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

摘要 获得必要的、强大的和不断发展的基因组医学及其证据基础 在临床实践中的实施需要克服许多实际和后勤挑战。这个 在实践中实施基因组学(INIGITE)网络一直并将继续在识别 并传播应对这些挑战的解决方案。具体地说，我们将继续解决缺乏 支持信息技术基础设施，缺乏数据标准和互操作性，且不足 决策支持。要有效地实现IGNITE的目标，需要一位经验丰富的- 与基因组医学有很强联系的有组织的协调中心(CC)，可以招募参与者， 为务实的临床试验(PCT)创建大量最佳实践资源，开发和部署通用 措施和标准，确定实施挑战的解决方案，开发数据平台 管理和数据分析，并向更广泛的社区传播知识。建议的点火装置 II CC，杜克大学应用基因组学和精密医学中心与 杜克临床研究所将为协调、经济高效的PCT设计提供中央资源， 网络的适应、监督和整合。重要的是，我们将利用我们成功的 INITE I行政协调委员会的领导和我们在协调PCT方面的深厚专业知识。这个 CC成员在RFA要求的每个领域都有显著的经验，如：1)示范项目 和行政CC，用于IGNITE I，2)CC用于大型网络和基因组医学研究，以及3)CC用于 PCTS。IGNITE II CC将为开发一种新的、 灵活、适应性强的基因组药物PCT平台，使无缝交流、共享 用于优化网络工作效率的信息。CC将确保PCT设计的最优化和适应性，参与者 征聘和数据收集，制定一个全面的分析框架，以评价 基因医学干预措施的实施和临床效果，并帮助传播 网络之外的知识。此外，CC还将在1)实施务实审判方面进行创新 设计、电子数据采集系统和改进的征聘战略；2)共同制度 跨网络的措施，3)创造性地管理分支机构，作为网络的力量放大器，4) 开发用于传播的基因组医学知识库，4)创建持久的纵向数据 来自IGNITE参与者和5)发展对可持续发展的关注。我们队无与伦比的赛道 协作基因组医学研究记录和国家认可的协调IGNITE的专业知识 I、大型网络和PCT使我们能够为完成高影响力的基因组医学提供独特的条件 PCT，并推进基因组与临床护理的整合。

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.