Because of the emphasis placed on investigator-initiated trials (IITs) by the NCI in evaluation of Cancer Center Support Grants, IITs are a high priority category of trials DCC. IIT development is supported in part by the Bench-to-Bedside (B2B) monthly forum, which brings together basic, translation and clinical investigators to provide input for concepts prior to the development of investigator-initiated trial (IIT) protocol. New IIT concepts presented at the B2B monthly forum receive feedback from B2B executive committee and other B2B members and can be recommended for funding from DCC.
The Office of Clinical Research (OCR) protocol development specialist works closely with investigators to develop the IIT protocol, following a DCC template. Trials requiring IND/IDE are supported by the OCR IND specialist, who facilitates the FDA submission of IND/IDE applications. Upon further development of an IIT protocol, it is submitted to the Clinical Cancer Research Committee (CCRC) for scientific review and can be submitted in parallel to the IRB for human subjects review.