A primary goal of the clinical trials efforts of UPCI is to design, implement and analyze innovative, investigator-initiated pilot and phase 1 clinical trials. The development, initiation, implementation and completion of UPCI investigational studies receive substantial and essential support from UPCI Clinical Research Services (CRS). In 2008, 349 of the 1158 total UPCI patients (30%) participating in interventional clinical trials were entered onto institutional studies initiated by UPCI investigators. These investigatorinitiated trials focus on translational research and involve investigators from all of the translational and disease-specific programs of UPCI. Protocol-Specific Research Support has been instrumental in enabling several of these trials. Review of trials supported in the last grant cycle shows that the many PSRS supported trials advanced to the point of support by other mechanisms and/or publication of results. Requests for PSRS support of novel pilot or innovative phase I clinical trials are made by the PI at the time of submission of the trial to the Protocol Review Committee (PRC). Trials are evaluated for innovation and novelty, as well as availability of other sources of support, at the time of PRC submission. Trials with potential to be supported by PSRS funds are forwarded to the Associate Director of Clinical Investigation who makes recommendations to the Director of UPCI for final approval. Funds are used to support the effort of expert research nurses, termed Clinical Research coordinators, who can assist investigators with all aspects of trial implementation and execution.
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