CTWG Update for caBIG Strategic Planning Workspace

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CTWG Update for caBIG Strategic Planning
Workspace
Monday, September 11, 2006

• Meg Gronvall, Senior Associate
• Booz Allen Hamilton,
• CTMS Workspace Lead

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Agenda

• The CTWG Report Background and History
• Introducing the new CTWG Informatics-based
  Initiatives
• Progress Update

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Clinical Trials Working Group (CTWG)
ReportRestructuring the National Cancer Clinical
Trials Enterprise

• CTWG Vision Statement
• Enhance the best of all the components of the
  NCI-supported clinical trials system to develop a
  cooperative enterprise built on a strong
  scientific infrastructure and a broadly engaged
  coalition of critical stakeholders.

CTWG Report http//integratedtrials.nci.nih.gov/i
ct/CTWG_report_June2005.pdf
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Clinical Trials Working Group (CTWG) Report
Summary

• The initiatives resulting from the CTWG report
  are designed to support a powerful and
  transparent clinical trials enterprise that
  integrates the individually strong components of
  the current system into a cross-disciplinary,
  scientifically-driven, cooperative research
  effort.
• The result of this broad-based,
  strategically-driven effort, involving all the
  critical stakeholders in the cancer clinical
  trials community, is the compendium of 22
  initiatives detailed in the CTWG Report.

CTWG Report http//integratedtrials.nci.nih.gov/i
ct/CTWG_report_June2005.pdf
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Four related informatics-based initiatives

• Establish a Comprehensive Community-Accessible
  NCI Clinical Trial Database
• Promote Information Sharing Exchange
  between Systems Supporting NCI Clinical
  Trials
• Establish a Core Library of Standardized
  Case Report Forms (CRFs) through
  Stakeholder Consensus
• Develop a Credentialing System for Investigators
  and Sites

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Establish a Comprehensive, Community- Accessible
NCI Clinical Trials Database

• Establish Cancer Research Community involvement
  in Clinical Trials Database definition,
  development and adoption activities
• Define community needs for secure and transparent
  access to NCI clinical trial data and information
• To establish a single source for NCI clinical
  trial data
• To provide transparency on the status of clinical
  trials
• To support expansion of the database to include
  data from other public- and private-sector
  sponsors
• To enhance ability to compare and analyze data
  across trials with structured, electronic data
  information
• Define and execute NCI Clinical Trials Database
  implementation plan leveraging caBIG design
  principles and implementation standards

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Promote Information Sharing Exchange between
Systems Supporting NCI Clinical Trials

• Establish on-going Cancer Research Community
  involvement in opportunities to promote
  information sharing and exchange
• Define Cancer Research Community information
  sharing and exchange needs
• Align NCI internal and external IT systems to
  share and exchange research data, information and
  knowledge
• To enable secure and transparent NCI community
  access to clinical trials research data
• Develop a portal to support Clinical Trial
  Research activities including tools and services
  to support protocol initiation activities

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Establish a Core Library of Standard CRFs
Developed through Stakeholder Consensus

• Establish on-going Cancer Research Community
  involvement in CRF Standardization activities
• Define Cancer Research Community data capture
  needs
• Establish a core library of standardized CRFs
  developed through stakeholder consensus
• To reduce time, cost and effort of initiating
  executing clinical research trials
• To facilitate the regulatory review process
• To enable standardized data capture to enhance
  investigator ability to compare and analyze data
  across trials
• To eliminate the capture of clinically
  insignificant data elements

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Develop a Credentialing System for Investigators
and Sites

• Establish on-going Cancer Research Community
  involvement in credentialing system definition,
  development adoption activities
• Define Cancer Research Community investigator and
  site credentialing system needs
• To speed and simplify the trial initiation
  process
• To facilitate communication of changes in the
  status of individual investigators and sites to
  sponsors.
• To help keep the investigative community abreast
  of new trends in clinical trials, including
  legal, safety, and regulatory changes
• Explore existing credentialing systems
• Implement Investigator and Site Credentialing
  System

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Unified Process Framework
CTWG Report http//integratedtrials.nci.nih.gov/i
ct/CTWG_report_June2005.pdf
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Risk, Relevance, Quality
CTWG Report http//integratedtrials.nci.nih.gov/i
ct/CTWG_report_June2005.pdf
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Clinical Trials Database (CTDB)

• Launched the Clinical Trial Database SIG on June
  7, 2006
• Holding Monthly SIG calls
• Established an NCICB/CCCT/BAH Project Management
  Team to
• Draft Vision and Scope Document
• Develop Initial Structured Risk Matrix
• Develop a high-level project plan
• Define a multi-dimensional team

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Systems Interoperability and Harmonization (SIH)

• Launched the SIH SIG on June 8, 2006
• Holding Monthly SIG calls
• Established an NCICB/CCCT/BAH Project Management
  Team to
• Draft Vision and Scope Document
• Develop Initial Structured Risk Matrix
• Develop a high-level project plan
• Define a multi-dimensional team
• Conduct Clinical Trial Business Modeling
• Develop Systems Inventory

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Harmonized Library of Case Report Forms (CRF)

• Launched the CRF SIG on June 12, 2006
• Holding Monthly SIG calls
• Established an NCICB/CCCT/BAH Project Management
  Team to
• Draft Vision and Scope Document
• Develop Initial Structured Risk Matrix
• Develop a high-level project plan
• Define a multi-dimensional team
• Initiate analysis of CRFs

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Investigator and Site Credentialing

• TBD (in process of establishing the Project
  Management Team)

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Community Participation in the caBIG Clinical
Trials Management Systems (CTMS) Workspace (WS)
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Q A