The Protocol-Specific Research Support (PSRS) is an effort to expand the number of investigator-initiated clinical trials at KCI. Support must be available to conduct preliminary studies, most of which are not presently funded by the NCI or other agencies. The purpose of the PSRS is to provide an administrative support mechanism to provide data management, collection of patient data, and to support innovative clinical trials within the Cancer Center. The objective is to foster investigator-initiated trials, which bring new results from our basic science laboratories to the clinical and population studies arenas. The awarding of PSRS to an investigator is done at the recommendation of the Scientific Leadersip Council. Associate center directors, Program leaders, or heads of the Multidisciplinary Teams can nominate protocols for support. Proposals are evaluated for their scientific merit and importance in developing new avenues of research within the Cancer Center. Although all proposals are given serious consideration, studies that show the potential to develop new avenues of research and secure external funding are encouraged. There are many investigator-initiated translational studies within the Cancer Center. These include novel and molecular targeted therapies, and functioning imaging techniques. These trials seek to test new, targeted therapies both as single agents, and in combination with more established cytotoxic therapy. They often include measurements of treatment effect based on blood samples and tumor biopsies. New imaging approaches are integral to this work as they provide a noninvasive way to test these treatment approaches. For the future, we plan to support a mixture of Phase I, Phase II, and imaging/correlative trials. Funding support for 1.5 FTE data management to support the innovative trials is requested. Data management will include confirming patient eligibility prior to registration to the trial, abstracting and collating data from various sources ensuring that qualtiy control checks are being conducted.
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