Implementing the CTSA vision: accomplishments and challenges

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Implementing the CTSA vision accomplishments and
challenges
David S. Guzick, MD PhD P.I. University of
Rochester CTSA Dean, UR School of Medicine
Dentistry
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Pre-CTSA

• Building blocks for clinical translational
  science
• Senior Assoc Dean for Clinical Research
• Expand Biostatistics and Bioinformatics
• Create cross-departmental programs and identify
  faculty leaders
• Research process improvement team
• Enhance Office of Technology Transfer
• Enhance GCRC
• Expand education and training through K30
• Create Research Resource Inventory

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Pre-CTSA

• GCRC
• Precursor began operations in 1940s
• One of 8 initial GCRCsfirst funded in 1960
• Since start of CTSA 14 increase in active
  protocols and 15 increase in first time
  Principal Investigators
• K30
• Funded in 1998 renewal in 2005
• 153 trainees accepted through 12/2007
• Results
• 75 completed 49 in progress 72 MPH degrees
  conferred
• 22 million in new grant funding
• 349 first author publications
• 15 individual K awards

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Research Resource Inventory
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Research Resource InventoryTranslational Research

• T1 Does this project involve applying basic
  science results to develop new diagnostic or
  therapeutic procedures in patients with specific
  health concerns?
• T2 Does this project involve testing the safety
  or efficacy of drugs or devices in specific
  patient groups?
• T3 Does this project involve testing drugs,
  devices or other interventions in community
  settings to establish effectiveness and
  efficiency?

Percentages reflect 1154 projects for which
responses were available, out of a total of 1388
research and other projects.
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CTSI Organization
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External leverage

• Clinical and Translational Science Building
• 1 University priority for 2007
• NYS Governor announced 50 million to support
  construction
• Upstate Consortium
• Pilot program funding - 150,000 contributed by
  Foundation for Healthy Living (Albany)
• IRB collaboration to simplify multi-institutional
  reviews
• National Clinical Research Associates
  supplemental grant from NCRR

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University of Rochester Medical Center
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Clinical Translational Science Building
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Site PlanTorque Scheme
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Aerial Perspective 4 Story Base
BuildingTorque Scheme, view toward southwest
Francis Cauffman
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Community Planning Diagram
Francis Cauffman
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Center for Governmental ResearchEconomic Impact
of the CTSA

• Total economic impact (steady state) 30
  million/yr about 600 jobs
• Building construction impacts
• - Labor income 43 million
• - 830 person-years of full-time labor

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Upstate New York Translational Research Network
Proposed new members Roswell Park, RPI
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CTSI Key FunctionUpstate New York Translational
Research Network (UNYTRN)

• Accomplishments
• UNYTRN Webpage
• Inventory of translational research and research
  resources
• Eight working groups convened
• Human Subjects Working Group developed memorandum
  of understanding to simplify multi-institution
  IRB submission
• Pilot Studies Working Group
• Solicited pilot study proposals (2/19/07), 10
  Applications received, 3 funded
• Total funds 170,000 (20,000 from CTSA,
  150,000 from Foundation for Healthy Living)

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Internal leverageAcademic impact

• Enthusiasm/Collegiality
• Active Key Functions - 45 faculty with effort on
  grant
• Willing volunteers e.g. gt80 reviewers for
  pilot study projects
• Training and Career Development
• 18 T32 trainees 7 K12 scholars selected (3 have
  now received other career dev. awards)
• Nanotech Symposium Stem Cell Symposium
• Mentor Development Program
• New Directions
• 8 pilot awardees 3 novel methods projects 8
  technology access awards 3 upstate consortium
  pilots

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Financial Challenges -Revised budget
guidelines -Carry-over process
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Impact of revised budget guidelines

• GCRC and K30 Budgets (2006) 2.8 million
• GCRC and K30 Budgets (2011) 3.4 million
• 0.8 million
• CTSA Re-budgeted (2011) 4.2 million
• __________________________________
• 4 escalation rate

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Financial Issues

• 2011 incremental funds 0.8 million
• 2011 CTSA needs
• K12 mentored career awards 1.5 million
• T32 training awards 0.8 million
• CTSA Key Functions ??

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Carry-over Issues

• Long delays (6 months) result in uncertainty for
  current projects awaiting carry-over approval
• Inability to plan for future years
• Inability to implement training, pilot, and novel
  methodology key functions
• Loss of momentum and enthusiasm

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University of Rochester Medical Center