Pediatric Heart Network: Data Coordinating Center

描述（由申请人提供）： 本申请描述了新英格兰研究所（NERI）作为儿科心脏病临床研究网络（PHN）延续的拟议数据协调中心的作用。PHN的具体目标是有效地进行多中心临床研究（包括但不限于随机临床试验），并评估结构性先天性心脏病，炎症性心脏病，心肌疾病和心律失常儿童的新的和现有的治疗和管理方法。自PHN成立以来，NERI一直担任PHN数据协调中心，为该网络的科学成就做出了贡献，并为该网络的开展制定和实施了行政，数据管理统计和技术流程，目前包括7个临床中心和7个辅助中心。作为PHN DCC，NERI将继续协调所有PHN委员会的活动，维护和加强安全网络和公共网站，为研究设计和数据分析（包括临床、替代和成本结果）提供统计专业知识，监测患者安全性，监督监管要求，并根据需要提交监管/安全性报告。NERI还将加强其专有的基于Web的数据管理系统ADEPT（高级数据输入和协议跟踪），以适应新的研究，执行选择和实施网络研究的多个核心实验室的程序，并通过对诊所工作人员的集中培训，现场访问和专业实验室协议来实践良好的质量保证技术。在更新期间，NERI还将利用其现有的基础设施，由于其与几个NIH网络的经验，管理临床中心的患者护理基金，并传播PHN研究的结果。NERI将在PHN DCC现有系统的基础上，利用其经验丰富的行政、数据管理和编程、统计和临床/监管团队完成3项正在进行的PHN研究，并在新的资助期内启动至少3项新研究。儿科心脏病临床研究网络将通过提供资源以多中心方式进行研究，对儿科心脏病学领域的进步产生直接影响，这将提供足够的患者来评估有关该患者人群管理和治疗的重要假设，并将这些发现迅速传播给儿科和心脏病学社区。 (End摘要）

DESCRIPTION (provided by applicant): This application describes the role of New England Research Institutes (NERI) as the proposed Data Coordinating Center for continuation of the Pediatric Heart Disease Clinical Research Network (PHN). The specific aim of the PHN is to efficiently conduct multi-center clinical studies (including but not limited to randomized clinical trials), and to evaluate new and existing treatments and management approaches for children with structural congenital heart disease, inflammatory heart disease, heart muscle disease, and arrhythmias. NERI has served as the PHN Data Coordinating Center since the inception of the PHN and has contributed to the scientific accomplishments of the network as well as developed and implemented administrative, data management statistical, and technical processes for the conduct of this network, which currently includes 7 clinical centers and 7 auxiliary centers. As the PHN DCC, NERI will continue to coordinate the activities of all PHN committees, maintain and enhance secure network and public websites, provide statistical expertise for study design and data analysis (including clinical, surrogate, and cost outcomes), monitor patient safety and oversee regulatory requirements and submit regulatory/safety reports as needed. NERI will also enhance the its proprietary Web-based data management system, ADEPT (Advanced Data Entry and Protocol Tracking), to accommodate new studies, execute procedures for the selection and implementation of multiple core laboratories for network studies, and practice good quality assurance technique via central training of clinic staff, site visits, and specialized laboratory protocols. In the renewal period, NERI will also utilize its existing infrastructure due its experience with several NIH networks to administer patient care funds to clinical centers and disseminate the results of PHN research. NERI will build upon the systems already in place as the PHN DCC and utilize its experienced Administrative, Data Management & Programming, Statistical, and Clinical/Regulatory Teams to complete 3 ongoing PHN studies and initiate at least 3 new studies in the new grant period. The Pediatric Heart Disease Clinical Research Network will have a direct impact on advances in the field of pediatric cardiology by providing the resources to conduct studies in a multi-center fashion, which will provide sufficient patients to evaluate important hypotheses regarding management and therapy in this patient population and prompt dissemination of these findings to the pediatric and cardiology communities. (End of Abstract)