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

IGNITE II CC：参与、协调、示范和传播

• 批准号: 10827791
• 负责人: Hrishikesh Chakraborty
• 金额: $ 351.09万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10827791
• 关键词: Acceleration; Accountability; Address; Administrative Coordination; Amplifiers; Area; Case Report Form; ClinVar; Clinical; Clinical Research; Clinical Trials Data Monitoring Committees; Clinical Trials Design; Clinical Trials Network; Clinical effectiveness; Collaborations; Communication; Communities; Community Medicine; Consent; Cost Effectiveness Analysis; Creativeness; Data; Data Analyses; Data Collection; Data Management Resources; Data Sources; Databases; Discipline; Documentation; Effectiveness; Enrollment; Ensure; Environment; Fostering; Genomic medicine; Genomics; Goals; Information Technology; Infrastructure; Institution; Institutional Review Boards; International; Intervention; Intranet; Knowledge; Leadership; Learning; Measures; Monitor; Office of Administrative Management; Online Systems; Ownership; Participant; Patient Recruitments; Positioning Attribute; Pragmatic clinical trial; Problem Solving; Productivity; Protocols documentation; Publications; Quality Control; Reporting; Research; Research Institute; Resources; Risk; Sample Size; Standardization; Statistical Data Interpretation; Structure; Time; Training; Translations; United States National Institutes of Health; Universities; Vision; Work; Writing; catalyst; clinical care; clinical practice; cost effective; dashboard; data interoperability; data management; data quality; data standards; database of Genotypes and Phenotypes; design; effective intervention; electronic data capture system; evidence base; experience; falls; flexibility; genome sciences; genomic data; implementation evaluation; implementation facilitation; implementation/effectiveness; improved; innovation; insight; knowledge base; knowledge hub; knowledge translation; leadership development; material transfer agreement; meetings; member; novel; phenotypic data; pragmatic implementation; precision medicine; programs; quality assurance; recruit; success; synergism; tool; translational genomics; trial design; uptake; working group

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.

为基因组医学及其相关领域获得必要的、稳健的、不断发展的证据基础 在临床实践中的实施需要克服许多实际和后勤方面的挑战。这 在实践中实施基因组学 (IGNITE) 网络已经并将继续在识别基因组学方面具有战略意义 并传播应对这些挑战的解决方案。具体来说，我们将继续解决缺乏 信息技术基础设施支撑不足，数据标准和互操作性不足， 决策支持。 IGNITE 要想有效地实现其目标，需要经验丰富、能力出色的人员 有组织的协调中心（CC）与基因组医学现有紧密联系，可以招募参与者， 为实用临床试验 (PCT) 创建大量最佳实践资源，开发和部署通用的 措施和标准，确定实施中挑战的解决方案，开发数据平台 管理和数据分析，并向更大的社区传播知识。拟议的点燃 II CC，杜克大学应用基因组学和精准医学中心与 杜克临床研究所将为协调、具有成本效益的 PCT 设计提供中央资源， 网络的适应、监督和整合。重要的是，我们将利用我们的成功经验 IGNITE I 行政 CC 的领导力以及我们在协调 PCT 方面的深厚专业知识。这 CC 成员在 RFA 要求的每个领域都拥有丰富的经验，例如：1) 示范项目 以及 IGNITE I 的行政 CC，2) 用于大型网络和基因组医学研究的 CC，以及 3) 用于 PCT。 IGNITE II CC 将为开发新颖的、 灵活、适应性强的基因组医学PCT平台，实现无缝沟通、共享 优化网络生产力的信息。 CC 将确保最佳且适应性强的 PCT 设计、参与者 招聘和数据收集，开发一个全面的分析框架来评估 基因组医学干预措施的实施和临床效果，并帮助传播 超越网络的知识。此外，CC还将在1）实施务实试点方面进行创新。 设计、电子数据采集 (EDC) 系统和改进的招聘策略，2) 共同制度 整个网络的措施，3) 作为网络力量放大器的附属机构的创造性管理，4) 开发基因组医学知识库进行传播，4）创建持久的纵向数据 来自 IGNITE 参与者的信息以及 5) 关注可持续性。我们团队无与伦比的赛道 合作基因组医学研究的记录和国家认可的 IGNITE 协调专业知识 I、大型网络和 PCT 使我们处于独特的地位，有助于完成高影响力的基因组医学 PCT 并促进基因组与临床护理的整合。