Pediatric Heart Disease Clinical Research Network - DCC

小儿心脏病临床研究网络 - DCC

• 批准号: 6795479
• 负责人: LYNN A SLEEPER
• 金额: $ 239.93万
• 依托单位: NEW ENGLAND RESEARCH INSTITUTES, INC.
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-06 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6795479
• 关键词: arrhythmia; cardiovascular disorder therapy; child (0-11); clinical trials; congenital heart disorder; cooperative study; data management; human subject; human therapy evaluation; inflammation; myocardium disorder; patient care management; patient oriented research; pediatrics

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.

描述（由申请人提供） 小儿心脏病临床研究网络将成为一个合作社 由多达六个临床中心、一个数据协调中心 (DCC) 和 NHLBI 心脏和血管疾病科。具体目标是 该网络旨在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 以及结构性儿童现有的治疗和管理方法 先天性心脏病、炎症性心脏病、心肌病、 和心律失常。 DCC 的作用是支持协议开发 临床研究，提供统计设计专业知识，识别， 培训和维护超声心动图和其他中心实验室 心脏专科；收集和监控数据并提供质量 以人员培训和实地考察的形式提供保证；提供 总体研究协调，包括患者招募计划和 保留;并对收集到的数据进行分析并促进快速传播 研究结果。 新英格兰研究机构 (NERI) 提议在第一年 网络资助，最有可能的心脏病患者登记 成为网络研究的重点，以促进 研究批准时的患者招募和模块化数据系统 开发可供网络选择性使用的收集形式 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 专有的网络进行 系统 ADEPT（高级数据输入和协议跟踪系统）。站点 将可以立即访问特定地点的登记报告、患者 每个研究参与者的后续提醒和数据摘要，NERI 提出了一种具有客观标准的逐步方法来选择核心 实验室并为关键人员提供实施医疗培训 质量保证程序。 NERI 经验丰富的研究人员将 协调实验室标本的运输和电子提交 以及核心实验室的诊断心脏数据。 NERI统计 团队在心脏病学领域拥有丰富的经验，将提供专家 观察性研究和随机试验设计的指导， 包括早期停止规则的设计，该应用程序还包括 关于收集成本效益数据供 NERI 分析的提案 健康经济学家。 NERI 在多中心的各个领域都拥有丰富的经验 研究协调，更具体地说，目前协调其中一项 只有儿科心脏病学领域的此类研究，儿科 心肌病登记处。