Protocol Specific Research

包括分子生物学、基因组学和蛋白质组学在内的许多科学方面的进步导致了

Advances in many aspects of science including molecular biology, genomics and proteomics have resulted in significant advances in defining the causes of and new treatments for cancer. Close collaborations are needed to take advances from the laboratory into the clinic. These collaborations and resources available to conduct translational clinical research have been very productive during the current funding period. Currently, the CCSG provides funding for 0.25 FTE research nurse and 0.5 FTE clinical research specialist (CRS). The IU Simon Cancer Center has allocated this money by a process described in detail below to support investigatorinitiated Phase I and pilot studies that are highly meritorious. The ID Simon Cancer Center also provided additional funds from other sources for the conduct of these trials. We anticipate growing numbers of patients accrued to future phase I and pilot studies because of the recruitment during the current funding period of translational clinical investigators (Chiorean, Farag, Hahn, and Matei) and planned expansion of our phase I program during the next funding period. From 2004 through mid-2007, the IUSCC supported 15 clinical trials by this mechanism. Total patient accrual is to date 132. On occasion, the Center used additional funds to support individual trials. For example, additional IUSCC funds have been used to support the laboratory correlative studies associated with a trial supported by the PSR mechanism; the PSR funding has been used to support nurses and clinical research specialists. The process has been updated during the current cycle with resulting increased number of faculty conducting investigator-initiated trials. PSR support has been prioritized to protocols that will generate preliminary data that has been (or will be) used to support R21 Quick Trials and other peer-reviewed funding applications. The process to seek funding for the conduct of pilot clinical trials was updated in 2006 and is available to all IUCC members via a continuous RFA found at http://cancer.iu.edu/research/fundinq/clin trial.php. The announcement details the fact that Protocol Specific Research funding covers the cost of a core group of research nurses and data managers (clinical research specialists) for the conduct of high priority, innovative, feasibility or proof-of-principle clinical trials. The requests for funding are to be used for early-phase testing of a candidate agent or device for the prevention or treatment of cancer. Applications are received and reviewed monthly by the Clinical Research Committee.