ACC/Duke Partnership for a National Cardiovascular Research Infrastructure (NCRI)

描述（由申请人提供）：ARRA以及NIH临床路线图倡议已经阐明了对更高效和有效的临床研究基础设施的需求。目前国家临床研究模式效率低下的最大问题之一是研究人员缺乏持续的基础设施（包括共享资源、共同数据标准和有效利用信息技术）。临床研究者网络是打开国家临床研究能力的万能钥匙。我们建议在杜克临床研究所（DCRI）和美国心脏病学会（ACC）之间建立伙伴关系，以国家心血管数据登记处（NCDR）的数据收集活动为基础，建立一个临床研究者网络。这些登记以前被用于量化结果，并确定在美国提供高质量心血管患者护理方面的差距。我们寻求通过一个集中的临床研究网络来扩展和统一这些站点，通过加强站点招聘、培训、绩效和责任，并通过在临床研究受试者、临床医生研究者、专家指南委员会和政策制定者之间的互动中持续提高效率和质量，促进可互操作的临床研究。该方法有四个组成部分：首先，我们将实施项目和工具，重点建设网站能力，最终目标是提高临床研究网站的招聘、保留和表现。其次，我们将通过与临床数据交换标准联盟（CDISC）和NCDR合作，促进心血管临床研究的标准和互操作性。第三，我们将创建并实施一个提案开发系统，以最有效的方式征求和引入研究问题的最佳想法，从最初的概念到执行，包括适合政府，基金会或行业资助的准备，重点是鼓励公私合作伙伴关系。最后，我们将开发一个可以跨多个网络应用和使用的网络信息学基础设施，并提供一个集成的电子工具和程序存储库，以协助站点进行研究活动，同时促进站点和网络之间的交流。

DESCRIPTION (provided by applicant): The need for a more efficient and effective infrastructure for clinical research has been articulated by ARRA, as well as by the NIH clinical roadmap initiative. One of the greatest national inefficiencies of the current model of clinical research is the lack of a sustaining infrastructure (including shared resources, common data standards, and effective use of information technology) among researchers. Clinical investigator networks are the master key toward unlocking the nation's clinical research capacity. We propose a partnership between the Duke Clinical Research Institute (DCRI) and the American College of Cardiology (ACC) to develop a clinical investigator network based upon the data collection activities of the National Cardiovascular Data Registries (NCDR.) These registries have previously been used to quantify outcomes and identify gaps in the delivery of quality cardiovascular patient care in the United States. We seek to extend and unify these sites with a centralized clinical research network that will facilitates interoperable clinical research by enhancing site recruitment, training, performance, and accountability and by creating a sustained improvement in the efficiency and quality of the interaction between the clinical research subject, the clinician investigator, the expert guidelines committee, and policymakers. This approach has four components: First, we will implement programs and tools focused on building site capability with the ultimate goal of enhancing the recruitment, retention, and performance of clinical research sites. Second, we will facilitate standards and interoperability for cardiovascular clinical research through a partnership with the clinical data interchange standards consortium (CDISC) and the NCDR. Third, we will create and implement a proposal development system to solicit and bring the best ideas for research questions from initial concept to execution in the most efficient fashion, including preparation suitable for government, foundation, or industry funding, with a focus on encouraging public/private partnerships. Finally, we will develop a network informatics infrastructure that can be applied and used across multiple networks and provide an integrated electronic repository of tools and programs to assist the site in its study conduct activities while fostering communication across sites and networks. PUBLIC HEALTH RELEVANCE: The Duke Clinical Research Institute (DCRI) and the American College of Cardiology (ACC) propose a clinical investigator network based upon the data collection and informatics activities of the National Cardiovascular Data Registries (ACC-NCDR.) We will add randomization capabilities to the NCDR, thereby establishing a National Cardiovascular Research Infrastructure (NCRI). The NCRI will unify sites with a centralized clinical research network that will enhance site recruitment, training, performance, and accountability, and improve interactions between the clinical research subject, the clinician investigator, the expert guidelines committee, and policymakers.