C4 - Clinical Research

The UI/MC SPORE Clinical Research Core (CRC) has as its primary goal to be the direct translational link between research projects and clinical research emanating from these projects. The CRC coordinates the development of clinical trials, assists in patient accrual, manages and reports adverse events to appropriate agencies, and provides quality control on clinical trial data. The CRC also hosts the Molecular Epidemiology Resource. The CRC provides a critical link between clinical research and the specific projects and cores. The CRC is co-directed by Brian Link, M.D., at the HCCC and Thomas M. Habermann, M.D., at the MCCC. Other key members of the CRC are Protocol Development Coordinators (PDC), Clinical ResearchAssociates (CRA), and Research Assistants (RA) located at both sites. The PDC functions with the PI and IRB to develop and activate the clinical trial and consent form. The CRA and RA assists in recruiting patients to the trials, schedules protocol tests, and collaborates with the Biospecimens Core and the specific research projects to ensure that translational research samples from patients are obtained according to protocol guidelines. The CRA and RA arranges for data entry into the Biostatistics and Bioinformatics Core. During the previous funding period, the CRC was very active and developed 4 clinical trials that accrued 113 patients. In addition, the Molecular Epidemiology Resource accrued 1,331 eligible patients through December 31, 2005. The CRC has worked with the Pis to develop the 4 projects in this competitive renewal and is in the process of protocol development for clinical trials outlined in Projects 1, 2, and 4. In addition, the CRC will provide ongoing support for the Molecular Epidemiology Resource that is being used in Project 3 and a developmental project, and is expected to be an increasingly valuable resource as it matures. The CRC will continue to recruit patients to the 4 trials that remain active from the first funding period and follow patients already enrolled until protocol endpoints are met. The CRC is also responsible for the clinical trials monitoring plans, which have been fully developed at both sites. These monitoring plans assure that the appropriate expertise is available to review the patient protocols, obtain IRB approval, and provide periodic review of ongoing protocol review to maximize patient safety. In summary, the CRC has been an extremely valuable resource during the first funding period. It has functioned at a high level and will be a very important core in the next funding period to support the clinical trials research, translational research projects, and epidemiology projects.