For translational research to be successful there must be a two-way flow of information, from the clinic to the laboratory and from laboratory to clinic. Clinical interaction with patients and health care providers is crucial to the success of the research studies proposed within the SPORE, and to the long-term success of a translational program of breast cancer research. The Clinical Core of the SPORE program provides this critical link by incorporating a highly-effective breast cancer clinical team into the overall structure of the SPORE. The Clinical Core will be responsible for facilitating translational research through the support of clinical trials and clinical research studies, as well as providing dinical education throughout the program. Additionally, the Clinical Core will serve to mentor and find clinical collaborators for laboratory investigators, with particular emphasis on those funded through the SPORE's Developmental Research Program. The Clinical Core will assist SPORE investigators interested in initiating a clinical study, including preparation, review, approval, and activation of clinical studies. Interactions with patients and health care providers will be initiated and facilitated by the Clinical Core. The Core research manager will supervise research staff who will assist with SPORE-related clinical trials to ensure that accrual is achieved, overseeing clinical trials recruitment efforts, screening for trial eligibility, and contacting potential patients regarding study participation. The Core will communicate with institutional and regional oncology providers to seek physician support for referral into SPORE projects. The Core will consent and follow-up patients appropriate for SPORE projects and provide clinical and outcome data as required by these studies. The Clinical Core staff will be responsible for assuring that the clinical protocol is safely and properly followed, including monitoring toxicities and reporting adverse events. They will provide support and education to participating patients, assist in the administration of therapy, and assure timely entry of clinical data. By design, the Clinical Core will work closely with the Specimen Acquisition and Pathology Core, which will procure and process specimens for SPORE projects after initial contact is made through the Clinical Core. The Clinical Core will interact closely with the Biostatistical Core in designing and analyzing studies, and will be in close interface with the FHCRC/UW Consortium's Clinical Trials Support Office that is responsible for management of all clinical trials.
The importance of clinical expertise to effectively carry out translational research objectives cannot be overstated. Laboratory discoveries can only be developed into clinical tools if clinical input is incorporated early into all aspects of research planning and implementation. This Core is well-positioned to take advantage of FHCRC/UW Consortium research, clinical strengths and institutional alliances to maximize exchange of ideas and facilitate translation, both to and from the clinic.
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