NIH Health Care Systems Research Collaboratory - Coordinating Center

项目摘要 在过去的5年里，美国国立卫生研究院（NIH）建立了一个医疗保健系统研究 合作实验室（合作实验室）努力加强国家能力，以实施具有成本效益的大型 将医疗保健提供机构作为研究合作伙伴参与的规模研究。合作实验室 包括一个协调中心（合作实验室CC），与NIH合作，生产，文件， 传播标准，并创建持久的基础设施，以促进多站点的实用研究和重用 从临床环境中收集电子医疗保健数据，为医疗保健决策提供信息。该计划成为一个 一种具有成本效益的合作研究模式，可以为学习健康奠定基础 护理系统。正如协作实验室所展示的那样， 改变临床研究的进行方式，并在此基础上建立一个顶级的国家 优先级（Califf NEJM 2016）。在下一阶段，合作实验室协调委员会打算继续努力， 承担重要责任，发展和传播在以下方面吸取的可推广的经验教训： 嵌入式实用临床试验（ePCT），并使ePCT的扩展，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 知识将有助于促进各利益相关者采用ePCT研究方法，包括 研究赞助商、监管机构、健康计划执行人员、卫生系统领导人、患者、科学界 成员和临床研究人员。考虑到合作实验室迄今取得的进展和今后的优先事项， 合作实验室CC将有以下具体目标：具体目标1：进一步发展，适应和采用 有效开展研究的技术和政策准则及最佳做法 医疗保健系统。具体目标2：与每个示范项目团队合作 通过合作实验室计划的支持，包括他们的合作医疗保健系统，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：学习和传播使卫生保健系统参与的最佳战略， 研究合作伙伴，以改善健康和护理服务。具体目标4：学习、发展和传播 在医疗保健系统中进行实用临床试验的最佳方法，以提高科学界的 有能力进行未来的务实试验。

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.