CLINICAL TRAILS CORE

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The mission of the Case CCC is to develop and support a highly collaborative and translational clinical trials program, which is fully integrated and bridges the Case CCC scientific partner institutions at UHC and CCF. The goal is to provide access for cancer patients residing in northeast Ohio to state-of-the-art clinical trials, to develop new anticancer therapies, and to contribute to the clinical science of advancing therapeutics for the cancer patient. The Clinical Trials Shared Resource, also referred to as the Clinical Trials Unit (CTU) core facility, is responsible for the registration of patients and/or participants and data acquisition for all cancer protocols, including externally peer reviewed, institutional, pharmaceutical sponsored, and cooperative group clinical trials at UHC and CCF. The CTU is part of the overall support for clinical trials research and is coordinated with the PRMS, the DSMP, and is aligned with the priorities of clinical research as outlined by program and senior leaders. The coordination functions of the CTU have been developed and redeployed to reflect the coordination of activities supporting clinical trials research at the partner institutions. These processes were approved after review by the Case CCC EAB. Under the partnership arrangement, two prominent and clinically active institutions, UHC and CCF, combine efforts in clinical trials cancer research. The responsibility of the CTU is to coordinate these activities, providing oversight for research staff training, quality assurance and audit review, developing policy and procedures for clinical trials activation, accrual and management, and having a procedure for management of disagreements and operational details. Since the CTU serves as the clinical trials research coordinating center, which is expected to expand to include oversight to other hospitals that are affiliated with Case (Metro Health and the Cleveland VA), or owned by the hospital systems of UHC or CCF (a total of 7 other affiliated institutions), the Case CCC needs to have strong centralized authority. To this end, the CTU is organized to include centralized functions within the Case CCC and distributed responsibilities that reside within the partnership hospitals, currently the Ireland Cancer Center of UHC and the Taussig Cancer Center of CCF. In 2005, a total of 3,249 patients were enrolled onto Case CCC clinical trials, including 877 therapeutic (31% of whom are registered to investigatorinitiated trials) and 2,366 non-therapeutic studies. PERFORMANCE SITE(S) (organization, city, state) University Hospitals of Clevel