CTSA Principal Investigators Meeting

1
Aligning infrastructure with research questions
Susan B. Shurin, M.D. Deputy Director, National
Heart, Lung, and Blood Institute

• CTSA Principal Investigators Meeting
• January 16, 2008

2
Goals of CTSA program

• Encourage the development of new methods and
  approaches to clinical and translational research
  
• Improve training and mentoring to ensure that new
  investigators can navigate the increasingly
  complex research system
• Design new and improved clinical research
  informatics tools
• Assemble interdisciplinary teams that cover the
  complete spectrum of medical research
• Forge new partnerships with private and public
  health care organizations

3
Goals of Clinical Translational Research in
Categorical Institutes

• Answer the scientific question (s)
• Train the next generation of investigators
• Advance biologic understanding with ancillary and
  related studies
• Relevant existing mechanisms
• Centers Institute-specific, institution based
• Networks organized investigator communities,
  single disease categories, multiple studies

4
Resources needed for clinical translational
studies

• Identification of scientific leadership,
  investigators
• Clear identification of scientific question (s),
  population, endpoints, interventions
• Rigorous design and analysis
• Interdisciplinary teams
• Recruitment plans
• Publication plans

• Regulatory and administrative support
• Statistical support
• Data collection, forms, monitoring
• Auditing
• Identification of sites
• Training of investigators and clinical research
  associates

5
Overlapping missions
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Leveraging investments

• Institutes need
• Access to subjects
• Infrastructure to support administrative
  activities
• regulatory
• data management
• Training resources
• coordinators
• professionals
• Multiple centers

• CTSAS need
• Targeted scientific questions and studies
• Opportunities for interdisciplinary teams to
  collaborate
• Content-specific training
• Support for specific studies
• Community-based research

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Some suggestions

• Studies of rare diseases managed by primary care
  physicians
• Sickle cell disease
• Community-based research on common diseases
• Type II Diabetes, COPD, Asthma, Atrial
  fibrillation, Depression, Alcoholism
• Population-based studies looking at areas of
  interest to multiple institutes

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Ensuring that we add value

• Mechanisms for early discussions between CTSAs
  and categorical institutes two way
  communication
• Clarity as to role of each entity
• Can CTSA infrastructure enable categorical
  institutes to conduct studies more rapidly
  without having to build and dis-assemble
• Can CTSAs provide global education and
  bioinformatics to improve conduct of clinical
  research in the US

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Possibilities

• CTSA infrastructure could enable categorical
  institutes to conduct studies more rapidly
  without having to build and dis-assemble
• CTSAs could provide education and to improve
  conduct of clinical research in the US
• Central IRB for NIH-funded studies
• Informatics systems which talk to each other or a
  common system

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