caBIG Kickoff Clinical Trial Management Adopter CapabilitiesInterests

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caBIG Kick-offClinical Trial Management Adopter
Capabilities/Interests
Chao Family Comprehensive Cancer
Center University of California, Irvine

• Frank L. Meyskens, Jr., MD
• Director, Cancer Center
• Christine McLaren, Ph.D.
• Director, Biostatistics Core
• Yi-Cheng (Andrea) Hwang, MS, MBA
• Programmer Analyst
• February 20, 2004

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Current Status

• Clinical trial data is
• manually entered from paper records
• stored in various home-grown databases from
  various vendors (FileMaker Pro, Microsoft Access
  97)
• In collaboration with NCICB, we are in the
  evaluation and planning stage of a migrating
  project. Data will be entered into an Oracle
  Clinical environment hosted at the NCI.

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Data We Can Provide

• Data collected for the Chemoprevention Consortium
  (from medical records)
• Open trials in colon, prostate, oral, cervix
• Pending trials in melanoma
• Data collected from hypothesis driven
  investigator initiated (HDII) trials
• Treatment
• Diagnostic/screening
• Data Safety Monitoring Board (DSMB) reports
• Adverse event reports w/ narrative
• Protocol tracking data
• Patient registration databases
• Specimen tracking data and lab endpoints
• Additional basic science data

4
Tools We Need

• For data to be hosted at NCI, we will need
  front-end tools for
• Data entry
• Data extraction
• Reporting
• Protocol status tracking

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Tools We Need (cont)

• We need enhanced tools for data entry
• Remote Data Capture mechanism
• Easy-to-use CRF template library
• Enhanced adverse event reporting module to
  standardize the formats, vocabularies, etc. of
  AE reports
• Distributed patient registration mechanism
• We need a data extraction mechanism
• Our Biostatistics Core will use SAS to analyze
  data extracted from Oracle Clinical
• We need more flexible, sophisticated
  analysis/reporting tools to
• Answer day-to-day clinical questions on demand,
  (e.g., what patient is on what trial?)
• Generate patient-specific, patient-centered
  information on demand
• Indicate inconsistent data (i.e., highlight
  exceptions)
• Protocol tracking tool

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Capability to Evaluate the Tools

• To evaluate adopted tools, we have
• Data managers (15)
• Laboratory staff
• Programmer Analyst
• Biostatistics Core

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System Integration

• Our immediate need is to devise methods to
  migrate our production clinical data from various
  types of databases into a centralized Oracle
  Clinical environment.
• Once done, larger system integration will be
  possible.

8
Software Tools Validation

• Well consult with NCICB to learn from their
  C3D-S test plans and experiences.
• The data managers, lab staff and the programmer
  can validate
• User Interface
• Work flow
• Our Biostatistics Core can provide data
  validation for accuracy.

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Going Forward

• We will actively participate in the on-line user
  forum, meetings, etc.
• We are eager to exchange information, knowledge
  and experiences related to clinical data
  management with our peer workspace members.