMA) better use
their remaining limb strength. (see sidebar).
According to Alving, CTSAs have also created national and regional research communities, partnerships
providing opportunities for members to share and “leverage” local resources, as well as supporting pilot
projects for young investigators and building novel relationships with business schools.
She acknowledged that creating a national network
of CTSAs sharing information, one of the program’s
goals, will be a difficult process. First CTSAs have to
organize themselves, then work with each other and
with the NIH.
NCRR has provided additional funding for developing these networks of CTSA sites, as well as money for
researchers to develop informatics pilots for small to
medium-sized clinical studies carried out by groups at
three institutions or more, Alving noted.
Several cooperative CTSA research websites are already in place. At Harvard University, the Catalyst
website links 10 institutions and 18 medical centers
with public, private, and community partners. Users
can locate and communicate with other researchers and
potential trial subjects, exchange ideas and opportunities, and share information on available resources in
their area. A similar project at Vanderbilt University
Medical Center, the StarBRITE (Biomedical Research
Integration, Translation and Education) portal, is an
interactive system providing “one-stop shopping” for
researchers’ needs.
Annals of Neurology
Partnered Solutions
At Columbia University’s Pediatric Neuromuscular Clinic, Petra Kaufmann works with
children with SMA, the genetic disorder that
causes extreme weakness and deterioration of the
arm and leg muscles.
In 2007, she had a brainstorm. She envisioned
some sort of new mechanical supportive device that
would help her young patients use the limited muscle strength in their arms. Kaufmann called a colleague in the biomedical engineering department to
discuss her idea, and together they worked with
others to design and build the tool. Today, the device has been developed and is already helping a
number of SMA patients, she notes.
“It never occurred to me to reach outside my discipline to find a collaborator to build an apparatus
to help children with SMA until I saw an announcement for an interdisciplinary pilot grant
funded by the Irving Institute for Clinical and
Translational Research here,” says Kaufmann, associate director of the clinic.
In just two years, Kaufmann’s idea has become a
reality. A $25,000 six-month interdisciplinary
CTSA pilot planning grant in September 2007 was
followed by a second phase award of $125,000,
with which she and her colleagues have developed a
working prototype.
The CTSA at Columbia University in New York supported development of this prototype of a device to help
spinal muscular atrophy patients use their arms.
Building Bridges
Richard A. Rudick, vice chair of the Neurological Institute at the Cleveland Clinic and CTSA co-principal
investigator, has been involved with the program from
the early planning stages as a member of the NCRR
CTSA council member.
He too says the CTSA initiative has already started
to accomplish its goals, and he is optimistic about what
he calls the “forced marriage” between different disciplines and institutions under the program.
“We haven’t seen the full impact yet, but it will be
big. It will force a lot of inter-institutional collaboration
that has never been done before. Because the total number of CTSAs that will be awarded when all is said and
done is limited to 60, that means there will likely only
be one for every major city, so academic researchers in
any given city will be affected in some way or another.”
Dr. Rudick, whose research focuses primarily on
multiple sclerosis, says eventual development of a nationwide CTSA consortium is likely to result in novel
initiatives to reduce redundancy and delays in clinical
research through a more integrated regulatory environment. At the same time, CTSAs will give rise to educational and training standards for core competencies,
possibly within ten years, he predicts.
In 2007, E. Ray Dorsey, an assistant professor of
neurology at the University of Rochester Medical Center, received a K12 grant from the school’s CTSA to
extend his study of productivity in private and publicly
funded neuroscience research.
Through the school’s CTSA he was able to collaborate with a number of noted researchers at other CTSA
sites, including Cornell University and the University
of California, San Francisco. The collaboration, which
has resulted in several published studies in major journals, would not have been possible without the Rochester CTSA, he says.
“For me, the CTSA provided an opportunity to expand my network of collaborators and broaden the
scale of my research. For junior investigators, this is
extremely important.”
Columbia University College of Physicians and Surgeons, in New York City, was one of the first CTSA
recipients in 2006. The school’s Irving Institute for
Clinical and Translational Research of Columbia University Medical Center (CUMC), however, has been
involved for over 30 years, notes Karen Marder, the
Sally Kerlin Professor of Neurology and Psychiatry and
Chief of the Division of Aging and Dementia.
The Institute has ten resources currently in place to
support clinical and collaborative translational research,
she notes, including a master’s degree in patientoriented research for postdoctoral fellows and junior
faculty, a certificate in clinical/translational research for
predoctoral students, K12 grants for young investigators, and other short-term courses and career development opportunities.
The Institute has also recently developed an interactive informatics system, called WorkWeb, that uses onA12
line social networking to enable investigators throughout Columbia University and its CTSA to identify
others working on similar or related research and thus
spark innovative, multidisciplinary collaborations.
