The Clinical Research Office (CRO) of the Robert H. Lurie Comprehensive Cancer Center participates at all levels in the activation and conduct of clinical cancer research conducted through all of the affiliate network institutions. This includes limited assistance with protocol development, scientific and procedural review of new protocols, filing of initial submission and continuing reviews to the institutional review board, clinical research coordination, and data collection and management, assuring quality with outside sponsors or internal reviewers, coordinating procurement of biologic specimens for clinical/ laboratory correlates, and coordinating supervision of appropriate trials by statisticians and the Data Monitoring Committee. In the current reporting period (8/1/05 - 7/31/06) 50 investigators have utilized this facility, including 45 with external funding. These investigators came from 12 departments within Northwestern University;39 of these investigators are Cancer Center members. Since 2001, the number of studies open to accrual during each 1-year period ranged from 386 to 449 (389 in the current period). During this time the number of studies, of all types, that were active and requiring follow-up information ranged from 862 to 1040 (999 in the most recent period). A total of 4804 subjects were accrued to clinical trials at Cancer Center institutions from 8/05-7/06, including 3996 subjects (83%) enrolled at the main institution and 808 (17%) at network institutions. An additional 927 subjects were enrolled at other affiliated sites (ECOG affiliates, sites participating in local investigator-initiated trials). At Cancer Center network sites, there were 666 subjects enrolled to therapeutic protocols, 789 to studies involving other interventions, 1025 to epidemiologic or other observational studies, and 2324 to companion, ancillary or correlative studies. Importantly, 4332 of the 4804 (90%) total subjects, and 382 of the 666 subjects on therapeutic trials (57%), were enrolled on institutional trials with internal or external funding. During this grant cycle, five initiatives were undertaken: 1) continued development and enhancement of our Internet-based paperless protocol management system and clinical trial management system (Northwestern Oncology Trial Information System-NOTIS). Most recently this initiative has included upgrading the system to allow for roll-out of the database to our Cancer Center affiliates;2) development of a training program and training manual for clinical staff;3) development and implementation of a NCI approved Data and Safety Monitoring Plan;4) significant review and restructuring of the financial structure of the office, resulting in enhanced financial reporting;and 5) a comprehensive review of the CRO's protocol initiation process, resulting in recommendations that have decreased initial protocol approval times from 32 weeks from July-December 2004, to 19 weeks currently. Future developments for the CRO will include expansion of the NOTIS to include electronic data capture (from main institution electronic charting resources) for local investigator-initiated trials, and further enhancements to CRO financial tracking mechanisms that will allow the office to more efficiently and accurately manage all financial aspects of trials (billing, CRO recharges, financial projecting, etc...).
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