The mission of the Clinical Trials Office (CTO) Shared Resource is to provide a supportive environment for the successful conduct of clinical trials in order to facilitate and promote clinical research within the UCSD Cancer Center. One of the fundamental activities of a cancer center is the translation of novel scientific information into new treatments for patients with cancer. This cannot be accomplished without an efficiently functioning infrastructure to support the clinical investigator in this endeavor. CTO services are provided to all principal investigators within the Cancer Center as evidence of value added for membership. It provides centralized administrative and management support for all clinical trials at every stage of development from inception to completion. Services include: (1) Assistance with protocol preparation. We have developed a CTO Handbook that provides specific instructions for protocol preparation and which is also a complete guide to protocol management; (2) Assistance in protocol preparation for submission to the UCSD Protocol Review Monitoring Committee as well as the Institutional Review Board. We assist in the preparation of the IRB application and protocol consent form; (3) Assistance in the preparation of the protocol for submission to outside regulatory bodies (e.g. FDA) and/or pharmaceutical companies; (4) Assistance in budget preparation for submission to extramural funding entities; (5) Following activation of a protocol, we provide complete CRA and data management support; (6) Assist in the identification of potential patients of all protocols that we manage; (7) Wide dissemination of information of information regarding active protocols to internal and other physicians through the use of printed and electronic media. We have developed and published a """"""""Protocol Handbook) that is provided to all investigators. Additionally, we participate in the maintenance of the UCSD Cancer Center Web Site wherein information on all protocols is provided. As evidence of the importance of this infrastructure, much of it implemented since 1998, we have increased the number of UCSD sponsored clinical trials by 30%, and have increased our accrual to clinical trials to 230% of the previous levels. Continued efforts are underway to further increase both the number of active trials and accrual through recruitment of faculty with established track records in clinical trials.
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