CORE--CLINICAL RESEARCH

Northwestern University, Evanston IL

Investigators

Linked publications & trials

Abstract

The Clinical Core of the SPORE Program will be responsible for facilitating translational research by SPORE Investigators. The Core serves as an identifiable link between basic science research and clinical trials. The specific aims of the Clinical Core are: 1) to provide collaborative scientific guidance with respect to design of clinical trials in prostate cancer, thereby ensuring that individual trials are built around scientifically rigorous endpoints. 2) to provide infrastructure to support clinical trials review, implementation and monitoring, as well as clinical sample acquisition, processing, and storage. 3) to foster ongoing and future translational research. 4) to provide technical support for SPORE projects which require unique laboratory support for translational endpoints. The Clinical Core consists of the Director, Raymond Bergan, M.D., a research technologist, and a research nurse. The Core director will be available to assist investigators interested in initiating a clinical study, focusing upon translational and clinical endpoints, as well as protocol development and IRB submission for human subjects approval. The Core nurse will assist with actual clinical trials to insure that the clinical protocol is properly followed, provide support and education to participating patients, assist in the administration of therapy and assure timely entry of clinical data. The Core technologist will assist with special tests needed for clinical trials. The Robert H. Lurie Comprehensive Cancer Center has a large free standing Clinical Research Office (CRO), with extensive clinical trials management capabilities, as well as a NCI approved Clinical Protocol Scientific Review and Monitoring Committee. Northwestern University has a National Institute of Health funded General Clinical Research Center (GCRC) located within the Northwestern Memorial Hospital for clinical trials. The proposed Clinical Core will be responsible for designing clinical trials for CRO to be implemented. The Core will also be responsible for extracting unusual observations from clinical trials and guide the basic scientists for further investigation. The Core will interact closely with the SPORE Biostatistics Core in maintaining the database and with the SPORE Tissue Bank Core for banking of specimen samples.