NIH Health Care Systems Research Collaboratory - Coordinating Center

项目概要 在过去的 5 年里，美国国立卫生研究院 (NIH) 建立了医疗保健系统研究中心 合作实验室（Collaboratory）致力于加强国家能力，以实施具有成本效益的大规模 让医疗保健提供组织作为研究伙伴的规模研究。合作实验室 包括一个协调中心（合作实验室 CC），与 NIH 合作制作、文件、 传播标准并创建持久的基础设施以促进多地点务实研究和再利用 来自临床环境的电子医疗保健数据为医疗保健决策提供信息。这个程序成为了 具有成本效益的协作研究模型，可以为学习健康奠定基础 护理系统。正如合作实验室所证明的那样，真实世界的证据生成是 改变临床研究的进行方式，并在此势头的基础上继续保持领先的国家地位 优先（Califf NEJM 2016）。下一阶段，合作CC将继续努力， 承担制定和传播普遍经验教训的关键责任 嵌入式实用临床试验 (ePCT)，并能够扩展 ePCT 以促进学习 卫生系统。下一阶段的一个重要部分将是收集数据以估计 ePCT 的价值。这个 知识将有助于促进各利益攸关方采用 ePCT 研究方法，包括 研究赞助者、监管者、卫生计划执行者、卫生系统领导者、患者、科学界 成员和临床研究人员。考虑到合作实验室迄今为止的进展和未来的优先事项， 协作 CC 将具有以下具体目标： 具体目标 1：进一步开发、适应和采用 有效开展伙伴关系研究的技术和政策准则以及最佳做法 与医疗保健系统。具体目标 2：与每个示范项目团队协作 通过合作计划（包括其合作医疗保健系统）提供支持，以开发、测试、 并实施拟议的示范项目，同时提供技术、设计和协调 支持。具体目标 3：学习并传播让医疗保健系统参与的最佳策略 研究合作伙伴改善健康和护理服务。具体目标 4：学习、开发和传播 在医疗保健系统中进行务实临床试验以提高科学界的最佳方法 进行未来实用试验的能力。

Project Summary Over the past 5 years, the National Institutes of Health (NIH) established a Health Care Systems Research Collaboratory (Collaboratory) worked to strengthen the national capacity to implement cost-effective large- scale research studies that engage health care delivery organizations as research partners. The Collaboratory included a Coordinating Center (Collaboratory CC) that worked with the NIH to produce, documents, disseminate standards, and create durable infrastructure to facilitate multisite pragmatic studies and the reuse of electronic health care data from clinical settings to inform health care decisions. This program became a model for the type of cost-efficient, collaborative research that can build the foundation for a learning health care system. Real-world evidence generation, as has been demonstrated through the Collaboratory, is transforming the way clinical research is conducted, and building on this momentum remains a top national priority (Califf NEJM 2016). In the next phase, the Collaboratory CC intends to continue its efforts and undertake the critical responsibility of developing and disseminating generalizable lessons learned about embedded pragmatic clinical trials (ePCTs), and to enable the expansion of ePCTs in promotion of a learning health system. An important part of this next phase will be gathering data to estimate the value of ePCTs. This knowledge will help to promote the uptake of ePCT research methods by various stakeholders, including research sponsors, regulators, health plan executives, health system leaders, patients, scientific community members, and clinical researchers. Considering the Collaboratory's progress to date and future priorities, the Collaboratory CC will have the following Specific Aims: Specific Aim 1: Further develop, adapt and adopt technical and policy guidelines and best practices for the effective conduct of research studies in partnership with health care systems. Specific Aim 2: Work collaboratively with each Demonstration Project team supported through the Collaboratory program, including their partnering health care systems, to develop, test, and implement the proposed Demonstration Projects while providing technical, design, and coordination support. Specific Aim 3: Learn and disseminate the best strategies for engaging health care systems as research partners to improve health and care delivery. Specific Aim 4: Learn, develop, and disseminate the best means of conducting pragmatic clinical trials in health care systems to improve the scientific community's ability to perform future pragmatic trials.