Colorado Clinical & Translational Science Award
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Colorado Clinical & Translational Science Award Colorado Clinical & Translational Science Award Presentation Transcript

  • Clinical and Translational Science Award University of Colorado Ronald J. Sokol, MD Program Director CU Program for Clinical and Translational Sciences April, 2007
  • Who I am?
    • Pediatric Gastroenterologist
    • Professor and Vice Chair of Clinical Research – Dept. of Pediatrics, School of Medicine
    • Program Director – Pediatric CTRC (GCRC)
    • Section Chief – Pediatric GI, Hepatology and Nutrition, CU SOM
    • Liver cell injury and death, cholestasis, mitochondrial pathways, oxidative stress, National Clinical Research Networks
  • NIH Roadmap
    • In 2002, Dr. Zerhouni charted a new “Roadmap” for Medical Research
    • Three objectives:
    • 1. New pathways to discovery
    • 2. Research Teams of the Future
    • 3. Re-engineering the Clinical Research Enterprise
    • In 2005 the Clinical and Translational Science Award (CTSA) program was developed
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  • Basic Research Clinical Investigation Clinical Trials Practice In the Community T1 Bench Bedside Trench Bidirectional Translational Research Molecules & Cells Patients Community & Population T2
  • CTSA Objectives: Speed Discoveries to Improved Patient Care
    • Develop a distinct discipline for clinical and translational science at institutions
    • Provide opportunities and resources for original research on novel methods
    • Develop translational technologies and a knowledge base for the full spectrum of clinical and translational science
    • Synergize partnerships with industry, foundations, and community physicians
    • Train the interdisciplinary teams who will conduct the clinical and translational research of the future
  • NIH CTSA Awards: A Home for Clinical and Translational Science Trial Design Advanced Degree-Granting Programs Participant & Community Involvement Regulatory Support Biostatistics Clinical Resources Biomedical Informatics Clinical Research Ethics CTSA HOME Industry Other Institutions
  • CTSA Eligibility
    • Domestic institutions, universities, academic health centers, or other organizations
    • A graduate school accredited to award higher degrees in clinical research must be included
    • Partnerships with independent and other research institutions are strongly encouraged
    • Institutions can only submit, or be part of, a single application
    • Evidence of significant institutional commitment
  • CTSA Funding
    • 60 awards by 2012, costing in aggregate up to $500 M
    • Budget = Combine certain current NIH grants + additional funds:
      • NCRR: K12, K30 , M01 (GCRC x 2)
      • Roadmap: T32 and K12
    • + up to $6 million in total costs per year
    • Length of awards: 5 years
    • GCRC program, K30 program, etc. will be phased out by 2011
  • FY2006 CTSA Funding Opportunities
    • RM-06-002 : Institutional Clinical and Translational Science Award (CTSA) RFA
    • RM-06-001 : Planning Grant RFA for Institutional CTSAs
      • Allows more time to prepare a CTSA application
      • One time solicitation for one-year award
      • ~50 awards, $150K direct costs; $11.5 M total
  • Current CTS Research and Training Strengths at CU
    • Many successful collaborative translational research efforts across campuses
    • Outstanding clinical research facilities (two General Clinical Research Centers and two satellites) and translational resources
    • One of first Clinical Science PhD and Masters programs in U.S.
  • UCDHSC CTSA Planning Grant
    • Submitted - Jan., 2006
    • Reviewed in July, 2006
    • Mark Geraci, MD – Principal Investigator
    • Funded – $150,000 direct costs $231,000 total costs
    • Major critiques:
      • Expand scope to include more collaboration with CU Boulder – Physiology, bioengineering, etc.
      • Evaluation process to assess outcomes resulting from infrastructure changes
  • Why a UCDHSC CTSA?
    • Must be part of CTSA national program to have a voice in CTS research, shape national programs
    • Ability to attract and retain outstanding faculty, trainees and physicians at all affiliated institutions
    • Provision of essential infrastructure, support and improved training
    • Be eligible for special RFAs and NIH funding
  • First CTSA Specific RFA
    • RFA-RM-07-006
    • Release Date: November 28, 2006
    • Limited Competition for Supplements to CTSAs to plan for pilot projects to apply the national clinical research associates model in their community engagement activities (UL1)
    • Concept of establishing cadres of community-based health practitioners trained to conduct clinical research as part of the Community Engagement component of their grants.  
