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 医疗设备创新联盟（MDIC）正在申请继续其作为国家评估的角色 卫生技术协调中心（NESTCC）系统。 NESTCC是一个合作网络，由 协调中心（MDIC），美国食品和药物管理局（FDA/CDRH），网络合作者和A 代表FDA，行业及其相关行业协会，临床医生/临床医生的理事委员会 小组，学术卫生系统和研究组织，数字健康和技术公司，付款人， 以及患者/患者倡导组。 NESTCC的目标是：（1）通过可持续的多利益相关者支持Nest实施 伙伴关系； （2）开发新的数据收集/分析系统以允许潜在的主动医疗设备 后市场风险识别； （3）支持可能是高质量数据源的开发和访问 用于全面评估医疗设备的性能和相关结果 利益相关者； （4）开发方法论方法/系统，以促进现实世界证据的使用 整个设备生命周期中，监管决策以及其他利益相关者的用途。 作为NESTCC，MDIC将继续提供强大的科学监督，并为下一个周期提供证明的支持 这项赠款，负责实际证据中的领导责任（RWE）研究 网络，运营和项目管理研究与项目的管理，医疗设备安全（MDS）的网络和项目管理 主动监视，合作社区（CC）；创新基础设施的开发和部署 工具;研究设计和统计方法的新方法；以及巢的管理和分配 资金。 NESTCC将管理其合作伙伴之间的关系，以促进RWD在理解医学方面 设备以对利益相关者社区有意义的方式。 NESTCC将监视，促进和促进 使用RWE进行医疗设备评估的基础设施开发，而不仅仅是用于监管决策 但是对于更广泛的利益相关者社区。 NESTCC将优化，访问，质量和共享的成本，共享 与医疗设备评估有关的数据；使用RWE促进采用最佳实践；开发 评估和传播医疗设备安全性和有效性的透明和简化过程 信息;并开发可持续的商业模式。我们提出的方法代表了一个强大，经验丰富的 领导团队，以确保使用高级和创新的有效的科学和行政支持巢 技术。 Pamela Goldberg（MDIC首席执行官）和Flora Sandra Siami提出了一项多重PI领导计划 （MDIC SVP和NESTCC负责人），明确划定了领导和指导NestCC的角色和职责。