This application is being submitted by Loyola University Chicago, Stritch School of Medicine, Cardinal Bernardin Cancer Center for renewal of this institution's long-standing participation as a site for the conduct of clinical trials under the umbrella of the Southwest Oncology Group (SWOG). Loyola remains a highly productive member of SWOG, enrolling 674 subjects to SWOG studies over the past 5 year grant cycle. Twenty-one members of the Division of Hematology/Oncology faculty are members of SWOG. Loyola's Departments of Radiation Oncology, Surgery, Thoracic Surgery, Urology, Gynecology and Pathology are active participants in SWOG-sponsored studies, identifying patients for inclusion in SWOG studies and for the subsequent treatment of these patients. The Clinical Research Office of the Cancer Center consists of 11 Registered Nurses, 4 Protocol Coordinators and 1 Regulatory Data Coordinator, who coordinate approximately 150 total clinical trials for all of the above disciplines. Loyola has four affiliate institutions participation in SWOG studies: Good Samaritan Hospital in Downers Grove, Illinois;Central DuPage Hospital in Winfield, Illinois, Edward Hospital in Naperville, Illinois, and Quad Cities CGOP in Davenport, lowa. Plans are underway to increase our commitment to SWOG during the next grant cycle both by increasing accruals with additional planned affiliates and increasing our scientific participation.
The Southwest Oncology Group is one of the NCI's CTEP-supported cooperative groups which seek new and more effective therapies for cancer. PRINCIPAL INVESTIGATOR: Dr. Stiff is an experienced clinical researcher with a long-term commitment to SWOG programs. He is fully qualified for his role on this application. PROTECTION OF HUMAN SUBJECTS (Resume): ACCEPTABLE No concerns are evident. INCLUSION OF WOMEN PLAN (Resume): ACCEPTABLE Women account for 63% of all enrollments. No concerns are evident. INCLUSION OF MINORITIES PLAN (Resume): ACCEPTABLE Minority accrual could be improved. Hispanics represent 10% of accruals and African-Americans represent only 3% of accruals. They report a series of important efforts to increase accrual of minority populations including development of a position for a community outreach coordinator, the work of a physician liaison to the Hispanic community, the use of short form consents for non-English speakers, the use of patient navigators, the provision of low cost screening breast studies for the medically underserved, and offering studies to a broad geography across the Chicago area. Additional planning efforts to increase minority accrual are needed. INCLUSION OF CHILDREN PLAN (Resume): ACCEPTABLE Enrolled subjects are generally 18 years of age or older. OVERALL RECOMMENDATION: This application is rated 24 and is recommended for six years of support.
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