Expanding Participation to Non-Group Members in Phase Iii Cooperative Group Treatment Trials

6533 Background: The NCI initiated the Cancer Trials Support Unit (CTSU) Independent Clinical Research Site (CICRS) Program at the ASCO Annual meeting in 2002. Building upon the CTSU's initial aim to expand participation of any NCI-sponsored Cooperative Group (Group) phase 3 trial to all Group and Community Clinical Oncology Program (CCOP) members, the CICRS initiative has enabled unaffiliated sites to enroll patients in a wide variety of Group trials. Methods: Interested oncology practices submitted applications that were reviewed by a committee, including external reviewers, to select the most qualified sites. They had to meet standards similar to those for Group members and were assessed for the quality of investigator credentials and site preparedness. Sites were required to demonstrate functioning IRBs, pharmacy facilities, and data management standard operating procedures to ensure a high level of clinical trials practice. A CTSU research nurse mentor was added to address challenges faced by the sites. Sites were required to enroll at least 5 patients per year to remain active participants. Results: Via the CTSU, a trial menu of over 60 Group phase 3 studies, and selected phase 2 trials, were made available to CICRS participants. Active CICRS sites are distributed over 19 states and 6 of the 7 highest accruers are in population areas with less than 300,000 persons. Participating sites were surveyed in January 2006 to better understand barriers to clinical trials enrollment and 68% percent reported the main barriers were dedicated staff, time, adequate IRB and financial support for research. Conclusions: Obstacles for participation in the CICRS program have been defined and strategies to overcome them are being implemented. Results of these efforts will be updated, including provision of survey results, updated accrual, audit results and a review of successful enrollment strategies. No significant financial relationships to disclose. [Table: see text]