caBIG^® and the NCI Clinical Trials Working Group

The purpose of the Clinical Trials Working Group (CTWG) is to advise the National Cancer Advisory Board and its Subcommittee on Clinical Investigations on the development, conduct, infrastructure, and support necessary for the optimal coordination and future progress of the entire range of intramural and extramural clinical research trials supported by the National Cancer Institute (NCI). These trials include diagnosis, treatment, and prevention studies. For more information on CTWG, visit http://integratedtrials.nci.nih.gov/ict/.

The CTWG was tasked by the Director of the NCI to define the vision and plan for restructuring the National Cancer Clinical Trials Enterprise to support "the promise of molecular medicine for advancing oncologic clinical practice". The caBIG^® program is expanding to incorporate broader community involvement and four clinical trials informatics-based initiatives. These endeavors will be coordinated under the Clinical Trial Management Systems (CTMS) Workspace as four new Special Interest Groups (SIGs) and will include:

• Establishing a comprehensive community-accessible NCI clinical trial database
• Promoting information sharing between systems supporting NCI clinical trials
• Establishing a core library of standardized case report forms (CRFs) through stakeholder consensus
• Developing a credentialing system for investigators

Further information is available under the CTMS Workspace at https://caBIG.nci.nih.gov/workspaces/CTMS/.

Speeding and streamlining clinical trial management will be a key enabling factor in the advancement of molecular-based patient therapies.

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