The Clinical Research Office (CRO) o f t h e Robert H. Lurie Comprehensive Cancer Center (Lurie Cancer Center) of Northwestern University (NU) provides a centralized resource to facilitate the development, conduct and oversight of cancer-relevant clinical trials conducted at the Lurie Cancer Center. This includes assistance with protocol development, scientific review of protocols. Institutional Review Board submissions (initial and ongoing), clinical research coordination, data collection and management, quality assurance monitoring, 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 (8/1/11-7/31/12) the CRO has provided primary clinical coordination, data management and/or regulatory support for 53 investigators, with 51 of these having external funding. The investigators came from 8 departments within Northwestern University's Feinberg School of Medicine;45 of the investigators were Lurie Cancer Center members during the year. Since 2007, the number of studies open to accrual during each 1-year period ranged from 458 to 560 in the current reporting period;accrual ranged from 4424 to 6047 (5977 in the current reporting period). Of the 5977 subjects accrued in the current reporting period, 1848 were accrued to intervention studies, including 1456 subjects (79%) enrolled at the main institution and 392 (21%) at network institutions. Accrual was 149 subjects (8%) to national group trials, 1092 (59%) to externally peer reviewed trials, 439 (24%) to institutional trials, and 168 (9%) to industry trials. Considering non-intervention studies, 4129 subjects were accrued in total, with 98 subjects (2%) to national group trials, 1027 (25%) to externally peer reviewed trials, 3001 (73%) to institutional trials, and 3 to industry trials. During this grant cycle, six initiatives were undertaken: 1) continued development and enhancement of our clinical trial management system (Northwestern Oncology Trial Information System [NOTIS]), including NOTIS'electronic case report forms (eCRFs), designed for local investigator-initiated trials. Enhancements include expanded eCRFs and a Principal Investigator (PI) portal for PI review and sign-off of data;2) roll-out of NOTIS to Lurie Cancer Center members sites and ECOG-ACRIN affiliate sites;3) development of standard operating procedures for all CRO services;4) restructuring o f t h e CRO to include dedicated data management staff. The resulting coordinator/data management teams have been restructured to be disease focused;5) enhanced focus on protocol development, with the creation of a Protocol Development Coordinator who assists investigators in protocol writing, and also in activation and implementation of new studies;and 6) most recently, the additional o f a Clinical Research Recruitment Coordinator, whose focus is recruitment in general, but with a top priority being the recruitment of under-represented populations
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