Biomedical Informatics Duke Translational Medicine Institute

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Biomedical InformaticsDuke Translational
Medicine Institute

• Ricardo Pietrobon, MD, PhD, MBA
• Director, Biomedical Informatics for DTMI
• Steve Woody, CIO for DTMI
• Robert Annechiarico, IT Director for Duke
  Comprehensive Cancer Center
• Jamie Cuticchia, PhD
• Director of Bioinformatics, Duke Institute for
  Genome Sciences Policy and Duke Comprehensive
  Cancer Center

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Summary

• Duke Translational Medicine Institute
• Operational plan and unique aspects
• Steering committee Short-term goals
• Steering committee Long-term goals

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Duke Clinical Research Institute

• World's largest academic clinical research
  institute
• Studies in over 3,600 sites in 64 countries
• More than 570,000 subjects enrolled
• Over 5,000 peer-reviewed publications
• Over 200 faculty members
• More than 5,000 investigators worldwide

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Duke Translational Medicine Institute
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Duke Translational Medicine Institute Structure
DTMI Administration
Education Training
Biostatistics and Biomedical Informatics
Core Laboratories
Regulatory Affairs
Project Leaders and the Portal Office
DTRI
DCRI
DCCR
Duke as Site



DCRU
New Molecule
Pre-clinical Development
First in Human
Phase II/III
Application in the Community
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Research on Research Cycle
Network
Monitoring
Theory
Tools
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Operational Plan

• Data
• Regulatory
• Education
• Communication

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Data

• EHR/EDC
• Data standards and EHR (SNOMED, HL7)
• CRIS and data visualization (University of
  Indiana)
• CRIS and statistical ontology (University of
  Utah, Rockefeller)
• Selection of central EDC system
• Institutional survey
• Guidelines for regulatory and data standards
  compliance
• Data standards development, validation, and
  implementation
• Three levels templates, templates
  instructional material, full-compliance
• Workshops
• Continued development and validation CDISC,
  SNOMED, BIRN, caBIG, HL7
• International network of domain experts
  (Stanford, University of Milan, University of Sao
  Paulo, Bombay University)

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Data

• Clinical and -omics repositories
• Integration of phenotype and -omics data
• Easy access through business intelligence tool
• Streamlining of regulatory processes
  integration with eIRB and oversight by governance
  body
• Phase I/II Units Durham, Kannapolis, Singapore,
  Taiwan
• Databases for volunteers, scheduling, and data
  capture
• Validation of data interface for data capture
  tools

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Regulatory

• CTMS
• Single institutional system
• Guidelines for alternative systems
• Comparison among existing systems to identify
  weaknesses and opportunities (University of
  Pittsburgh)
• Project management system for studies other than
  trials
• Web 2.0 concept
• Control of source code for authentication and
  security
• Guidelines for alternative systems
• Multi-institutional subject and informed consent
  repository (University of Texas-Houston)

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Education

• Wikis and simulation environments
• Statistical analysis, scientific writing, project
  management, contract negotiation (Research
  Triangle Institute, University of Milan, Clinical
  Research Network in Brazil 18 universities)
• Research simulation groups and domain expert
  network (University of Milan, Clinical Research
  Network in Brazil 18 universities)
• Database of ongoing trials and forums for
  participatory research
• www.dukehealth.org

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Communication

• Virtual communication
• Online modules on use of VoIP, web-based project
  management systems, shared-screen technologies,
  web-based calendars, on-line writing systems
• Promotion of translational research
• Decision support tools for research champions
• Triad clinical researchers, basic researchers,
  funding (University of Indiana)
• Central publication and expertise repository

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Steering committee Short term

• Open communication channel (forums, blogs,
  conferences) to facilitate
• Joint purchases of hardware software and hardware
• Joint approach of companies for development
  support
• Joint grant submissions
• Source code
• Sharing of educational material
• Sharing of open source code

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Steering committee Long term

• Interoperability
• Data
• Meta-data
• Expertise
• Joint projects to evaluate research informatics
  and its ROI