Clinical Protocol and Data Management

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ABSTRACT A critical component of the mission of the University of Chicago Medicine Comprehensive Cancer Center (UCCCC) is to offer patients the best and most personalized treatments available. The overall goal of the Clinical Protocol and Data Management (CDPM) is to establish and maintain the resources and processes to centralize and integrate the multidisciplinary component, and multidepartmental activities required to run and oversee a broad portfolio of clinical trials, including national cooperative group trials, other NCI/CTEP- sponsored trials and investigator-initiated trials developed through members’ translational research. An overarching theme is to ensure adequate enrollment of women, minorities, and children on our studies. The backbone of these operations is the Cancer Clinical Trials Office (CCTO), which is responsible for a) regulatory management for all adult cancer clinical trials, b) protocol tracking and management through a centralized Clinical Trials Management System (Velos eResearch); c) affiliate institution coordination and oversight, including 7 National Clinical Trials Network (NCTN) and Personalized Cancer Care Consortium affiliate networks, as well as over 40 additional ad hoc institutions; and d) quality control through centralized education and training, and formalized data and safety monitoring. We have well-established guidelines and a training manual for orientation of new regulatory managers as well as a centralized website with training videos, reference materials and Standard Operating Procedures (SOPs). The Office interacts closely with the UCCCC Information Technology Group, the Protocol Review and Monitoring System and the IRB. In 2016, the CCTO opened 152 new protocols (24% were investigator-initiated); a total of 914 patients were enrolled on therapeutic trials with 19% being minority (13% African American) and 48% women; 3286 patients were on non-interventional trials, with 49% minority (46% African American) and 56% women. Over the current grant cycle, we have streamlined and strengthened our audit program and instituted a number of efforts to increase accrual to trials including: e-newsblast to referring physicians, reformatting public-facing clinical trials listing on the UCCCC website, and development of new education and training materials, as well as building clinical trials infrastructure in our growing off-site network affiliates. Over the next five years, we plan to continue on this trajectory of improved and more efficient service, as well as to develop new services as needed. Major University of Chicago Medicine strategic initiatives, such as the additions to our integrated to network, as well as our network of off-site locations will necessitate continued expansion and refinement of our clinical research infrastructure including: a) Expansion of clinical trial access and functionality at network sites; b) Continued development and implementation of strategies to increase patient accrual; and c) Building on existing integration with Departmental research staff (e.g., data managers and nurses) through training and joint SOPs.