The Clinical Research Core combines the ongoing Patient Registry activities with the new clinical trial activities in all four translational research projects in the proposed funding period.
The aims of the Clinical Research Core are to: 1) perform the necessary clinical trial management support activities; 2) centrally coordinate all activities with the infrastructure of the Cancer Center CRO to ensure smooth execution of the SPORE?s early-phase clinical trials; 3) perform all patient recruitment activities for the clinical trials in the SPORE projects; 4) maintain the ultra-rapid case recruitment and registry of pancreatic cancer patients; and 6) serve as a resource to future Developmental Research Program and Career Developmental Program research projects. The directors of this Core have extensive experience in studies of human subjects and recruitment of patients to research protocols, both for observational studies and clinical trials. Mayo Clinic diagnoses and/or treats an estimated 650 pancreatic cancer patients per year across its three campuses. To date, the pancreatic cancer SPORE?s Patient Registry activities have been very productive, with accrual of 5,395 consented subjects, using ultra-rapid case finding, a necessary method for this rapidly fatal cancer. There are 3,121 pancreatic adenocarcinoma cancer patients in the Registry. In addition, the Registry includes data on over 2,500 age, sex, race, and region-matched healthy controls. It will coordinate its activities very closely with the Biostatistics Core and the Tissue Core to ensure the highest quality annotated biospecimens and pancreatic cancer database for research. The close coordination and oversight of the most senior leaders of the SPORE will ensure that all clinical research activities are performed with the highest level of research integrity and adherence to all human subjects regulations.
The Clinical Research Core has the goal of providing support to SPORE investigators who will perform human studies, including use of biospecimens and data from an ongoing patient registry, and execution of early phase clinical trials. The Core will adhere to the highest standards of integrity and quality and ensure compliance with all regulations and policies that govern human research.
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