NESTcc Renewal -Continuation of the National Evaluation System for Health Technology (NEST) Coordinating Center (CC)

NESTcc 更新 - 国家卫生技术评估系统 (NEST) 协调中心 (CC) 的延续

• 批准号: 10383166
• 负责人: Richard Smith
• 金额: $ 600万
• 依托单位: MEDICAL DEVICE INNOVATION CONSORTIUM
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-12-15 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10383166
• 关键词: NESTcc; Renewal; Continuation; National; Evaluation

PROJECT SUMMARY/ABSTRACT The Medical Device Innovation Consortium (MDIC) is applying to continue its role as the National Evaluation System for health Technology Coordinating Center (NESTcc). NESTcc is a cooperative network that consists of a coordinating center (MDIC), the U.S. Food and Drug Administration (FDA/CDRH), Network Collaborators, and a Governing Committee that represents the FDA, industry and their relevant trade associations, clinicians/clinician groups, academic health systems and research organizations, digital health and technology companies, payors, and patients/patient advocacy groups. The objectives of NESTcc are to: (1) Support implementation of NEST through sustainable multi-stakeholder partnerships; (2) Develop new systems of data collection/analysis to permit prospective active medical device postmarket risk identification; (3) Support the development of and access to high quality data sources that can be used in comprehensive evaluation of medical device performance and associated outcomes by multiple stakeholders; (4) Develop methodological approaches/systems that facilitates the use of real-world evidence for regulatory decision-making, and for uses by other stakeholders, throughout the entire device lifecycle. As NESTcc, MDIC will continue to provide robust scientific oversight and proven support for the next cycle of this grant, with key responsibilities for leadership in real-world evidence (RWE) research for the Research Network, operational and project management of research studies and projects, medical device safety (MDS) for active surveillance, Collaborative Community (CC); development and deployment of innovative infrastructure and tools; novel approaches for study design and statistical methodologies; and management and distribution of NEST funds. NESTcc will manage relationships among its partners to facilitate the use of RWD in understanding medical devices in a way that is meaningful for the stakeholder communities. NESTcc will monitor, promote, and facilitate infrastructure development for use of RWE for medical device evaluation, not just for regulatory decision-making but for the wider community of stakeholders. NESTcc will optimize the cost of, access to, quality of, and sharing of data related to medical device evaluation; promote the adoption of best practices using RWE; develop a transparent and streamlined process for evaluating and disseminating medical device safety and effectiveness information; and develop a sustainable business model. Our proposed approach represents a strong, experienced leadership team to ensure efficient scientific and administrative support to NEST using advanced and innovative technologies. A multiple PI leadership plan is proposed shared by Pamela Goldberg (MDIC CEO) and Flora Sandra Siami (MDIC SVP and head of NESTcc), with clearly delineated roles and responsibilities for leading and directing NESTcc.

项目摘要/摘要 医疗器械创新联盟（MDIC）正在申请继续其作为国家评估机构的角色。 卫生技术协调中心系统（NESTcc）。NESTcc是一个合作网络，由一个 协调中心（MDIC）、美国食品药品监督管理局（FDA/CDRH）、网络合作者和 代表FDA、行业及其相关行业协会、临床医生/临床医生的管理委员会 团体，学术卫生系统和研究组织，数字健康和技术公司，付款人， 和患者/患者倡导团体。 NEST cc的目标是：（1）通过可持续的多方利益攸关方支持NEST的实施 （2）开发新的数据收集/分析系统，以允许预期的有源医疗器械 上市后风险识别;（3）支持开发和访问高质量数据源， 用于通过多个指标对医疗器械性能和相关结局进行综合评价 （4）制定方法/系统，促进使用真实世界的证据， 在整个器械生命周期中，监管决策以及其他利益相关者使用。 作为NESTcc，MDIC将继续为下一个周期提供强有力的科学监督和经证实的支持。 这项补助金，与领导的关键责任，在现实世界的证据（RWE）研究的研究 研究和项目的网络、运营和项目管理，医疗器械安全（MDS）， 主动监控、协作社区（CC）;开发和部署创新基础设施， 工具;研究设计和统计方法的新方法;以及NEST的管理和分发 资金NESTcc将管理其合作伙伴之间的关系，以促进使用RWD了解医疗 以一种对利益相关者社区有意义的方式使用设备。NESTcc将监测、促进和促进 为使用RWE进行医疗器械评价而不仅仅是监管决策开发基础设施 而是为了更广泛的利益相关者。NESTcc将优化成本，获取，质量和共享 与医疗器械评价相关的数据;促进采用RWE最佳实践;制定 用于评估和传播医疗器械安全性和有效性的透明且简化的流程 信息化;发展可持续的商业模式。我们提出的方法代表了一个强大的，经验丰富的 领导团队，以确保有效的科学和行政支持NEST使用先进的和创新的 技术. Pamela Goldberg（MDIC首席执行官）和植物群Sandra Siami共同提出了多PI领导计划 (MDIC高级副总裁兼NESTcc负责人），明确界定领导和指导NESTcc的角色和责任。