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.

实现必要的，强大的和不断发展的证据基础，为基因组医学及其 在临床实践中的实施需要克服许多实践和后勤挑战。的 在实践中实施GeNomics（IGNITE）网络一直是并将继续是确定 并传播应对这些挑战的解决方案。具体而言，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， 决策支持IGNITE在实现其目标方面的有效性需要一个经验丰富， 有组织的协调中心（CC）与基因组医学有着密切的联系，可以招募参与者， 为实用的临床试验（PCT）创建大量的最佳实践资源，开发和部署通用的 措施和标准，确定解决执行中挑战的办法，建立数据平台， 管理和数据分析，并向更大的社区传播知识。提议的点火 II CC是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、成本效益高的PCT设计提供中心资源， 网络的适应、监督和整合。重要的是，我们将利用我们成功的 IGNITE I行政协调委员会的领导以及我们在协调PCT方面的深厚专业知识。的 协调委员会的成员在RFA要求的每个领域都有显著的经验：1）示范项目 和IGNITE I的行政CC，2）大型网络和基因组医学研究的CC，以及3） 多氯联苯。IGNITE II CC将为小说的开发提供战略组织领导， 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。合作委员会将确保最佳和适应性强的PCT设计， 招聘和数据收集，制定一个全面的分析框架，以评估 基因组医学干预措施的实施和临床有效性，并帮助传播 网络之外的知识。此外，消委会还将在以下方面进行创新：1）务实审判 设计、电子数据采集系统和改进的征聘战略，2）建立共同的 在整个网络的措施，3）创造性地管理子公司作为网络的力量放大器，4） 开发基因组医学知识库，4）创建持久的纵向数据 来源IGNITE参与者和5）发展可持续性的重点。我们队无与伦比的赛道 协作基因组医学研究的记录和国家认可的协调IGNITE的专业知识 I、大型网络和PCT使我们能够独特地促进高影响力基因组医学的完成 PCTs和推进基因组整合到临床护理。