1 / 9

Optimizing Synergies CTSAs and ICs

Why should CTSAs be involved? . The CTSA Program was created to solve problems identified by clinical investigators:Lack of infrastructure and supportStudies take too long, cost too muchInvestigators engage in tasks for which they're not preparedRegulatory barriers

rune
Download Presentation

Optimizing Synergies CTSAs and ICs

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

    1. Optimizing Synergies CTSAs and ICs Mayo: need to review and overhaul entire system NIH HSREP awards – getting the process started Pfizer has unfavorable metrics for contract signing delays at AHCs compared with non-AHCs Major opportunities for getting improvements Eliminate waste Should AHCs be doing phase 3 protocols? AIDS protocols – Kagan – not only a US problem Overestimation of enrollment rate is problem. Really showing us that process analysis is important. NIH – at least NIAID – seems to be embarked on this. Ford wants additional data with view to process improvements. Re posting results, whose website? Identify institutions? What data? Averages? Type of study? Quality? Mayo: need to review and overhaul entire system NIH HSREP awards – getting the process started Pfizer has unfavorable metrics for contract signing delays at AHCs compared with non-AHCs Major opportunities for getting improvements Eliminate waste Should AHCs be doing phase 3 protocols? AIDS protocols – Kagan – not only a US problem Overestimation of enrollment rate is problem. Really showing us that process analysis is important. NIH – at least NIAID – seems to be embarked on this. Ford wants additional data with view to process improvements. Re posting results, whose website? Identify institutions? What data? Averages? Type of study? Quality?

    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 they’re 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”

    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 down: Steering Committee (PIs and NIH) identify a priority and create SGC to implement Bottom up: Key Function Committee identifies a priority and secures PI & Steering Committee approval. Outcomes must be evaluated

    9. Additional Support for CTSA 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

More Related