Monday, January 30, 2006

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Data Analysis Interface for Cancer Centers and
Stand Alone Submission Infrastructure

• Monday, January 30, 2006

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Project Scope

• Establish a centralized and independent
  infrastructure for data submission associated
  with clinical trials for all of NCI
• Electronic submission
• WEB based submission
• Transition CTEP to start using new NCICB
  established infrastructure
• Develop a mechanism to provide data access
  (analysis and reporting) to stakeholders
  including cancer centers, cooperative groups and
  single institutions

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Project Tasks

• Task I (CDS SL)
• Stand Alone Submission Infrastructure Reuse
  CDUS Smart Loader (SL)
• Task II (CDS Web)
• WEB based data entry (submission) mechanisms for
  single institutions (including transition for
  CTEP) Reuse CDUS-Web
• Task III (CDS AR)
• Data Analysis and Reporting Interface for Cancer
  Centers Reuse CDUS Reports
• Task IV
• Routing CDUS SL data entry point from CTEP to
  NCICB (includes data migration performance
  tuning) single submission mechanism
• Task V
• Mapping CDUS/CTMS data elements to Janus/SDTM
  Gap Analysis
• Task VI
• Analyze technology infrastructure using SDTM data
  standards (Out of Scope) Standardization
• Task VII
• Assess Feasibility of getting CTMS data sets
  using current technology (CDS- SL)
• Task VIII
• Conduct Gap Analysis for supporting Summary 3 and
  4 reports against current infrastructure

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Implementation Schedule

• Task I (CDS SL) June 2006
• Task II (CDS Web) March 2006
• Task III (CDS AR) April 2006
• Task IV June 2006
• Task V February 2006
• Task VI TBD
• Task VII March 2006
• Task VIII March 2006

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Task I Submission Infrastructure (CDS Smart
Loader)

• Develop an independent and stand alone data
  submission infrastructure (electronic) at NCICB
  to serve as the primary data resource for NCI
  sponsored clinical trials
• Submit data via secure FTP server
• Assess feasibility of data submission via secure
  web services (CDUS-CTMS SIG recommendation)

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Task I CDS SL

• Technology
• Reuse technology adapted by CTEP (CDUS-SL)
• Transfer the as is model from CTEP
• As is technology to be used
• Oracle database
• Oracle Reports
• Oracle PL/SQL
• Technology used to be caBIG compliant
• Java based interface to build supporting
  application Protocol Abstraction, Dose Regimen,
  Entity Definition and Relationships

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Task I CDS SL

• What data is submitted
• CDUS Abbreviated
• Protocol Administrative (i.e. status)
• Patient Demographics (i.e. race, ethnicity,
  gender, etc.)
• CDUS Complete
• Protocol Administrative
• Patient Demographics Administrative (i.e.
  patient on trial)
• Response, Toxicity, End Points, Publications
  Authors, General Data Summary
• All submitted data should be CUMULATIVE

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Task I CDS SL

• Smart Loader Approval, Disapproval, and
• Correction Process
• Data loads are either successful or unsuccessful
  (partial success is not an option)
• Data Elements have been grouped into the
  following three categories
• Mandatory
• Requested
• Optional

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Task I CDS SL
Smart Loader Approval, Disapproval, and
Correction Process Cont()

• Mandatory data elements
• These are defined by CTEP as the minimum
  information required for processing the data
  submission and to track patient enrollment on
  study
• Investigators must submit all mandatory data
  elements

• Requested Data elements
• These are defined by CTEP as the minimal
  information necessary to fulfill the regulatory,
  scientific and administrative needs of the NCI
• Investigators must provide all known requested
  data elements

• Optional Data Elements
• In general the optional fields are free text.
  These fields should be used by investigators to
  provide additional data that may not be readily
  apparent from other information submitted
• Submission of optional data is at the
  investigators discretion

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Task I CDS SL
Smart Loader Approval, Disapproval, and
Correction Process Cont()

• The Anticipated problems with the submitted data
  have been grouped into 4 categories
• Incomplete Data files that do not contain all
  mandatory and requested data elements will be
  considered incomplete
• Incorrect Data that are submitted in the wrong
  format or with invalid values
• In appropriate Data that do not meet
  electronically preset criteria (e.g. patient
  weight gt 120 kg or first date of treatment gt
  protocol activation date)
• Inconsistent Data elements that are not
  expected to change from one submission to the
  next (e.g. patients gender)

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Task I CDS SL
Smart Loader Approval, Disapproval, and
Correction Process Cont()
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Task I CDS SL

• Requirements
• Develop Java based interfaces (leverage
  caFRAMEWORK) for the following base modules to
  allow SmartLoader to function independently
• Protocol Abstraction Module for protocol
  related attributes and administrative information
  such as Lead Organizations, etc.
• Dose Regimen Module for treatment assignment
  related information
• Entity Definition and Relationship Module for
  setting up appropriate security privileges and
  other profile information
• Create stand-alone Oracle instance of appropriate
  table structures and reference data including
  reference data such as gender/race codes etc.,
  and MedDRA, CTCAE vocabularies at NCICB
• Setup independent FTP site for data submission to
  this new infrastructure (assess feasibility of
  web services based submission mechanism)
• Develop appropriate use cases and appropriate
  system/technical documentation
• Map all CDUS data elements to CDEs in caDSR

