The translation of basic research findings, which identify new drugs or novel targets of anti-neoplastic agents, into the clinical setting is given the highest priority at the HLMCC. Attaining the capability and expertise to perform early phase clinical trials driven by basic research results has recently been identified as a priority of the PRCC. The goal of the clinical research project within this planning grant is to establish an Early Phase Clinical Trials Program at the PRCC, which, in collaboration with the HLMCC, focuses on investigator-initiated Phase I and II clinical trials with significant correlative laboratory studies. This goal will be approached by the following specific aims.
In Specific Aim 1 we will assess the capabilities of the PRCC to initiate and conduct Phase I and II clinical trials that have pharmacokinetic, pharmacodynamic, and molecular endpoint analyses. Based on the results of Specific Aim 1, during Specific Aim 2 we will formulate a plan to establish an Early Phase Clinical Trials Program at the PRCC which will collaborate with the HLMCC Clinical Investigations Program on Investigator-initiated studies. Finally, in Specific Aim 3 we will initiate joint early phase clinical trials, which are driven by basic research findings from either the PRCC or HLMCC, that include biochemical and molecular analyses of patient tumor samples. Relationship of the Project to the Overall Objectives of the Collaboration The objectives of the HLMCC relative to this P20 planning grant are to improve its access to minority populations, to develop research interactions leading to new knowledge related to minority health concerns, and to train minority clinicians and scientists. The objectives of the PRCC are to strengthen cancer research in Puerto Rico while developing effective research interactions with Moffitt researchers, and to augment the training of Hispanic clinicians and scientists dedicated to cancer research and treatment. This clinical trials research project will contribute to achieving all of the objectives described above for both institutions, and will be especially important in fostering basic and clinical research interactions between investigators at the HLMCC and PRCC, as well as strengthening early phase clinical research efforts at the PRCC.
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