CTWG Informatics Initiatives
The CTWG recommended four initiatives to define, design, build, and deliver a comprehensive clinical trials informatics infrastructure 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.
- 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©) 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).
NCI Center for Bioinformatics (NCICB) provides the program management and infrastructure through caBIG© to implement these four CTWG informatics initiatives.