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. . . Regulatory Affairs. Education
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1. Duke CTSA: Goals and Objectives Core goal: form Duke Translational Medicine Institute, to serve as engine to accelerate translational research, home for Clinical and Translational Medicine discipline at Duke
4 Mission Critical Objectives:
1) accelerate translational research
2) train next generation of thought leaders
3) foster interdisciplinary relationships
4) improve health in Durham County, NC
4. CTSA Acceleration of Translation:Seamless Integration Let me summarize for you this talk into one slide. Earlier, I showed you a slide that demonstrated the current silos associated with moving a therapy from discovery to global application.
Now that Ive discussed the opportunity for seamless integration within Academic Health Systems, I want to show you what that continuum looks like.Let me summarize for you this talk into one slide. Earlier, I showed you a slide that demonstrated the current silos associated with moving a therapy from discovery to global application.
Now that Ive discussed the opportunity for seamless integration within Academic Health Systems, I want to show you what that continuum looks like.
5. Duke CTSA Evaluation:Conceptual Approach to Improving Quality of Research Structure/Process/Outcome Model
Structure is environment in which research takes place, process is methods of research, and outcomes are end results.
Continuous Quality Improvement (CQI) complementary team-based evaluation of processes.
6. Duke CTSA Evaluation: Example Structure Measures
7. Duke CTSA Evaluation: Example Process Measures
New programs/projects proposed to Duke TMI
NIH Grants / Sponsored Research ($ and #)
New INDs, IDEs, Patents
Number of students trained in Clinical and Translational Research
Number & Success of Start-up Companies
Important clinical trials, publications
8. Duke CTSA Evaluation:Example Outcome Measures Changes in key health status metrics for Durham County
Work leading to substantive changes in national practice guidelines
Work leading to FDA approval of new drugs/devices or new indications for approved drugs/devices