Core D - CLINICAL TRIALS CORE FACILITY

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The Clinical Trials Core Facility of The M. D. Anderson Cancer Center SPORE in Multiple Myeloma will translate highly promising findings with potential application to the prevention, early detection, diagnosis, prognosis, and/or treatment of multiple myeloma from the laboratory to the clinic. Clinical trials coordinated by this Core will also promote the flow of information from the clinic back to the laboratory, with the goal of helping to inform and optimize the design of future clinical interventions. In order to accomplish these objectives, the Core will have the following specific aims: 1. To coordinate the development, submission, and regulatory approval of the SPORE clinical trials, in collaboration with the Administrative Core Facility (Core A) and the Biostatistics and Bioinformatics Core Facility (Core E); 2. To assist SPORE investigators in rapidly and efficiently accruing patients to translational clinical trials emerging from SPORE Projects; 3. To report adverse events to the Institutional Review Board and appropriate agencies, and assure compliance with all applicable regulatory guidelines, in collaboration with Core A; 4. To provide quality control of the SPORE clinical trial data; 5. To analyze clinical trials data from SPORE studies in collaboration with Core E; and 6. To facilitate and coordinate correlative specimen collection from patients enrolled on SPORE trials along with the Myeloma Tissue Core Facility (Core B). Taken together, therefore, this Core will provide the crucial link between the bench and the bedside that will allow this SPORE in Multiple Myeloma to meet its translational goals, and improve the outcomes of patients with multiple myeloma.