Core C: Clinical Support/Biostatistics will provide the Program Project investigators with resources necessary for the performance of clinical studies, including Pilot/Phase I vaccination protocols. The objectives of the Core are: (a) to identify patients who are candidates for participation in clinical trials; (b) to implement therapeutic and monitoring procedures for patients on clinical protocols according to the protocol requirements; (c) to provide basic researchers participating in the Program Project with adequate clinical materials to fulfill the objectives of the Program and facilitate the development of vaccines against squamous cell carcinoma of the oral cavity; (d) to provide research design, data management, data analysis, and biostatistical consultative support to all program investigators: (e) to assist the program investigators in the development of nested clinical protocols based on new data generated in the initial phase of the Program; (f) to help investigators in the preparation of summaries, abstracts, presentations and manuscripts. The core will support clinical and research activities of the Program by utilizing expertise and resources existing in the Departments of Otolaryngology, University of Pittsburgh and the UPCI Division of Medical Oncology and the Biostatistics Facility.
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