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Task I (CDS SL)
Process
Load Status/Error Log
Meta Data
Cancer Centers/Sites
Submission Database
Extract Data
FTP Server
SL
Security Layer
Supporting Applications
Data Files (Comma delimited)
Reference Data
Entity Relationship
Dose Regimen
Protocol Abstraction
Sponsor
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Task I (CDS SL)
Data Loading Process
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Task II Web Entry/Submission (CDS Web)

• Develop an independent and stand alone submission
  infrastructure at NCICB (web entry) to serve as
  the primary data resource for NCI sponsored
  clinical trials
• Enter/Submit data via a web based interface

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Task II Web Entry/Submission (CDS Web)

• Requirements
• Implement a web based infrastructure to submit
  clinical data
• Develop appropriate use cases and appropriate
  system/technical documentation

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Task II Web Entry/Submission (CDS Web)
Process
Load Status/Error Log
Cancer Center
Meta Data
Submit Data
CTEP
Analysis and Submission Database
Submission Database
Data Bridge
Supporting Applications
Reference Data
Entity Relationship
Dose Regimen
Protocol Abstraction
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Task II Web Entry/Submission (CDS Web)
Technical Architecture
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Task III Data Analysis Interface (CDS AR)

• Data Analysis Interface for Cancer Centers to
  retrieve the clinical data submitted via CDUS
• The data analysis interface enables the users to
  view and generate reports about various aspects
  of the clinical trial process.
• The scope of this task is limited to existing
  data reports that are available internally to
  CTEP staff

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Task III Data Analysis Interface (CDS AR)

• Technology
• Reuse technology adapted by CTEP
• Transfer the as is model from CTEP
• As is technology to be used
• Oracle database
• Oracle Reports
• Technology used to be caBIG compliant
• Java based interface to query data

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Task III Data Analysis Interface (CDS AR)

• Requirements
• Redesign and develop new Java based
  interface/query screens for providing access to
  CDU-Reports
• Build additional security layer as appropriate
  for authorization and authentication and limiting
  access based on protocols and/or institution
• Develop appropriate use cases and appropriate
  system and user documentation
• The data and infrastructure for this effort will
  be hosted at NCICB
• Develop necessary interfaces to ESYS for
  refreshing data into the NCICB repository
  (interim need)

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Task III Data Analysis Interface (CDS AR)

• List of Reports
• Accrual Reports
• Accrual by protocol
• Accrual by Gender/Race
• Accrual by Institution
• Estimated Vs. Actual accrual
• Document milestones
• Adverse Event Reports
• Adverse Event
• Patient specific AE
• Subgroup Adverse Event
• Subgroup Response and Adverse Event

• Correlative Study Findings Report
• Demographic Reports
• Patient Demographic
• Population Demographic
• Patient Dropout Report
• Publication Report
• Response Reports
• Response Information
• Response and Adverse Event
• Subgroup Response and Adverse Event

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Task III Data Analysis Interface (CDS AR)
Process
Query Builder
Query Data
Cancer Center
Java Interface
Submission Database
Analysis Database
Security Layer
Sponsor
Supporting Applications
Reference Data
Entity Relationship
Dose Regimen
Protocol Abstraction
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Task III Data Analysis Interface
Technical Architecture
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Task IV

• Routing CDUS data entry point from CTEP to NCICB
• Provides the sites with a centralized parser to
  verify the data prior to submission
• Perform 3-6 months of setup/testing in parallel
  with CDUS SL at CTEP
• Develop and test routines to update data to and
  from CTEP-ESYS
• Setup/testing involved for migrating FTP sites
  and file server for storing submitted data
• Training and communication for sites, CDUS
  operations team
• Identify, test and resolve issues associated with
  use of infrastructure to support multiple
  sponsors
• Synchronize changes/bug fixes and enhancements
  done locally by CTEP
• Performance tuning
• Harmonization between sponsors on new business
  rules
• Maintenance of software on updating new business
  rules

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Task IV
Query Data
Process
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Task V

• Mapping CDUS and CTMS data elements to Janus/SDTM

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Task VI (Out of Scope)

• Analyze technology infrastructure using SDTM data
  standards
• Design and Development of standards based SDTM
  submission infrastructure

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Out of Scope

• Task VI
• Accepting data using web services will explore
  feasibility
• Access to data via APIs
• Error logs in computable format

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Limitations

• One CDUS operations team
• Cannot have sponsor specific business rules
• 2 types of submission Abbreviated and Complete
  (No customization)
• Performance
• Plug and play dictionaries not allowed
• Customized LOV for individual site/protocol not
  possible

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Risks

• Potential security issues
• Current CDUS infrastructure has limitations that
  will soon need to overcome requiring a redesign
  based on SDTM (Task VI)
• Ongoing change management and maintenance plan
  will need to be defined as multiple sponsors
  start using the infrastructure

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Questions