Novel Approaches to Advance Coordinated Registry Networks (CRNs).

项目摘要 随着新设备的爆炸和迭代变化，美国医疗保健的技术变革 要求获取真实世界的证据(RWE)，以务实地研究设备和技术。这个 美国食品和药物管理局(FDA)带头开发RWE框架，以追求 制定监管决策所需的足够证据，如设备审批和监控。 自2015年国家医疗器械注册工作组成立以来，在监管部门的支持下， 医疗器械流行病学网络(MDEpiNet)创建了15个国家和国际协调登记 网络(CRN)，开发或连接精心策划的国家RWE来源，如登记处、行政部门、 和电子健康记录(EHR)数据。MDEpiNet是国家评估系统的关键合作伙伴 技术(Nest)协调中心，是一个国际公私合作伙伴关系，专注于 建立全球基础设施和方法，以促进医疗器械评估中莱茵集团的使用。 CRN不仅专注于预防危害，还通过 开发研究设计，以比传统临床更低的成本加快患者招募 研究。MDEpiNet开发了CRN的成熟度模型，在七个关键方面取得了不同程度的成就 领域：1)设备识别，2)质量改进，3)整个产品生命周期，4)数据质量，5) 效率，6)治理和可持续性，7)患者参与度。 这项建议侧重于创造必要的创新工具和方法，以实现成熟的 通过对稳健的RWE进行有效的管理，实现对网络的支持。我们将利用已建立的合作伙伴关系 登记处、专业协会、综合保健系统和许多学术机构，以促进这一点 关键的国家基础设施是Nest的基本组成部分。我们将推动莱茵集团的发展 通过利益相关者圆桌会议、面向患者的移动应用程序开发和持续创新的方法 开发将登记处与Medicare、商业、全州和EHR数据联系起来，以实现更好的研究 以及对设备的监控。我们的具体目标促进了利益相关者对设备特定核心的参与 在妇女健康、前列腺癌、骨科、血管疾病、机器人辅助方面的最低数据开发 外科手术和颞颌关节。我们还将推进和丰富血管领域的关联数据能力 疾病、疝气修复、乳房植入、前列腺癌、妇女健康和胃肠癌CRN。 最后，我们进行高级分析以确定设备结果和使用机器的性别差异 在疝修补术、矫形外科、中风治疗、血管疾病以及 妇女健康CRN。CRN实践社区将实现集中的知识共享，以支持 跨专业和技术学习与应用。通过这种方式，我们使用以下方法推进CRN 创新、可扩展和动态的方法，并帮助它们成为Nest的基本组件。

Project Summary The technological transformation of US health care with the explosion of new devices and iterative changes mandates the acquisition of real-world evidence (RWE) to study devices and technologies pragmatically. The US Food and Drug Administration (FDA) has spearheaded the RWE framework development in the pursuit of sufficient evidence that is required for regulatory decision-making such as device approvals and surveillance. With regulatory support since the launch of the National Medical Device Registry Task Force in 2015, the Medical Device Epidemiology Network (MDEpiNet) created 15 national and international coordinated registry networks (CRNs), which develop or link well-curated national RWE sources such as registries, administrative, and electronic health records (EHRs) data. The MDEpiNet is a key partner of the National Evaluation System of Technologies (NEST) coordinating center and is an international public-private partnership focusing on building global infrastructure and methodologies to advance the use of RWE for medical device evaluation. CRNs not only focus on prevention of harms but also the promotion of safer device innovation through the development of study designs that expedites patient recruitment at lower costs than traditional clinical research. MDEpiNet developed a maturity model for CRNs with various levels of achievements in seven key domains: 1) device identification, 2) quality improvement, 3) total product life-cycle, 4) data quality, 5) efficiency, 6) governance and sustainability, 7) patient engagement. This proposal focuses on the creation of innovative tools and methods necessary to achieve maturation of the networks through efficient curation of robust RWE. We will capitalize on established partnerships with registries, professional societies, integrated health systems, and many academic institutions to advance this critical national infrastructure as a foundational component of NEST. We will facilitate advancements of RWE through stakeholder roundtables, patient-facing mobile app development, and continued innovative methods development to link registries with Medicare, commercial, statewide, and EHR data to enable better research and surveillance for devices. Our specific aims facilitate stakeholder engagement for device-specific core minimum data development in women's health, prostate cancer, orthopedics, vascular disease, robot-assisted surgery, and temporomandibular joints. We will also advance and enrich linked data capacities in vascular disease, hernia repair, breast implant, prostate cancer, Women's Health, and gastrointestinal cancer CRNs. Finally, we conduct advanced analytics to determine gender disparities in device outcomes and use machine learning and active surveillance methods in hernia repair, orthopedics, stroke treatment, vascular disease, and Women's health CRNs. The CRN community of practice will enable centralized knowledge sharing to support cross-specialty and technology learning and applications. Through this, we advance the CRNs using innovative, scalable, and dynamic approaches and help them become foundational components of NEST.