  • Roadmap Funding (dollars in millions) Roadmap Initiative ~ 1% of NIH budget Totals on table may not add due to rounding 9/27/2005 2,179 507 520 448 333 239 132 Total 835 227 214 174 120 61 39 Clinical Research 396 93 96 92 44 43 28 Research Teams 948 188 209 182 169 135 65 Pathways to Discovery Total FY09 FY08 FY07 FY06 FY05 FY04
  • Roadmap Funding (dollars in millions) Roadmap Initiative ~ 1% of NIH budget Totals on table may not add due to rounding 9/27/2005 2,179 507 520 448 333 239 132 Total 835 227 214 174 120 61 39 Clinical Research 396 93 96 92 44 43 28 Research Teams 948 188 209 182 169 135 65 Pathways to Discovery Total FY09 FY08 FY07 FY06 FY05 FY04
  • 12 Funded CTSAs - 2006
    • Columbia University Health Sciences (New York, NY) Duke University (Durham, NC) Mayo Clinic College of Medicine (Rochester, MN) Oregon Health & Science University (Portland, OR) Rockefeller University (New York, NY) University of California, Davis (Davis, CA) University of California, San Francisco (San Francisco, CA) University of Pennsylvania (Philadelphia, PA) University of Pittsburgh (Pittsburgh, PA) University of Rochester (Rochester, NY) University of Texas Health Science Center at Houston (Houston, TX) Yale University (New Haven, CT)
  • Emerging Themes for Successful CTSA Application
    • Innovative and transformative
    • Collaborative and cooperative
    • Integrated across schools, campuses and hospitals
    • Heavy focus on training and education of new investigators in Clinical and Translational Research
    • Institutional Commitment
    • Academic Home
  • UCDHSC CTSA Structure
    • Schools of Medicine, Nursing, Dental, Pharmacy, Graduate School (Public Health)
    • UCDHSC, CU Boulder, CU Denver
    • Affiliated hospitals - UCH, TCH, DH, NJMRC, VAH, Kaiser Permanente
    • Graduate Training Programs
  • CTSA Planning
    • Executive Steering Committee (ESC)
      • Deans and Hospital Presidents, Paul Bunn, others
      • Oversight
      • Decision about Center/Institute
      • Appointments
  • Working Groups
    • 11 groups – integrated PhDs and MDs
    • Each focuses on one of the 9 components required by CTSA RFA + Evaluation + Child Health Research
    • Organized into 5 major Resource Programs (Divisions):
      • Discovery translation (bench to bedside research)
      • Community translation (bedside to trench)
      • Education and career development
      • Methods Development and Biotechnology
      • Child and Maternal Health Research
  • Nine CTSA Components (mandated by NIH)
    • New translational and clinical methods development
    • Regulatory knowledge and support
    • Design, biostatistics and clinical research ethics
    • Translational technologies and resources – -omics, biobanking, etc.
  • Nine CTSA Components - 2
    • Pilot and collaborative translational and clinical studies
    • Participant and Clinical Interactions
    • Translational informatics
    • Community Engagement
    • Research Education, Training and Career Development
  • Research training and education John Steiner Discovery Translation Robert Eckel Community Translation Andrew Kramer Methods Development And Biotechnology Mark Geraci Child and Maternal Health Research William Hay K30 MPH K12 T32 PhDs Adult and Pediatric GCRCs and satellites CTO CPC Drug Discovery Public Health Care Delivery Research networks Implementation Community engagement Methods development Pilot projects Technology Cores Integrating Research programs Biostatistics Informatics Regulatory Ethics CTSI or C Program Directors Board of Governors Evaluation
  • Governance
    • CTS Institute or Center
    • Board of Governors
    • External Advisory Committee
    • Internal Advisory Committee (CTRAC)
    • Director and 5 Co-Directors (for each major resource function)
    • Assistant Directors for components (Cores)
    • Hospital and Campus CTSA offices
    • Faculty membership – appointments
  • 2006-2007 Planning Phase
    • Working groups for each component
    • Each with representation from all 5 Schools at UCDHSC, Boulder and Denver Campuses and as many Hospitals as possible
      • develop Specific Aims, Background and current strengths, Areas for improvement, Methods to achieve aims, Integration and innovation, Timeline, Tracking and evaluation
    • Draft first draft for grant (15 pages each) by mid-May
    • Co-PDs to edit and blend
  • Timetable
    • Co-Directors
      • meeting biweekly
      • each Co-Director supervising 2-4 WGs
    • WGs to develop first draft by May, 2007
    • External Advisory Committee meeting end of May, 2007
    • Application Deadline: October 24, 2007
  • How participating Faculty will benefit from a successful application
    • New bridges across translational research barriers, across campuses
    • Core resources (e.g., biobanking) and expertise
    • Regulatory Support and Streamlining
    • Benefits of modern clinical research facilities and research nursing, nutrition, etc.
    • New Biostatistics, Informatics and Research Ethics UCDHSC Cores
    • New opportunities for trainees
    • Eligibility for new NIH RFAs – CTSA-specific
  • How participating Institutions will benefit from a successful application
    • Benefits of being part of a new alignment of regional/community assets
      • Savings due to new efficiencies – training, informatics, regulatory, repositories
      • Predictable enhanced competitiveness for every institution due to new translational research architecture
      • Community visibility, PR, and collaborative fundraising opportunities
    • Benefits of being a part of the broader NIH CTSA Collaborative
    • Benefits of sharing in CTSA award – e.g., institutional FTEs, core facilities,
  • Summary
    • CTSA application is tremendous opportunity to reshape clinical and translational research and training across University of Colorado, Affiliated Hospitals and Organizations
    • Will take a University-wide combined effort
    • Will require broad faculty and institutional commitments
  • Contact
    • [email_address]
    • Phone: 303-861-6669
    • Pager: 303-890-7744