Pediatric Heart Network Children's Hospital of Philadelphia

费城儿童心脏网络儿童医院

基本信息

批准号：
10318603
负责人：
JAMES WILLIAM GAYNOR
金额：
$ 36.96万
依托单位：
CHILDREN'S HOSP OF PHILADELPHIA
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-01-01 至 2023-12-31
项目状态：
已结题

项目摘要

PROJECT SUMMARY Congenital cardiac malformations and acquired heart disease affect thousands of children each year. NHLBI established the PHN as a research enterprise in 2001, and it is now in its third grant cycle. The PHN has established best practices for multi-center research in pediatric cardiology and has completed 14 studies with 4 ongoing and an additional 3 nearing launch. There are multiple clinical trials and studies active at all times. In addition to performing observational studies and clinical trials, the PHN has supported nursing, health services, and quality improvement research and oversees a robust program of clinical research mentoring. The purpose of this proposal is to present the ability of The Children’s Hospital of Philadelphia (CHOP) to participate as a core Clinical Research Center in the PHN for the grant cycle beginning in Fiscal year 2017. CHOP and its Cardiac Center have been at the forefront of congenital and acquired cardiac research and innovation for decades. CHOP has been a Core Site for the PHN since its commencement. We are one of the few Core Sites to have participated in every PHN study to date. Almost without exception, CHOP has been the top or one of the top subject recruiters. Our large volume of subjects has been instrumental in the successful completion of a number of PHN projects. In the current grant cycle, CHOP was responsible for recruitment of 346 (18%) of the 1949 prospectively enrolled subjects in PHN studies. The PD/PIs for this submission have all been active participants in the PHN since its inception. They are currently the PD/PI team for CHOP and have developed a highly organized infrastructure with thorough oversight to manage the multiple PHN studies. These capabilities have made CHOP an integral part of the success of the PHN to date and would continue to do so in the future. Some of these resources include:  A proven record of the ability to effectively and efficiently manage all administrative activities, including leadership of multi-center clinical trials.  A proven ability to optimally conduct and support PHN activities and studies.  A large and varied patient population available for potential research.  An ability to identify, enroll and retain large numbers of participants in clinical trials.  A proven ability to interface with a variety of other cardiovascular databases and registries.  An extensive group of cardiac and non-cardiac clinical and research programs that can be leverage to aid in future PHN research activities.

项目概要先天性心脏畸形和后天性心脏病分别影响着数千名儿童 NHLBI 于 2001 年成立了 PHN 作为一家研究企业，目前已是第三家。 PHN 已建立了儿科多中心研究的最佳实践。心脏病学领域，已完成 14 项研究，其中 4 项正在进行，另外 3 项即将启动。除了执行之外，还有多项临床试验和研究始终处于活动状态。通过观察性研究和临床试验，PHN 支持护理、卫生服务和质量改进研究并监督强有力的临床研究指导计划。该提案的目的是展示费城儿童医院的能力 (CHOP) 作为 PHN 的核心临床研究中心参与资助周期从 2017 财年开始。 CHOP 及其心脏中心一直处于先天性和获得性心脏病治疗的前沿自成立以来，CHOP 一直是 PHN 的核心站点。我们是参与每项 PHN 研究的少数核心站点之一。几乎无一例外，CHOP 一直是我们的顶级学科招聘者之一。大量的科目有助于成功完成许多课程在当前的资助周期中，CHOP 负责招募 346 名 (18%) 的 PHN 项目。 1949 名前瞻性纳入 PHN 研究的受试者已提交本次提交的 PD/PI。自 PHN 成立以来，他们都是积极的参与者，目前是 PHN 的 PD/PI 团队。 CHOP 并开发了一个高度组织化的基础设施，并进行彻底的监督管理这些能力使 CHOP 成为成功的一个组成部分。迄今为止，并将在未来继续这样做，其中一些资源包括：  有效且高效地管理所有行政管理能力的经过验证的记录活动，包括领导多中心临床试验。  经证明有能力以最佳方式开展和支持 PHN 活动和研究。  大量不同的患者群体可用于潜在的研究。  能够识别、招募和保留大量临床试验参与者。  与各种其他心血管数据库连接的经过验证的能力注册表。  一组广泛的心脏和非心脏临床和研究项目，可以成为帮助未来 PHN 研究活动的杠杆。