Administrative/Clinical/Biostatistics Core

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PROJECT SUMMARY (See instructions): Core A will fulfill three major functions. One function is the overall management of the POI, which will be the responsibility of the Pl (Steven Balk) and the co-investigator (Peter Nelson). They will insure that administrative and regulatory requirements are met, but their main focuses will be on enhancing communication and collaboration between the Projects and on optimizing the use of the resources provided by the P01. The second function of the Core is to assist the Projects in efforts to translate their findings into patients. In addition to Drs. Balk and Nelson, Core A includes three investigators with a major focus on the design and conduct of clinical trials in prostate cancer (Drs. Mary-Ellen Taplin, Bruce Montgomery, and Glenn Bubley). Through previous/ongoing clinical trials and tissue banking efforts at their respective institutions, these investigators have collected valuable tissue and serum samples from patients at varying stages of their disease and after varying therapies. In discussions with the Project Leaders, they will facilitate the identification and distribution of relevant coded clinical samples for analysis by the Projects, and will assist in interpreting the clinical significance of the results. Moreover, Drs. Taplin, Montgomery and Bubley will assist the Project Leaders in the design and conduct of preclinical studies that can form the foundation for subsequent phase I or phase 11 clinical trials. The third Core function is to provide statistical support for each of the Project Leaders in their experimental designs. Lillian Werner, in the Department of Biostatistics and Computational Biology at DFCI, who also directs the DF/HCC Prostate Cancer SPORE Biostatistics and Computational Biology Core, is dedicating 10% effort specifically to this P01. The specific aims are: Aim 1. Provide administrative support to insure that the goals of the project are achieved. Aim 2. Assist in translating the results from each Project into the clinic. Aim 3. Provide biostatistical support for each Project.