NIH Health Care Systems Research Collaboratory-Coordinating Center (U24)

摘要 在过去的九年里，合作实验室协调中心（CC）与NIH合作， 示范项目通过提供领导、资源、工具、培训和协调不同的 元素其中六项试验旨在加快解决国家阿片类药物滥用问题的科学解决方案。 公共卫生危机。协调委员会维持专家核心工作组和委员会;支持传播 和实施工作;并建立了实用临床试验在线生活教科书， 为研究社区提供学习。协作中心制定并传播了指导意见， 研究人员可以与卫生系统合作，将他们的研究嵌入到医疗保健的提供中，并使用 常规收集的医疗保健信息作为全方位临床研究的核心数据源， 包括随机试验。合作实验室CC还为资助者、评审者、 机构审查委员会（IRB）以及有关道德和监管的数据安全监测委员会 嵌入式实用临床试验（ePCTs）。 在下一阶段的工作中，我们将借鉴从下一组 继续完善务实的审判模式（目标1-3）。 在下一个资助期内，协作中心将有以下具体目标： 具体目标1：与每个示范项目团队合作， 合作实验室计划，包括他们的合作医疗保健系统，以开发，测试和实施 建议示范项目，同时提供技术，设计和协调支持。 具体目标2：进一步制定和完善技术和政策准则及最佳做法， 与卫生保健系统合作，有效开展研究。 具体目标3：学习、发展和传播成功实施嵌入式教育的最佳策略 务实的临床试验，通过参与医疗保健系统，包括那些历史参与较少， 研究-作为研究伙伴，改善卫生和保健服务。

ABSTRACT Over the past nine years, the Collaboratory Coordinating Center (CC) has worked with the NIH to nurture 21 Demonstration Projects by providing leadership, resources, tools, training, and coordination of diverse elements. Six of these trials were designed to speed scientific solutions for addressing the national opioid public health crisis. The CC maintains expert Core Working Groups and committees; supports dissemination and implementation efforts; and established the online Living Textbook of Pragmatic Clinical Trials to translate learnings for the research community. The Collaboratory CC has created and disseminated guidance so that investigators can work with health systems to embed their research in the delivery of health care, and use routinely collected health care information as a core data source for the full spectrum of clinical research, including randomized trials. The Collaboratory CC is also providing essential guidance to funders, reviewers, institutional review boards (IRBs), and data safety monitoring boards regarding the ethical and regulatory aspects of embedded pragmatic clinical trials (ePCTs). In this next phase of work, we will build on lessons learned and new experiences gleaned from the next set of Demonstration Projects to continue to refine the pragmatic trials model (Aims 1-3). During the next funding period, the Collaboratory CC will have the following Specific Aims: Specific Aim 1: 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 2: Further develop and refine technical and policy guidelines and best practices for the effective conduct of research studies in partnership with health care systems. Specific Aim 3: Learn, develop, and disseminate the best strategies for conducting successful embedded pragmatic clinical trials by engaging health care systems—including those with less historical involvement in research studies—as research partners to improve health and care delivery.