The PSRS supports high quality and innovative clinical and translational trials. Ideally these trials have the potential to result in further funding opportunities or definitive clinical trials. This is key for CTEP sponsored trials as well as Investigator Initiated research which meet the criteria below. Important utilization of this resource over the current grant period includes a number of CTEP sponsored trials and trials with the herbal product, PHY906, which lead to the current Program Project Grant (P01) further characterizing the metabolic behavior of the product and cytokine mediated activity in its role as a cytoprotective agent. Criteria for support of these clinical trials are as follows: ? Trial should be high priority, innovative, feasibility (pre Phase I, pilot) and Phase I institutional clinical interventions focusing on initial early phase testing of a candidate agent or device for diagnosis, prevention, detection, or treatment of cancer. Support is not meant for all early phase I trials, for later phase trials, or for studies that do not involve testing of an agent or device. ? Trials must be conceptualize/designed by YCC members. ? Trials must be of short duration (likely one year or less.) ? Trials receiving support from other peer reviewed research grants, cooperative agreements, and contracts are ineligible. Trials may receive partial support from industry assuming all other .criteria are met. ? Trials must be approved by YCC's PRMS. ? Funding is restricted to research nurses and data managers directly involved trial conduct The personnel supported by PSRS are supervised by Dr. Paul Eder, director of the Phase I team and early drug development. Deployment of PSRS resources is approved by a committee consisting of Drs. Eder, Sznol and Hochster. Increasing demand on such resources, given the extensive and high level recruitment in the coming grant period is expected.
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