The University of California, Davis (UCD) Cancer Clinical Trials Program represents a multidisciplinary team integrating the clinical and research expertise of physicians, pharmacologists, molecular biologists, biostatisticians, research nurses and clinical research coordinators for the NCI-designated UCD Cancer Center and its outreach network facilities, the Northern California VA Health Care System, and an extensive community affiliate program. As documented in this proposal, during the last grant cycle UCD continued to have a strong presence in both the science and patient accrual objectives of SWOG. During the grant cycle (January 2004 - December 2008), UCD and its affiliates led SWOG with 342 new patient registrations. Scientific input in SWOG is demonstrated by strong contributions to study design and coordination, as well as by positions of Group leadership and provision of special expertise and resources. Pilot studies at UCD and preclinical data generated by UCD investigators continue to be translated into SWOG trials. Even greater scientific input is anticipated during the next grant cycle due to key recruitments and continued growth of the UCD Cancer Center. The overall objective of this proposal is to improve cancer outcomes by providing protocol-governed interventions to the North-Central California population.
Specific aims are as follows: Provide a scientific resource to SWOG in correlative science, thereby facilitating translation of laboratory discoveries into hypothesis-driven clinical research. Provide clinical trials sophistication in the design and conduct of SWOG studies, emphasizing institutional strengths in Urologic Oncology and Lung Cancer. Improve access to NCI-sponsored clinical trials, including cancer control and prevention studies, to the community at large, emphasizing underserved rural and minority patient populations in our area. These goals will be addressed by a multidisciplinary team of investigators with considerable experience and expertise in the conduct of cancer clinical research, an already proven track record in SWOG, and the dedicated resources of UCD's NCI-designated Cancer Center. Thus, UCD is particularly well positioned to take full advaritage of new opportunities for facilitating and coordinating SWOG-related clinical research studies in North-Central California.
Relevance of this UCD SWOG application to public health is demonstrated by the overall mission: to improve cancer outcomes, including cancer control, prevention and treatment, to the North-Central California population. Additionally, this proposal is designed to improve access to NCI-sponsored clinical trials to underserved rural and minority patient populations in our area. PRINCIPAL INVESTIGATOR: Dr. Gandara is a Professor of Medicine and the Associate Director of Clinical Research at the UCD Cancer Center, a position that he has held since 1993. He has been the SWOG institutional PI since 1996 and Chair of the SWOG Lung Committee since 1997. He is also the PI for the California Cancer Consortium Phase 2 award as well as the Phase 1 award. He is well-qualified to serve as the PI for this application. PROTECTION OF HUMAN SUBJECTS (Resume): ACCEPTABLE No concerns are evident. INCLUSION OF WOMEN PLAN (Resume): ACCEPTABLE No concerns are evident. INCLUSION OF MINORITIES PLAN (Resume): ACCEPTABLE No concerns are evident. INCLUSION OF CHILDREN PLAN (Resume): ACCEPTABLE Enrolled subjects are generally 18 years of age or older. OVERALL RECOMMENDATION: This application is rated 28 and is recommended for six years of support.
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