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临床研究更高效和有效基础设施的需求。当前临床研究模式的最大国家效率低下之一是研究人员之间缺乏可持续的基础设施（包括共享资源，通用数据标准和有效使用信息技术）。临床研究者网络是开启国家临床研究能力的万能钥匙。我们建议杜克临床研究所（DCRI）和美国心脏病学会（ACC）建立合作伙伴关系，以国家心血管数据登记处（NCDR）的数据收集活动为基础，建立临床研究者网络。这些登记研究以前曾被用于量化结果，并确定在美国提供优质心血管患者护理的差距。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，该网络将通过加强站点招聘、培训、绩效和问责制以及通过持续改善临床研究受试者、临床研究者、专家指南委员会和政策制定者之间的互动效率和质量来促进可互操作的临床研究。该方法有四个组成部分：首先，我们将实施专注于建设研究中心能力的计划和工具，最终目标是提高临床研究中心的招募、保留和绩效。其次，我们将通过与临床数据交换标准联盟（CDISC）和NCDR的合作，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并将研究问题从最初的概念到执行的最佳想法，包括适合政府，基金会或行业资助的准备，重点是鼓励公共/私人合作伙伴关系。最后，我们将开发可在多个网络中应用和使用的网络信息学基础设施，并提供工具和程序的集成电子存储库，以协助研究中心开展研究活动，同时促进研究中心和网络之间的沟通。 公共卫生相关性：杜克临床研究所（DCRI）和美国心脏病学会（ACC）提出了一个基于国家心血管数据登记中心（ACC-NCDR）的数据收集和信息活动的临床研究者网络。我们将在NCDR中增加随机化功能，从而建立国家心血管研究基础设施（NCRI）。NCRI将通过一个集中的临床研究网络统一研究中心，该网络将加强研究中心的招募、培训、绩效和问责制，并改善临床研究受试者、临床研究者、专家指南委员会和政策制定者之间的互动。

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.