The IGNITE II CC: Engagement, Coordination, Demonstration, and Dissemination

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Abstract Achieving the necessary, robust and continually evolving evidence base for genomic medicine and its implementation in clinical practice requires overcoming many practical and logistical challenges. The Implementing GeNomics In pracTicE (IGNITE) Network has been and will continue to be strategic in identifying and disseminating solutions to these challenges. Specifically, we will continue to address the absence of supporting information technology infrastructure, lack of data standards and interoperability, and insufficient decision support. The effectiveness of IGNITE in achieving its objectives requires an experienced, and well- organized coordination center (CC) with strong existing ties to genomic medicine, that can recruit participants, create a vast resource of best practices for pragmatic clinical trials (PCTs), develop and deploy common measures and standards, identify solutions to challenges in implementation, develop a platform for data management and data analysis, and disseminate knowledge to the greater community. The proposed IGNITE II CC, a partnership between the Duke University Center for Applied Genomics and Precision Medicine and the Duke Clinical Research Institute, will provide a central resource for coordination, cost-effective PCT design, adaptation, oversight, and integration for the network. Importantly, we will leverage our successful leadership of the IGNITE I Administrative CC and our deep expertise in coordination of PCTs. The members of the CC have notable experience in each area required by the RFA as: 1) a demonstration project AND Administrative CC for IGNITE I, 2) CC for large networks and genomic medicine studies, and 3) CC for PCTs. The IGNITE II CC will provide strategic organizational leadership for the development of a novel, flexible, and adaptable genomic medicine PCT platform, enables seamless communication, sharing of information to optimize network productivity. The CC will ensure optimal and adaptable PCT design, participant recruitment, and data collection, develop a comprehensive analysis framework for evaluating the implementation and clinical effectiveness of the genomic medicine interventions, and help disseminate of knowledge beyond the network. In addition, the CC will innovate in 1) the implementation of pragmatic trial designs, electronic data capture (EDC) systems, and improved recruitment strategies, 2) institution of common measures across the network, 3) creative management of affiliates as a force amplifier for the network, 4) developing a Genomic Medicine Knowledge Base for dissemination, 4) creating a durable longitudinal data source from IGNITE participants and 5) developing a focus on sustainability. Our team's unparalleled track record of collaborative genomic medicine research and nationally recognized expertise in coordinating IGNITE I, large networks, and PCTs uniquely positions us to facilitate the completion of high-impact genomic medicine PCTs and advance the integration of genomic into clinical care.