G' Iris Obrams, M'D', M'P'H', Ph'D'

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G. Iris Obrams, M.D., M.P.H., Ph.D.
National Center for Research
Resources
NCRR Update 5 August 2006
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NIH Roadmap Re-engineering the Clinical Research
Enterprise

• From bench to bedside and from bedside to bench
  -- rapidly

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NIH Roadmap for Medical Research

• Developed to increase synergy across NIH
• Not a single initiative but over 345 individual
  awards in FY 2005
• 40 basic
• 40 translational
• 20 high risk

Non-Roadmap 99.2 (28,520 Million)
Roadmap 0.8 (237 Million)
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NIH Roadmap Strategy
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Clinical Enterprise
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Clinical Research Networks NECTAR

• NIH Roadmap National Electronic Clinical Trials
  and Research (NECTAR) Network
• Link existing networks so clinical studies and
  trials can be conducted more effectively
• Ensure that patients, physicians, and scientists
  form true communities of research

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NECTAR Inventory and Pilot Projects

• NECTAR Inventory current status of about 250
  clinical research networks and best practices
• http//www.ClinicalResearchNetworks.org
• NECTAR Pilot Projects have broad coverage
• Medical disciplines (cancer, heart, critical
  care, psychiatry, transplant)
• Populations/settings (primary care, rural,
  minority, HMO)
• Ages (pediatric, adult, geriatric)
• Information systems (data standards,
  informatics, tools, platforms)
• Geographic locations (U.S./global)

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NIH and the Presidents Health Information
Technology Strategic Plan

• Optimize Efficiency and Productivity of
  Biomedical Research
• Basic exploration
• Bioinformatics and computational biology
• Accelerate research translation
• Regional translational research centers
• Research IT systems
• NECTAR
• caBIG
• Vocabularies
• Standards

Transform Clinical Practice
Interconnect Physicians
Empower Patients
Improve Population Health
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CTSA, NECTAR Pilot Projects and Inventory of
Networks

• These are complementary programs CTSA focuses on
  academic institutions as homes for research,
  NECTAR focuses on linking organizations together.
• NECTAR Inventory identifies best practices for
  existing clinical network management. The NECTAR
  Pilot Projects explore how to combine and extend
  clinical networks.
• CTSA builds the homes for clinical and
  translational science. CTSA emphasizes internal
  and inter-institution nationwide interoperable
  informatics.

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Translational Science Awards (CTSA)

• Recent biomedical discoveries demand an evolution
  of clinical science
• CTSA awards will lower barriers between
  disciplines, and encourage creative, innovative
  approaches to solve complex medical mysteries
• New prevention strategies and treatments must be
  brought into medical practice rapidly
• The clinical and translational science awards are
  a way to catalyze change - breaking silos,
  breaking barriers, and breaking conventions

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Clinical and Translational Science Awards

• Create an institutional home and a distinct
  discipline for clinical and translational
  research at academic institutions
• Facilitate transition from basic translational
  research to improved patient care and public
  health
• Enhance interdisciplinary clinical and
  translational education and career development
• 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

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Forming Clinical and Translational Science Homes
Upgraded biostatistics
Upgraded informatics
Disease X Center
Clinical Research Design Incubator
IRB
Upgraded regulatory advice
GCRC
Translational cores
NECTAR NCRA
Training Programs
Disease Y Center
NIH RAID
Degree granting
K30 Curriculum
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NIH CTSAs Home for Clinical and Translational
Science
Clinical Research Ethics
Trial Design
Advanced Degree-Granting Programs
Biomedical Informatics
CTSA HOME
Industry
Participant Community Involvement
Clinical Resources
Biostatistics
Regulatory Support
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Biostatistics and CTSA Key Functions

• Performance of Innovative Translational Research
  Projects
• Development of Clinical and Translational
  Methodologies and Technologies
• Biomedical Informatics
• Design, Biostatistics, and Clinical Research
  Ethics
• Regulatory Support
• Participant and Clinical Interactions Resources
• Community Engagement
• Education, Training and Career Development and
  capabilities for Pilot and Collaborative Studies

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CTSA Funding

• Institutional Clinical and Translational Science
  Award RFA
• Approximately 30 M total to fund 47 awards in
  Sept. 2006
• Length of awards 5 years
• Up to 6 million in total costs per award per
  year in addition to combined current total costs
  of certain existing NIH awards (NCRR K12, K30,
  M01 Roadmap T32 and K12)
• To be reissued annually for additional centers
• Second RFA receipt date January 17, 2007
• Expand to 60 awards by 2012, costing in
  aggregate up to 500 M
• Funded by NIH Roadmap for Medical Research and
  existing NIH programs
• Planning Grant RFA for Institutional CTSAs
• One-time solicitation for one-year award
• 50 awards, 150K direct costs 11.5 M total

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DCRR Budget Expenditures
(Thousands)
plus Roadmap funds
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Transformation of the GCRCs

• GCRC reviews from now on conducted without site
  visits
• Only GCRC applications with already scheduled
  submission date accepted
• Last GCRC application submission date June 1,
  2007
• Successful GCRC applications receive 3-year award
  
• GCRCs with end date in 2008 may request 1-year
  extension
• GCRCs at successful CTSA applicant institution
  will become part of the CTSA
• Transformation process to CTSAs anticipated
  complete by September 30, 2010

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More Information
More Information
Visit the following websites http//nihroadmap.ni
h.gov/http//www.ncrr.nih.gov/clinicaldiscipline.
asp Contact Anthony R. Hayward, M.D.,
Ph.D.Director, Division for Clinical Research
ResourcesNational Center for Research Resources,
NIHTelephone 301-435-0790Fax
301-480-3661E-mail haywarda_at_mail.nih.gov