CTWG IT Initiatives

A major challenge facing the restructuring of NCI's clinical trials enterprise, as recommended by the CTWG, is defining, designing, building, and delivering a comprehensive clinical trials database that will serve all of the critical stakeholders. Such a database must be accompanied by an interoperable infrastructure including application tools, standard vocabularies, and data sets that promote data integration, project and program management, resource sharing, and building of repositories for storing and securely accessing clinical trial information. In implementing the restructuring of NCI's clinical trials enterprise, the CTWG recommended four specific informatics initiatives:

• Establish a comprehensive database containing information on all NCI-funded clinical trials to facilitate better planning and management across clinical trial Venues (CTDB).
• Promote, in partnership with the extramural cancer research community, a national cancer clinical trials information technology infrastructure fully interoperable with NCI's cancer Bioinformatics Grid (caBIG^TM) to improve cost effectiveness and comparability of results across trials and sites (SIH).
• In consultation with industry and FDA, develop standard Case Report Forms  (CRF) incorporating Common Data Elements to improve information sharing among cancer researchers and optimize data requirements.
• Develop a credentialing repository system for investigators and sites recognized by NCI and industry to allow faster trial initiation and keep the investigative community abreast of legal, safety, and regulatory changes (ISC).

NCICB with its experience in leading the caBIG^TM will provide the program management and infrastructure to implement these four CTWG informatics initiatives.

caBIG systems interoperability and harmonization

FDA/industry concurrence on standard CRF library

Comprehensive clinical trials database