NIH Roadmap BAA RM0423

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NIH Roadmap - BAA RM-04-23
Reengineering the Clinical Research Enterprise
Feasibility of Expanding Clinical Research
Networks
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NIH Roadmap wants to develop clinical research
networks that

• are based on common or inter-operable
  infrastructure elements
• conduct research both in academic and clinical
  care settings
• only existing networks should apply

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RM-04-23 Topics for Response (1)

• Common informatics standards interfaces
• More user-friendly informatics tools
• Informatics tools to merge patient care and
  clinical research data, while maintaining
  security and privacy
• Standard definitions of diseases and adverse
  events
• Use of standard minimal (core) data elements
• Clinical research networks of community-based and
  academically-based investigators

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RM-04-23 Topics for Response (2)

• Ways to involve minority investigators and
  participants in clinical research
• Expansion of inter-operable clinical research
  networks
• Methods to expand the versatility and medical
  area focus of existing networks
• Ways to incorporate different kinds of clinical
  research within a common network structure
• Sharing of data, images and specimens
• Training of research teams

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Offerors should discuss how they will address

• the HIPAA privacy rule
• human subjects protections including coordinated
  IRB review
• intellectual property rights and data sharing
  goals
• expanding existing networks

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Offerors must describe the

• clinical research networks that will participate
• informatics system underlying their network
• inter-operability with DHHS information standards
  (LIONC, SNOMED)
• extensibility and/or scalability of the
  informatics platform

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RM-04-23 Columbia Strengths

• Department of Biomedical Informatics
• School of Public Health
• Strong minority presence on the faculty and in
  the surrounding community
• Clinical Trials Network based in community
  medical practices

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RM-04-23 Columbia Aims (1)

• Establish a flexible information infrastructure
  for clinical research
• Develop a behavioral model of information
  technology use in clinical research
• Promote effective use of information technology
  through organizational and educational
  interventions

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RM-04-23 Columbia Aims (2)
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RM-04-23 Columbia Infrastructure Software

• Interface engine
• Data dictionary
• Database(s)

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Central Hub Infrastructure Software
CDISC Clinical Data Interchange Standards
Consortium
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Applications Software

• Electronic screening of patient registry
• Recruitment management
• Payment software
• Clinical trials metrics benchmarks
• Web-based GCP training

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Role of Community Researchersin Software
Development

• Specify software needs and services
• Field test early versions
• Incorporate software into workflow

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Factors That Promote Software Use
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National Clinical Research Network
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Expansion of Columbias CTN

• Increase the number of participating community
  medical practices
• Increase therapeutic groups (e.g., asthma)
• Initiate device trials in the New
  York-Presbyterian Healthcare System
• Increase pediatric trials (e.g., vaccine)

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The Next Step in NIH Network Development

• National
• Electronics
• Clinical
• Trials
• And
• Research Network

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RM-04-23 Benefits of Columbia Projects

• Make workflow more efficient, automated
• Manage recruitment better
• Improve data quality, participant safety
• Support creation of National Clinical Research
  Corps of community investigators
• Promote public-private cooperative ventures