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CTSA Administrator Meeting

CTSA Administrator Meeting. October 2, 2007. Seamless Integration. Clinical Research. Translation and Adoption. Global Health. Discovery. Translation. Proof of Concept in Man. Clinical Development Phase II, III. FDA Approval Evidence Based Medicine. Practice Adoption,

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CTSA Administrator Meeting

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  1. CTSA Administrator Meeting October 2, 2007

  2. Seamless Integration Clinical Research Translation and Adoption Global Health Discovery Translation Proof of Concept in Man Clinical Development Phase II, III FDA Approval Evidence Based Medicine Practice Adoption, Practice Guidelines, Cost Effective • Community • Assessment • Care delivery • Outcomes • Economics Basic Discovery Preclinical Research; In Vivo Analysis PK,PD, Toxicology Improve Community Health Status Global Health: Service/ Research, Population/ Publication Current State Entities AHS/Industry/ Biotech Industry/Biotech HCS/Hospitals/ Practices/FQHC/AHS Clinical Research Organizations/AHS Government NGOs AMC/AHS AMC/AHS AMC/AHS AMC/AHS AMC/AHS AMC/AHS Basic Discovery Preclinical Research PD/PK/ Toxicology Proof of Concept In Man Phase II, III and IV Health Service and Outcomes Research Guidelines And Adoption Community Health Trends Global Health Research and Service DCRI DGHI DTRI DCCR New Timeline 10–12 years

  3. CTSA Governance and Leadership • DTMI Board • Chancellor for Health Affairs, CEO of Acute Care Services and CFO of Health System, Dean of SOM, Head of MD Practice Plan, Vice Chancellor for Corporate Research Development • DTMI Leadership Group • Faculty and Operational Leaders of Pillars and Core Resources • Key institutional officials (Director of Cancer Center, Director of Center for Genomic Medicine, CIO for Duke Medicine, Vice Chancellor for Corporate Research Development, Vice Dean for Research, Associate Vice Dean for Research Support Services, etc.)

  4. DTMI Governance and Leadership Guiding Principles • Small, lean core senior leadership group • High level of integration between CTSA leadership roles and institutional leadership roles. Key examples: • Exec Committee of DCCR is chaired by the SON Dean and includes the Director of Global Health Institute, Associate VP of Community Relations for Health System, etc. • Director of DTMI Biostatistics Core is also the Director of Biostatistics for the Cancer Center • Associate CIO for Clinical and Translational Medicine services is also DTMI Director of IT • Pilot Project Selection Committee overseen by School of Engineering Senior Associate Dean for Industrial Partnerships and Research Commercialization

  5. Barriers • Lack of transparency of other institutional commitments and risk of duplicating efforts • Concerns about “who gets credit” • Conflicts with departments regarding faculty effort and sharing of indirects • Silos

  6. Key Strategies • Co-investment in institutional strategic priorities with other entities (departments, centers and institutes) • Create federations to develop and adopt harmonized data standards • Financial transparency • Project management

  7. Cell and TissueTherapies ImmuneMonitoringandVaccines Chemistry andMolecularTherapies Project Management Biorepositoryand ‘Omics’ Imaging DTRI - Central Role of Project Management

  8. Successes • Key Hires/Appointments: • Director and COO • New DCRI Leadership team • Director, Finance & Business Strategy, Financial Analyst, Senior Grants Manager • Director, Regulatory Affairs • Manager, Regulatory Education and Training • 6 Project Leaders • Associate Director of Biomedical Informatics • Director of Operations and Research Manager for DCRU • 2 Senior Nurse Scientists for DCRU • Key leaders of Community Health Research Liaison Center, Training Center and Virtual Library

  9. Successes (continued): • Received $35M gift to fund MURDOCK Study in conjunction with North Carolina Research Campus • Roundtable meetings with key faculty in cell therapy and immune monitoring • Strategy sessions for each pillar and core resource to identify 4 year goals and investment plan for institutional commitment funds • Launched digital image management system for image-based clinical trials • Launched CRF library • Launched regulatory strategy consultation service • Launched statistical consultation service • Initiated centralized inventory of IND/IDEs

  10. The M.U.R.D.O.C.K. StudyThe Measurement to Understand Reclassification of Disease Of Cabarrus/Kannapolis Study

  11. Success (continued): • Implemented new structure for site-based research (organized investigators and study coordinators into formal groups by therapeutic area) • Operational restructuring of GCRC (integration of review process with eIRB, streamlined review process, creation of subject confinement area, etc.) • Implementing web-based system for pilot project application submission and review • Executed Memorandum of Understanding with FDA to host Public Private Partnership for Streamlined and Effective Clinical Trials

  12. Organizational Structure for Site-Based Research Group Chancellor/Dean Chairs/CSU Directors/Center Directors Department Administration SBR Director Faculty Advisory Board Principal Investigators Lead Study Coordinator Financial Manager Study Coordinators and Other Research Support Personnel

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