Core D provides the platform and infrastructure in which CRC investigators at multiple institutions develop, implement, execute, monitor, and analyze CRC clinical and laboratory data from subjects treated on clinical trials and enrolled in the CRC Tissue Bank. Furthermore, the investigators of Core D will identify and develop clinical research strategies utilizing new agents and combinations, with the ultimate goal of curing CLL. A primary objective of Core D is to provide indispensable clinical input and focus for collection and management of clinical data for CRC Projects and Tissue Bank. A web-based CRC Integrated Information Management System(CIMS) was developed in collaboration with the CRC Biomedical Informatics (CBMI) Workgroup. This system was designed to collect and manage clinical and laboratory information for patients samples stored in the CRC Tissue Bank and for patients treated on CRC clinical trials. This system enables collection of clinical and laboratory information from each CRC site via the Internet in real-time. Current and proposed efforts will be to transition to automated methods of data collection. Clinical research-based objectives will utilize clinical and laboratory information to develop new prognostic models, treatments and treatment objectives for patients with CLL. Core D will assure accurate and complete data collection for the following purposes: reports;patient scheduling/calendaring;data exports that facilitate analyses and reporting;and patient data monitoring and auditing and assuring regulatory and sponsor compliance required by each CRC clinical trial. Since last funding, the CRC has complete 5 clinical studies which are published, in follow-up, or in manuscript preparation. The CRC currently has 4 active clinical trials as detailed in this Core D write-up. Finally, there are 14 clinical trials in development as described in this Core D write-up and in each Project description throughout the grant application. Because there are circulating tumor cells that can be easily and readily accessed and given the scientific quality of CRC Project investigators, the CRC is uniquely positioned to do detailed correlative studies for patients treated on clinical trial in order to address mechanism of action questions and hypotheses testing and confirmation.
The Clinical Core D is fundamental and essential to the translational research proposed in this Program Project. Clinical data associated with Tissue Bank samples and clinical-translational data from patients treated on clinical trials are fundamental and essential to conduct of this CRC Program Project. All Projects utilize patient samples from the Tissue Bank and all Projects propose translational studies related to ongoing or planning clinical trials.
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