Title: Optimizing Synergies CTSAs and ICs
1CTSAs and Strategic Goals Going
forwards Clinical Research Management Tuesday,
June 23, 2009 Anthony Hayward
- Optimizing SynergiesCTSAs and ICs
2Why 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
3Clinical 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
4Coordinating the CTSA Committees
CTSA Steering Executive Committee s
CTSA sitePrincipal InvestigatorKFC
representativesAdminstrators
NCRRCoordinators
PI Liaisons
Key FunctionCommitteesNCRR Coordinators
5Coordinating 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
6CTSAs 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
7Examples 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
8Priority 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
9Additional 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
10NIH 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