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合作培育了21个 通过提供领导、资源、工具、培训和协调 元素。其中六项试验旨在加快解决国家阿片类药物问题的科学解决方案 公共卫生危机。协调委员会设有专家核心工作组和委员会；支持传播 并建立了《实用临床试验》在线生活教材进行翻译 为研究社区提供学习。合作实验室CC创建和传播了指导方针，以便 研究人员可以与卫生系统合作，将他们的研究嵌入到卫生保健的提供中，并使用 定期收集卫生保健信息，作为全系列临床研究的核心数据来源， 包括随机试验。合作实验室CC还为资助者、审查者、 机构审查委员会(IRBs)，以及关于道德和监管的数据安全监测委员会 嵌入式实用临床试验(EPCT)方面。 在下一阶段的工作中，我们将在吸取的经验教训和从下一套 继续完善务实试验模式的示范项目(目标1-3)。 在下一个供资期间，合作实验室CC将有以下具体目标： 具体目标1：与通过支持的每个示范项目团队协作 协作计划，包括他们的合作医疗保健系统，以开发、测试和实施 建议的示范项目，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、开发和传播成功实施嵌入式系统的最佳策略 通过使用医疗保健系统进行务实的临床试验-包括那些历史上参与较少的临床试验 研究性研究--作为研究合作伙伴，改善健康和护理服务。

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.