Pediatric Heart Disease Clinical Research Network - DCC

描述（由申请人提供） 儿科心脏病临床研究网络将是一个合作 多达六个临床中心的网络，一个数据协调中心（DCC），以及 NHLBI的心脏和血管疾病部门。具体目标是 该网络将有效地进行多中心临床研究， （包括但不限于随机临床试验），并评估新的 和现有的治疗和管理方法的儿童结构性 先天性心脏病，炎症性心脏病，心肌疾病， 和心律失常。DCC的作用是支持协议开发， 临床研究，提供统计学设计专业知识，识别， 培训和维护超声心动图和其他 心脏专科;收集和监测数据并提供质量 以人员培训和实地考察的形式提供保证; 总体研究协调，包括患者招募计划，以及 保存;分析收集的数据并促进快速传播 的研究结果。 新英格兰研究所（NERI）建议，在第一年， 网络资金，患者登记的心脏疾病最有可能 作为网络研究的重点，以促进 研究批准时的患者招募和模块化数据系统 开发可供网络有选择地使用的收集形式 在以后的几年里进行研究，以确保有效的启动。数据收集和数据 所有研究的管理将使用NERI？的专有基于Web的 ADEPT（Advanced Data Entry and Protocol Tracking System）网站 将立即访问研究中心特定的入组报告、患者 每名研究参与者的随访提醒和数据总结，NERI 提出了一个逐步的办法，有客观的标准来选择核心 实验室，并为关键人员提供医疗培训， 质量保证程序。NERI经验丰富的研究人员将 协调实验室样本的运输和电子提交 和心脏诊断数据NERI统计 团队在心脏病学领域拥有丰富的经验，将提供专家 指导观察性研究和随机试验的设计， 包括提前停止规则的设计， 建议收集成本效益数据，由NERI进行分析？S 健康经济学家NERI在多中心的各个领域都有丰富的经验 研究协调，更具体地说，目前协调一个 只有在儿科心脏病学领域的此类研究， 心肌病登记。

DESCRIPTION (provided by applicant) The Pediatric Heart Disease Clinical Research Network will be a cooperative network of up to six Clinical Centers, a Data Coordinating Center (DCC), and the Division of Heart and Vascular Diseases of the NHLBI. The specific aim of this network 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. The role of the DCC is to support protocol development for the clinical studies, to provide statistical design expertise, to identify, train, and maintain central laboratories for echocardiography and other cardiac specialties; to collect and monitor the data and provide quality assurance in the form of personnel training and site visits; to provide overall study coordination including plans for patient recruitment and retention; and to analyze the data collected and promote rapid dissemination of study findings. New England Research Institutes (NERI) proposes that in the first year of Network funding, that patient registries of the cardiac conditions most likely to be the focus of Network studies be established in order to facilitate patient recruitment at the time of study approval and a system of modular data collection forms be developed that can be selectively utilized by Network studies in later years to ensure efficient start-up. Data collection and data management for all studies will be conducted using NERI?s proprietary web-based system ADEPT (Advanced Data Entry and Protocol Tracking System). Sites will have immediate access to site-specific enrollment reports, patient follow-up reminders and data summaries on each study participant, NERI proposes a stepwise approach with objective criteria for the selection of core laboratories and offers key personnel with medical training for implementation of quality assurance procedures. Experienced research staff from NERI will coordinate both shipments and electronic submissions of laboratory specimens and diagnostic cardiac data for the core laboratories. The NERI statistical team has extensive experience in the field of cardiology will provide expert guidance in the design of both observational studies and randomized trials, including design of early stopping rules, This application also includes a proposal for collection of cost-effectiveness data to be analyzed by NERI?s health economist. NERI has extensive experience in all areas of multi-center study coordination and, more specifically, currently coordinates one of the only such studies in the field of pediatric cardiology, the Pediatric Cardiomyopathy Registry.