“Neurology has always been very visible and active at
the Irving Institute in terms of protocols funded by
[National Institute of Neurological Disorders and
Stroke (NINDS)] and the National Institute on Aging,” Marder says. “Today we have over 25 neurological researchers involved in one way or another – this
includes 20 percent of all outpatient protocols and includes Alzheimer’s, Parkinson’s disease, multiple sclerosis and neuro-oncology, including in- and outpatients.
We’re also involved in a lot of large community-based
epidemiological studies in aging and stroke.”
One of the most exciting of these, she continues, has
been placing CTSA research coordinators in emergency
departments and intensive care units to recruit subjects,
facilitate neurological research, and help young investigators.
“The [emergency department] and ICU doctors are
so busy doing clinical work that they don’t have time
to develop protocols or administer research projects.
That’s where the CTSA comes in,” she says.
There are special coordinators in the adult neurological and neurosurgical ICUs, surgical ICU, coronary
care unit, pediatric ICU, and neonatal ICU, as well as
in the adult and pediatric emergency departments. Coordinators submit Institutional Review Board applications for approval to perform human research, recruit
participants, collect data, and educate participants and
staff about ongoing research.
Marder’s team is working with 40 new investigators
managing 73 new protocols, more than half of which
are in ICUs or emergency departments. Research topics
range from the use of anesthesia in the surgical ICU to
the effects of temperature in serious brain injury patients.
The CTSA has also developed joint research projects
with ICU doctors. One proposal under consideration
involves studying continuous ECGs of patients in the
ICU setting, looking for different risk factors for nonconvulsive status.
“We are all concerned that budget cuts are possible,
but we have tried to build on our existing infrastructure,” says Marder, adding that the Institute is part of
a regional consortium other CTSAs called NYCON
that get together to share ideas, resources and other
Two similar groups have also formed in other regions. The Universities of California, San Francisco
and Davis, together with Oregon Health and Sciences
University and the University of Washington, have
formed the CTSA West Coast Consortium, and there
is an Upper Midwest Alliance representing nine regional CTSAs, including the Mayo Clinic.
Annals of Neurology
Neurologists Needed
According to Walter J. Koroshetz, Deputy Director of
the NINDS, academic neurological researchers and
neuroscientists need to understand the importance of
being involved early-on in the development and leadership of CTSAs or risk having their research interests
under represented in the long run.
“Down the road, the structure of an institution’s CTSA
will depend on who is involved from the start, and the
disciplines they represent,” he says. “There is a great need
for neurological leadership within CTSAs, and neuroscientists should try to get involved during the start-up
phases to make sure neurology is represented in future research decisions and the discussions leading up to them.”
One thing that is clear is that CTSAs are around to
stay, he emphasizes. “The question for neurologists and
clinical neuroscientists is how to secure a place in the
infrastructure. The biggest problem is if they aren’t
even thinking about it yet.”
At Tufts, Wilson agrees.
“Researchers can’t afford to have a wait-and-see attitude about CTSAs. It’s quickly becoming clear that
there is a division between the haves and the have-nots.
Unless you’re in a CTSA, you’re not really in the
game, you just won’t have access to the infrastructure.”
Late last year, S. Claiborne “Clay” Johnston became
the new director of the CTSA at the University of California, San Francisco, School of Medicine, the first
neurologist to lead a CTSA. Johnston is a professor of
neurology, epidemiology and biostatics, and director of
the UCSF Stroke Service. He is also Executive Vice
Editor of Annals of Neurology.
Johnston has played a leading role in developing the
NCRR CTSA WIKI network. The interactive website
allows researchers at CTSAs and their partnering institutions to access the central site, as well as those hosted
by individual centers.
“I envision a CTSI that spawns a long series of
projects or initiatives that are of broad relevance to
research, similar to how a venture capital organization
identifies and funds new businesses,” Johnston said in
a letter to the UCSF community. “Identifying opportunities to change the way research is done nationally
and worldwide, and not just at UCSF, is essential,”
he wrote.
Kurt Samson
in the Annals...
Over the past three years, high-dose barbiturate therapy has been used in the treatment of 60 patients with head
injury (N ⫽ 45), encephalitis (N ⫽ 8), acute focal cerebral ischemia (stroke, N ⫽ 4), and global anoxia secondary to
drowning (N ⫽ 3). High-dose barbiturates appear to be useful adjuncts in the control of intracranial hypertension
refractory to other methods of therapy. Administration of barbiturates to patients with this problem will often reduce
the requirement for osmotic agents, thereby facilitating medical management by avoiding hyperosmolality and fluid
and electrolyte depletion. In a carefully controlled intensive care setting the risk of barbiturate therapy is low, though
the costs and demands on personnel are great. Survival appeared to be improved in patients with head injury and
encephalitis. Although the ultimate outcome was not altered in patients with stroke or near-drowning, intracranial
hypertension did not occur until barbiturate therapy was withdrawn. This experience provides an ethical basis to
justify further randomized studies for determining whether or not barbiturates materially improve the neurological
outcome following cerebral ischemic and traumatic insults.
Annals of Neurology
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