ICTS: Strategic Directions for a
Winning CTSA Application
Gary E. Rosenthal, MD
Professor of Internal Medicine and
Health Management and Policy
Director, Institute for Clinical & Translational
Science
February 7, 2014
Goals of Presentation
1. Provide update on the CTSA reapplication
2. Obtain feedback on strategic directions
3. Identify areas of campus need with regard to
clinical and translational research (CTR)
4. Garner thoughts on identifying strategies for
engaging UI colleges and faculty and trainees
Presentation Overview
 50,000 Foot Overview  Rosenthal
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Historical perspective of CTSA program
National factors shaping the CTSA program
Changes in funding model and implications for ICTS
Future directions & key areas of program emphasis
 Review of Key Areas
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Community Engagement  Parker
Child Health  Widness
Clinical Research Support  Kline
Biomedical Informatics  Knosp
Education & Training  Nopoulos
Core Goals of ICTS
 Provide unique resources & services that
enable innovative research to improve human
health
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Education, training, & career development
Clinical and translational research (CTR) infrastructures
Methodological consultation and support
Pilot grants
 Support entire T1 – T4 spectrum of CTR
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T1  Lab discoveries to first in human studies
T2  Efficacy of new interventions in controlled trials
T3  Effectiveness of interventions in routine practice
T4  Impact of interventions on populations & policy
 Promote policies to improve CTR efficiency
Historical Perspective of
CTSA Program
 2006  CTSA initiative launched by NCATS
 2007  UI funded in 2nd cohort of grantees
 2011  NCRR disbanded & NCATS created as a
home for translational research in NIH & the CTSA
program
 2012  CTSA RFA significantly revised and IOM
Committee on the Future of CTSA Program
convened
 2013  Recommendations of IOM Committee
released
Major Recommendations of IOM
Report: Future of CTSA Program
1. Build on strengths of individual institutions
2. Emphasize innovative education and training
programs that are personalized to unique needs
of trainees and that promote team science
3. Build engagement of community members and
other key stakeholders in all phases of CTR
4. Strengthen CTR relevant to child health
5. Standardize evaluation processes that are built
around clear, consistent, and innovative metrics
Next Steps by NCATS for
CTSA Program
 2013  NCATS Advisory Committee established
to provide recommendations for responding to
IOM Committee / report anticipated in Spring
2014
 2013  CTSA Program governance revised
 Creation of new Steering Committee
 Streamlining of CTSA Consortium committee
 Decision to not release RFA & provide additional year
of funding to CTSAs with grants ending 4/14
 2014  New RFA anticipated by Summer with
application due 6 months later (? Jan 2015)
Changes in CTSA Funding Model
and Financial Implications for UI
 Initial funding formula based on funding levels of
legacy clinical research programs (GCRC, K30,
& K12)
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$6.9 million / year (total costs)
 New funding model introduced for January 2013
application  3% of total NIH funding of the
partnering institutions
 FY 2011 ($175 M)  $ 5.3 M / year (total
costs)
 FY 2013 ($145M)  $ 4.4 M / year (total
costs)
Key Strategic Directions
1. Focus resources on core areas that
maximize value to UI CTR enterprise
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Areas of increasing opportunity for external
funding
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Areas in which there are critical masses of
investigators who can successfully compete for
external funding
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Areas of need not being addressed by other
programs and centers
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Closely link ICTS resource allocations to program
evaluation data to maximize bang for the buck
Key Strategic Directions
2. Closer integration of ICTS with other UI centers &
offices & major initiatives in translational science
 Build on current joint initiatives with Holden Cancer
Center, CV Center, and CADRE that leverage
resources
 Build synergies with new high-impact programs (e.g.,
IIHG, Pappajohn Inst, Eagles Center, Wynn Institute)
 Link efforts with UIRF, Research Park, and Pappajohn
Center to more effectively promote entrepreneurship
 Broad buy-in for a CTSA program that meets
NCATS vision of an integrated home for CTR
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Next application should be story about CTR at UI!
Key Strategic Directions
3. Emphasize rural health as a unique strength
and nurture broad range of partnerships to
enable research to improve health of rural
Iowans
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Healthcare Providers  UI Health Alliance, UI child
specialty clinics
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Practice-based networks  FQHCs, CAHs, Irene,
Iowa School Nurses)
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Public Sector  IDH and DHS
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Other CTSAs  Midwest research network,
PCORnet
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Patient advocacy groups  CF Foundation
Key Strategic Directions
4. Enhance capacity in medical informatics to:
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Provide EMR data for CTR and enable investigators
to successfully compete for new funding from PCORI
and NIH for practice-based pragmatic trials
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Promote transformation of UIHC to a Learning Health
System in which ….
“science, informatics, incentives, and culture are
aligned for continuous improvement & innovation,
with best practices seamlessly embedded in the
delivery process & new knowledge captured as an
integral product of the delivery experience” (Institute
of Medicine, 2006)
Key Strategic Directions
5. Build capacity for conducting innovative
clinical trials
 Work with departments and research centers to recruit
experienced clinical trials
 Facilitate UI applications for participation in national
clinical trials networks (e.g., NINDS stroke network)
 Develop regional clinical research partnerships (e.g.,
MOU with Mercy Des Moines, MARCH network)
 Work with UIHC to incorporate ‘access to cutting-edge
clinical trials’ into hospital marketing strategies
 Create dedicated unit for conducting Phase 1 and
Phase 2 trials of novel therapeutic
Key Strategic Directions
6. Position UI with NIH & industry as a
preferred site for conducting clinical trials
 Capitalize on capabilities in Epic EMR to identify
eligible and recruit eligible subjects  Be a leader
nationally in subject recruitment
 Promote an efficient research environment regulatory
culture  Be a leader nationally in adopting
shared IRB & contract relationships & decreasing
regulatory barriers
 Implement the Iowa Heroes Subject Registry 
Increase awareness and access of Iowans to
clinical trials
Key Strategic Directions
7. Support the successful ‘K’ to ‘R’ transition of
junior investigators (~50 NIH K, institutional
K12, VA, and professional society career
development awardees) through K Clubs
 Professional development seminars
 Workshops to guide trainees through different
components of R01 type grants and to develop
competitive first submissions
 Mock study sections