The NIH roadmap: the future of clinical research growth and success at UK

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The NIH roadmap the future of clinical research
growth and success at UK

• John Novak BDS, LDS, PhD

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It is the responsibility of those of us
involved in todays biomedical research
enterprise to translate the remarkable scientific
innovations we are witnessing into health gains
for the nation
From Bench to Bedside
Elias Zerhouni, MD Director, NIH NEJM 2005
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NIH roadmap initiatives

• New pathways to discovery (bench science)
• New approaches to unravel the complexities of
  biologic systems (proteomics, metabolomics, new
  tools/probes)
• Research teams of the future (bedside science)
• Promotion of interdisciplinary research and
  training
• Removing barriers to interdisciplinary research
• Promoting public-private sector liaisons
• Re-engineering the clinical research enterprise
• Creation of research networks
• Clinical research workforce training
• Translational research bench to bedside teams

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Challenges of Clinical Research

• Explosion of in service demands for clinicians
• Lack of resources to support clinical research
• Difficulty in recruiting, mentoring and training
  clinical researchers
• Lack of integration of bioinformatics, bench to
  bedside laboratories, and statistical cores

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Challenges of Clinical Research

• Currently, NIH spends approximately 36 of its
  budget on clinical research and training
  activities. Yet these concerns persist and more
  must be done
• Zerhouni NEJM 2005

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What needs to be done?

• Expand the training for clinical and
  translational scientists
• on the job training is insufficient
• Specific clinical/translational training programs
• Clear path for promotion and tenure for clinical
  and translational scientists
• Create integrated academic structures
• Dedicated facilities
• Doctoral degree programs
• Integration of academic silos
• Create new bridges across scientific fields

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Following the Roadmap

• Step 1
• Institutional Clinical and Translational Science
  Award (CTSA RFA U54 mechanism)
• Direct application for full award
• Planning application
• Due March 27, 2006 (and yearly thereafter)
• Full awards
• 30 million available for FY 2006
• Up to 6 million in total costs for 5 years
• 4-7 awards for FY 2006 for full award
• Planning awards
• 11.5 million available for FY 2006
• 50 awards for FY 2006

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Purpose of CTSAs

• Serve to concentrate basic, translational and
  clinical investigators, community clinicians,
  clinical practices, networks, professional
  societies and industry
• Couple with advanced degree programs
• Requires significant institutional support
• Granted status as major administrative entity
• Requires true Academic Home
• center, department or institute

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Key Functions of CTSAs

• Innovative clinical/translational research
• Inclusion of clinical and basic scientists
• Biomedical informatics
• Design, biostatistics, research ethics
• Regulatory knowledge and support
• Participant and clinical interactions resources
• Community engagement
• Education and training (MS or PhD)
• Communication with other centers and industry

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Overall approach for CTSA

• Need to describe how CTSA will transform clinical
  and translational research at their institution
• Faculty, staffing and direction of home for
  clinical research
• Existing institutional resources for the CTSA
• Specific institutional commitments to CTSA
• Support for new home for clinical research

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Impact of CTSAs

• Funding for GCRCs will be phased out over next
  3-5 years.
• Functions of GCRC will be included in CTSA
• Lack of Institutional Commitment will impact
  applicant institutions
• No home no award
• Will require interdisciplinary interaction
• Academic and clinical silos will need to come
  together
• Will require closer collaboration between basic,
  translational, and clinical scientists
• Lack of an Institutional CTSA will impact future
  applications to NIH

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How is UK positioned for an application?
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The Planning Process

• Clinical Research Summit
• September 9, 2004
• Clinical Research Task Force
• Assignments, November 9, 2004
• Final report, November 10, 2005
• Topics addressed
• Institutional policies and procedures
• Operational norms for clinical research
• Roles, relationships and coordination among UK
  units
• Investigator issues

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What Should We Have in Place?
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Research Structure
Clinical/translational Research Home
Long-term Sample Banking
Epidemiologists Biostatisticians
Proteomics
Proteomics
Bioinformatics
Basic Science Research
Data Management
Data and Safety Monitoring Board
Genetics
Clinical Research Support/training
Clinical site
Clinical site
Clinical site
All connections facilitated by an electronic
information system
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What Do We Have in Place?
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Research Structure
Clinical/translational Research Home
Long-term Sample Banking
Epidemiologists Biostatisticians
Proteomics
Proteomics
Bioinformatics
Basic Science Research
Data Management
Data and Safety Monitoring Board
Genetics
Clinical Research Support/training
Clinical site
Clinical site
Clinical site
All connections facilitated by an electronic
information system
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What Do We Need to Develop?
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Research Structure
Clinical/translational Research Home
Long-term Sample Banking
Epidemiologists Biostatisticians
Proteomics
Proteomics
Bioinformatics
Basic Science Research
Data Management
Data and Safety Monitoring Board
Genetics
Clinical Research Support/training
Clinical site
Clinical site
Clinical site
All connections facilitated by an electronic
information system
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Timeline for Implementation
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Recommended Timeline for Implementation

• Winter 2006
• Town meetings
• Advisory committee for clinical research
• Spring 2006
• Alignment of UKCRO and GCRC
• Educational programs reviewed, aligned,
  publicized MPH in Clinical Investigations
• Inauguration of Data Safety and Monitoring
  Committee
• Development of Rapid Response IRB
• Fall 2006
• Data Management Core added to UKCRO/GCRC
• December 2006
• Web site for Clinical research developed
• January 2007
• Biostatistical core added to UKCRO/GCRC

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This is an exciting time for clinical,
translational and basic science research and for
the University of Kentucky. If we succeed in
our preparation to be successful for a CTSA this
will surely help us attain top 20 status.If
we fail, there is the potential that we will be
left behind in the race for research success.We
must not fail.