The broad objective of this proposal is to develop the University of California, Irvine (UCI) as an institution strong and productive in the performance of cooperative group trials.
The specific aims i nclude: (1) establishment of a high quality, productive clinical oncology trials effort at the University of California, Irvine, (2) expansion of clinical oncology trials to Orange County (and environs) CGOPs and Satellite Affiliates that use the University of California, Irvine as its SWOG institutional base, (3) recruitment of fully eligible patients into SWOG cooperative group phase II and III trials, (4) recruitment of at least a proportionate number of Hispanic, Asian, and socioeconomically disadvantaged patients into clinical oncology trials, (5) continued ongoing quality assurance program for trials conducted both on-site and off-site. Participation in SWOG trials represents a carefully crafted program in clinical research at the UCI Clinical Cancer Center. The conduct of trials is coordinated through a Clinical Trials Coordinator and data management staff under the day-to-day direction of biostatistician. Recruitment strategies, procedures for eligibility, evaluation, and follow-up, IRB issues and method of procedures have been standardized. CGOPs have been established at three large community hospitals. Additionally, Satellite Affiliates have been established with clinical faculty in Orange County and Long Beach. We have created an active Patient Advocacy Committee and recruitment of minorities and socioeconomically deprived individuals into trials is an important function. The initial effort has been successful and we plan to recruit a minimum of 100 patients per year into SWOG clinical trials.
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