Optimizing Synergies CTSAs and ICs

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CTSAs and Strategic Goals Going
forwards Clinical Research Management Tuesday,
June 23, 2009 Anthony Hayward

• Optimizing SynergiesCTSAs and ICs

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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

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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

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Coordinating the CTSA Committees
CTSA Steering Executive Committee s
CTSA sitePrincipal InvestigatorKFC
representativesAdminstrators
NCRRCoordinators
PI Liaisons
Key FunctionCommitteesNCRR Coordinators
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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
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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

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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

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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

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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

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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