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Optimizing Synergies CTSAs and ICs

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Virtual Biobanks for Multicenter Research on Pediatric Rare Diseases ... Outreach to additional sites: IDeA states and other NIH programs ... – PowerPoint PPT presentation

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Title: Optimizing Synergies CTSAs and ICs


1
CTSAs and Strategic Goals Going
forwards Clinical Research Management Tuesday,
June 23, 2009 Anthony Hayward
  • Optimizing SynergiesCTSAs and ICs

2
Why should CTSAs be involved?
  • The CTSA Program was created to solve problems
    identified by clinical investigators
  • Lack of infrastructure and support
  • Studies take too long, cost too much
  • Investigators engage in tasks for which theyre
    not prepared
  • Regulatory barriers complexities are
    challenging
  • Lack of dedicated time for clinical research
  • The CTSA Consortium Strategic Plan identified
    National Clinical Translational Research
    Capability as its 1 Priority

3
Clinical Research Management a Priority
  • CTSA program has run for 2 yrs 9 months
  • Protocol activation issues identified at outset
  • Many institutions start internal evaluations
  • Clinical Research Management prioritized 2007
  • Creation of CRM workgroup, first as subgroup of
    Regulatory Knowledge and then as KFC
  • CRM linked with Regulatory and PCIR KFCs in 2009
    as Clinical Innovation

4
Coordinating the CTSA Committees
CTSA Steering Executive Committee s
CTSA sitePrincipal InvestigatorKFC
representativesAdminstrators
NCRRCoordinators
PI Liaisons
Key FunctionCommitteesNCRR Coordinators
5
Coordinating the CTSA Committees
Strategic Goal
Key Function
National Clinical and Translational Research
Capability
Clinical Innovation
Research education, training, career development
Training Career Development of
Clinical/Translational Scientists
CTSA Steering Executive Committees
PI Liaisons
Enhancing Consortium-Wide Collaborations
Informatics
6
CTSAs and the strengths of a Consortium
  • Willingness to speak with one voice
  • Post performance, peer pressure the gold star
    reflex
  • Change community expectations through leadership
  • Share experiences and successes
  • Opportunity to form goal-driven subgroups

7
Examples of goal-directed CTSA groupings
  • Informatics projects
  • University of Washington, UCSF, UCDavis, Oregon
    HSU
  • Oregon HSU, Mayo, Vanderbilt
  • U. Wisconsin, U. Michigan, Case Western
  • Clinical Research Scholars
  • West Coast
  • Midwest
  • New York Yale
  • Strategic Goal directed projects

8
Priority Setting Mechanisms for CTSA Consortium
Activities Criteria and Decision-making
  • Top downSteering Committee (PIs and NIH)
    identify a priority and create SGC to implement
  • Bottom upKey Function Committee identifies a
    priority and secures PI Steering Committee
    approval.
  • Outcomes must be evaluated

9
Additional Support for CTSA Projects
  • Administrative supplements
  • 2008 2.5 million to support consortium-wide
    projects
  • Informatics National web portal for research
    volunteers
  • Virtual Biobanks for Multicenter Research on
    Pediatric Rare Diseases
  • CTSA National Resource Database for Translational
    (T1) Research
  • 2009 5M for Research on Outcome Measures for
    Pediatric Clinical Trials NOT-NCRR-09-005
  • 2009 Approximately 60M of ARRA funds

10
NIH goals for CTSA program
  • Have 60 CTSAs by the end of 2011
  • Provide a safe environment for human subjects
    research
  • Obtain objective evidence to judge the success of
    the program
  • Outreach to additional sites IDeA states and
    other NIH programs
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