ONCORE Consortium

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ONCORE Consortium Development Project (ONcology
COllaborative Research Environment)
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Outline

• The Oncore Consortium
• Oncore Technology
• Towards a Collaborative Network
• Interface with caBIG

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The Oncore Consortium

• Cancer Center Members
• University of Wisconsin Comprehensive Cancer
  Center
• University of Iowa Holden Comprehensive Cancer
  Center
• University of Minnesota Comprehensive Cancer
  Center
• Vanderbilt-Ingram Comprehensive Cancer Center
• Stanford Cancer Center
• Case Comprehensive Cancer Center
• Industrial Partner
• PercipEnz Technology Inc.

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Mission and Purpose

• Create and support an ONcology COllaborative
  Research Environment (Oncore)
• Organizational mission
• Leverage cancer research expertise of members
• Define and promote best practices
• Leverage member resources to pursue collaborative
  research
• Create a network of networks
• Similar to the caBIG concept of a grid
• Technological mission
• Continuous improvement of an integrated
  information technology infrastructure of widening
  scope
• Embody operational experience of members

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A Network of Networks

• Consortium members anchor networks of affiliates
• Wisconsin Oncology Network (WON)
• Vanderbilt-Ingram Cancer Center Affiliate Network
  (VICCAN)
• Consortium members participate in programmatic
  networks
• For example UWCCC Chemoprevention Network
• Wisconsin, Iowa, Vanderbilt, Emory and Rochester
• Consortium joins these networks into a
  collaborative context
• Promoted by common interests and association
• Enabled by consortium technology

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Consortium Technology Goals
Continuously develop and maintain information
technology for cancer centers that

• Supports basic, clinical, population and
  translational research
• Embodies best practices and addresses regulatory,
  security and privacy constraints
• Promotes collaborative, multidisciplinary
  research in a decentralized, distributed
  environment
• Enables operational integration within and among
  centers
• Enables sharing of results and other information
  at the national level

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Method

• Organization
• Cancer center driven collaborative organized to
  provide direction to a skilled and committed
  technology company by establishing shared
  analyses, requirements and priorities.
• Commitment and funding
• Centers provide domain expertise and validation
  effort
• Industrial partner provides technical expertise
  and integration
• Funding is from centers, NCI SBIR grants, and
  private investment
• Process of Generalization
• Generalize requirements, ideas, projects,
  problems, practices and technologies of value
  that exist in each cancer center to create
  technology that can be readily adopted by all
  participating centers
• Result
• A collaborative program of continuous improvement
  converging on best practices and a common core of
  integrated, supporting technology of widening
  scope

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Oncore Technology

• Highly secure, web-based, cancer specific, and
  customizable
• Fully integrated clinical data management and
  study administration system
• Developed in an on-going collaborative effort
  with comprehensive cancer centers
• Addresses the needs of cancer center and
  affiliate staff including investigators,
  administrators, data managers, data and safety
  monitors, study coordinators, committee
  coordinators, and reviewers

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Oncore Technology (cont)

• Stakeholder Focused (center administrator, data
  manager, data monitor, principal investigator,
  study coordinator, biostatistician, )
• Centralized/Decentralized Organizational Support
• Process Centric Instead of Forms Centric
• Configurable and Customizable
• Dynamic, Context Driven Access Control
• Platform-based Architecture

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General Capabilities

• Study Setup and Activation Study Specification
  templates simplify setting up, managing, and
  conducting studies
• Custom Case Report Forms Modify, extend, and
  create electronic forms
• Committee Coordination Track and manage
  scientific review, data and safety monitoring,
  biosafety, and IRB
• Data Collection CRA Console provides highly
  efficient yet easily mastered data entry
• Data and Safety Monitoring Sophisticated
  monitoring, e.g., cross study toxicity reports,
  safety-monitoring rules, and automated e-mail
  notifications

• Reporting An assortment of reports (incl.
  Summary 3 and 4) and options that maintain
  critical security and access control policies
• Sophisticated Security Dynamic, Context-driven
  Access Control ensures that users only have
  access to relevant data and required functions.
• Domain Repository The Domain Repository is an
  extensible set of standard reference codes and
  forms to promote standardization
• Public Access Controllable public web access to
  protocol information
• Application Configuration Processes,
  notifications, and nomenclature can be configured
  to suit each center

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Active Works in Progress

• Protocol Metadata Analysis and Standardization
• HL7 Standards
• Interaction with SPORES, Secure Tissue Data
  Integration with trial specific information
• Information System Integration for Research Labs
• IRB Information Exchange
• Quality of Life (QOL) Data Management
• Internal Audit Support
• Ad hoc Reporting
• Study Information Portals for
• Referring Physicians
• Pharmacy
• Pathology
• Randomization and Stratification
• Protocol Schedule Compliance
• Study Reimbursement

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Towards a Collaborative Network

• Develop data exchange standards and secure
  technology for cancer center operational data,
  e.g.,
• Study set up information (eCRFs, schedules,
  tests)
• Accrual and subject information
• AE/SAEs and stopping rules
• Protocol compliance
• Challenges
• Heterogeneous technologies at participating study
  sites
• Security and regulatory compliance (HIPAA)

Centers using Oncore technology
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Internet
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Interface with caBIG
NCI Reporting (CCSG, CDUS, etc.)
National and Co-op Group Data Repositories
(e.g., Oracle Clinical)
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Standards for Outcomes, Reporting and Results
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Centers using Oncore technology
Centers using other technologies
NCI Intra-mural
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Standards for Operational Information
Technology dependent adapters
Oncore adapter
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