PROJECT SUMIVIARY (See instructions): Shared Resource Core B. Clinical Support. James Vredenburgh, M.D., Core Director The Clinical Support Core provides a centralized resource to promote scientific and clinical research advances via interdisciplinary communication and collaboration across four key infrastructural components including biostatistics, informatics, neuropathology and immunomonltoring. Effective interaction within and across these four resource components will enable the successful clinical translation and implementation of novel therapeutic approaches against malignant brain tumors developed in Projects 1, 2 and 3 of this grant. Facilities and Equipment available among the four resource components of this Core are extensive and provide ample support to complete the studies and objectives outlined in this application. Similarly, methods and services available for this Core reflect the culmination of years of extensive research experience and acquired capabilities led by senior scientists and physician-scientists with a lengthy and productive history of interactive collaborations amongst each other as well as with the leaders of Projects 1, 2 and 3. The most compelling rationale for integrating the four key resource components of the Clinical Support Core into a centralized resource rather than including them separately for each project in this application is to optimize nterdisciplinary communication and effective interaction specifically regarding these critical support areas across the projects of this grant.
Our Specific Aims are: 1. To provide coordinated and systematic oversight and analysis during the design and conduct of the pre clinical and clinical studies outlined in this application in order to: a. Minimize toxicity and exposure of animals and humans to reagents being developed and tested in Projects 1, 2 and 3, and to maximize the usefulness of data obtained in this context; b. Integrate data generated during preclinical development with that from specimens analyzed during clinical trials outlined in Projects 1, 2 and 3 within the Nautilus and Oracle Clinical databases. 2. To provide integrated pathologic, histologic, immunohistochemical and molecular diagnostic studies for Projects 1, 2 and 3 which will be entered into the Biorepository Nautilus database and linked to the Oracle clinical database for each patient; 3. To provide comprehensive immunologic monitoring of patients enrolled in clinical trials in Projects 2 and 3 using highly standardized/validated state-of-the-art flow cytometry-based assays.
The Clinical Support Core will focus on seamlessly and efficiently integrating four key infrastructural resource components across the projects of this proposal, that include biostatistics, informatics, neuropathology and immunomonltoring. Effective interaction within and across these four resource components will enable the successful clinical translation, implementation and evaluation of novel therapeutic approaches against malignant brain tumors developed in Projects 1, 2 and 3 of this grant.
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