CORE--CLINICAL INVESTIGATIONS

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Description: (Applicant's Description) The role of the Clinical Investigations Core (CIC) is to improve and increase clinical trials research at the University of Colorado Comprehensive Cancer Center. The Core Director is Scott Bearman, MD, and the Core Coordinator is Robin Hohsfield, RN, BSN. The Core performs a number of services to facilitate clinical trials research. These include scientific review, IRB submission, distribution of protocols to clinical sites and inclusion on the Cancer Center website; identifying and enrolling eligible patients; data collection and tissue/specimen procurement; adverse event reporting; coordination of patient treatment through the NCI Treatment Referrals Center mechanism; and maintenance of the CIC Database. In this grant period, we are requesting an increase in CIC support by 138% ($120,781($288,020). This budget increase is justified in several ways. There have been substantial increases in accrual to both therapeutic (43% increase) and cancer control (115% increase) trials since the previous competing renewal application. These increases are largely due to investigator-initiated studies. There is also a new service which the CIC provides, i.e. maintenance of a comprehensive relational database which was created entirely with institutional funds. The CIC Database supports SPORE studies and other funded projects. Furthermore, the CIC is a beta test site for the NCI?s Clinical Data Update System and is used to electronically submit data for Southwest Oncology Group and CaP CURE. In this funding period, the CIC will be creating protocol-specific front-end applications for funded studies, which will be supported, in part, through chargeback fees. New investigators, ongoing recruitments, and a dramatic increase in clinical space at Fitzsimons are expected to further increase accrual and usage of the CIC Database. Although the requested budget increase is large in terms of absolute dollars, it will only increase Cancer Center Support Grant support of the CIC budget from 3.6% to 6.9% in the first year. Moreover, due to the large increase in space, members involved in clinical trials research, our new Phase I trials program and planned recruitment, our strategic plan anticipates continued expansion of our clinical trials program.