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

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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.