A Lead Academic Participating Site in Oklahoma for the Design and Conduct of NCTN Clinical Trials

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Abstract The Stephenson Cancer Center (SCC) at the University of Oklahoma Health Sciences Center (OUHSC) plays a crucial role in providing Oklahomans with access to National Clinical Trials Network (NCTN) and other clinical trials, thereby helping to raise the standard of care in the State and region. At the national level, the SCC has provided significant leadership in the design and conduct of NCTN clinical trials. In 2014, the SCC was designated a Lead Academic Participating Site (LAPS) in the NCTN. Since that time, it has worked to advance the following Specific Aims: (1) providing scientific leadership and coordination with NCTN components to design and conduct NCTN clinical trials for newly developed therapies, including multi-modality treatments, combinations of novel agents, molecularly based treatments, Precision Medicine screening, and advanced imaging approaches; (2) effectively integrating scientific expertise and clinical trials management capabilities at the SCC in order to activate, conduct and complete NCTN clinical trials in an efficient, timely and compliant manner; and (3) accomplishing Aims 1 and 2 within the context of providing high-quality cancer care and access to NCTN clinical trials for all Oklahomans, with a special emphasis on the State's underserved populations which experience disproportionately high rates of cancer health disparities. To advance Aim 3, the SCC utilizes patient navigators, social workers and targeted educational information to address barriers to enrolling patients on NCTN and other clinical trials. Specifically, the SCC has implemented an innovative American Indian (AI) Patient Navigation program to serve the Oklahoma's large AI population and promote enrollment to NCTN and other clinical trials for this population under-represented in clinical research. Clinical research activities at the SCC are overseen by a well-defined governance structure and supported by a centralized Clinical Trials Office (CTO) that manages regulatory, data management, study coordination, informatics, quality assurance, and biospecimen acquisition for all cancer clinical trials. The CTO functions as a core resource and receives funding from a variety of sources in addition to clinical trial direct cost dollars, allowing it to be proactive in faculty and staff education and career development, and leading to enhanced expertise and support capabilities. The collective knowledge base and cross-training within the CTO allows for adequate staffing and knowledge at all levels of research activity and ensures a coordinated research team approach for clinical research. The SCC is a Main Voting Member for NRG Oncology and the Alliance for Clinical Trials in Oncology, and it is a Full Member of SWOG and ECOG-ACRIN Cancer Research Group. It has worked efficiently and expeditiously with the respective Network Group operations, data management, and statistical centers to accomplish the Specific Aims of the grant.