CTWG Update for caBIG� Strategic Planning Workspace

National Cancer Institute CTWG Update for caBIG™ Strategic Planning Workspace Meg Gronvall, Senior Associate Booz Allen Hamilton, CTMS Workspace Lead Monday, September 11, 2006 National Cancer Institute 2 Agenda • The CTWG Report: Background and History • Introducing the new CTWG Informatics-based Initiatives • Progress Update National Cancer Institute 3 Clinical Trials Working Group (CTWG) Report Restructuring the National Cancer Clinical Trials Enterprise CTWG Vision Statement Enhance the best of all the components of the NCIsupported 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/ict/CTWG_report_June2005.pdf National Cancer Institute 4 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 crossdisciplinary, 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/ict/CTWG_report_June2005.pdf National Cancer Institute 5 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 National Cancer Institute 6 Establish a Comprehensive, CommunityAccessible 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 publicand 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 National Cancer Institute 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 7 National Cancer Institute 8 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 National Cancer Institute 9 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 National Cancer Institute 10 Unified Process Framework CTWG Report: http://integratedtrials.nci.nih.gov/ict/CTWG_report_June2005.pdf National Cancer Institute Risk, Relevance, Quality Focus on Risk, Relevance, and Quality Lifecycle I Inception Phase Multi-disciplinary Workflow Lifecycle II Transition Inception Phase Phase Elaboration Phase Construction Phase Structured Risk Management Structured Risk Management Project Plan Project Plan Vision Vision and and Scope Scope Refine Vision and Refine Vision and Scope Scope Multi-dimensional Team Multi-dimensional Team 11 CTWG Report: http://integratedtrials.nci.nih.gov/ict/CTWG_report_June2005.pdf National Cancer Institute 12 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 National Cancer Institute 13 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 National Cancer Institute 14 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 National Cancer Institute 15 Investigator and Site Credentialing – TBD (in process of establishing the Project Management Team) National Cancer Institute Community Participation in the caBIG™ Clinical Trials Management Systems (CTMS) Workspace (WS) CTMS WS CTMS WS Routine Data Exchange Study Calendar Financial Billing Structured Protocol Representation Adverse Event Reporting CTMS Steering Committee Laboratory Interfaces Credential -ing CRF Standardization Clinical Trials Database Best Practices Data Sharing & Exchange 16 17 National Cancer Institute Q&A