Novel Approaches to Advance Coordinated Registry Networks (CRNs).

项目摘要 新设备爆炸和迭代变革下的美国医疗技术变革 要求获取真实世界的证据（RWE），以务实地研究设备和技术。的 美国食品药品监督管理局（FDA）率先制定了RWE框架， 监管决策（如器械批准和监督）所需的充分证据。 自2015年国家医疗器械注册工作组成立以来， 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处 网络（CRN），开发或链接精心策划的国家RWE资源，如注册，行政， 和电子健康记录（EHR）数据。MDEPiNet是国家评价系统的重要合作伙伴 技术（NEST）协调中心，是一个国际公私合作伙伴关系，重点是 建立全球基础设施和方法，以促进RWE在医疗器械评价中的应用。 CRN不仅注重预防危害，还通过 开发研究设计，以比传统临床研究更低的成本加速患者招募 research. MDEPiNet为CRN开发了一个成熟度模型，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。 本提案的重点是创造必要的创新工具和方法， 通过高效管理强大的RWE建立网络。我们将充分利用与 登记处、专业协会、综合卫生系统和许多学术机构来推动这一进程。 关键的国家基础设施作为NEST的基本组成部分。我们将促进RWE的发展 通过利益相关者圆桌会议、面向患者的移动的应用程序开发以及持续创新的方法 开发将注册与医疗保险、商业、全州和EHR数据联系起来的系统，以实现更好的研究 和监视设备。我们的具体目标是促进利益相关者参与特定于设备的核心 妇女健康、前列腺癌、整形外科、血管疾病、机器人辅助 外科手术和颞下颌关节。我们还将推进和丰富血管相关数据的能力， 疾病，疝气修复，乳房植入体，前列腺癌，妇女健康和胃肠癌CRN。 最后，我们进行高级分析，以确定设备结果中的性别差异，并使用机器 学习和积极的监测方法，在疝修补术，整形外科，中风治疗，血管疾病， 女性健康CRN CRN实践社区将实现集中的知识共享， 跨专业和技术的学习和应用。通过这一点，我们使用 创新、可扩展和动态的方法，并帮助它们成为NEST的基础组件。

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.