Pediatric Heart Network Children's Hospital of Philadelphia

费城儿童心脏网络儿童医院

• 批准号: 10078968
• 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
• 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
• 来源: https://reporter.nih.gov/project-details/10078968
• 关键词: Affect; Cardiac; Cardiovascular system; Child; Childhood; Clinical Research; Clinical Trials; Databases; Discipline of Nursing; Enrollment; Funding Opportunities; Future; Grant; Health Services; Heart; Heart Diseases; Heart Research; Infrastructure; Institution; Leadership; Mentors; Multi-Institutional Clinical Trial; National Heart, Lung, and Blood Institute; Observational Study; Participant; Pediatric Hospitals; Pediatric Research; Pediatric cardiology; Philadelphia; Registries; Research; Research Activity; Resources; Site; Time; congenital heart disorder; innovation; patient population; programs; prospective; recruit; response; success

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.

项目摘要 先天性心脏畸形和心脏病都会影响成千上万的儿童 年。 NHLBI于2001年将PHN建立为研究企业，现在已经在第三次 赠款周期。 PHN为小儿多中心研究建立了最佳实践 心脏病学，已经完成了14项研究，其中4项正在进行，另外3个接近发射。 始终有多个临床试验和研究。除了表演 观察性研究和临床试验，PHN支持护士，卫生服务和 质量改进研究并监督强大的临床研究指导计划。 该提议的目的是介绍费城儿童医院的能力 （CHOP）参加PHN的核心临床研究中心的赠款周期 从2017财政年度开始。 Chop及其心脏中心一直处于先天性的最前沿，并获得了心脏 研究与创新数十年。自从PHN的核心地点一直是PHN的核心地点 开始。我们是参加每项PHN研究的为数不多的核心站点之一 日期。几乎无一例外地，CHOP是最高的或最重要的招聘人员之一。我们的 大量受试者在成功完成许多方面发挥了作用 PHN项目。在当前的赠款周期中，CHOP负责招募346（18％） 1949年，前瞻性地参与了PHN研究。此提交的PD/PI具有 自PHN成立以来，所有人都是活跃的参与者。他们目前是PD/PI团队 切碎并开发了一个高度有条理的基础设施，并进行了彻底的监督 多个PHN研究。这些功能使CHOP成为成功的组成部分 迄今为止的PHN，将来会继续这样做。其中一些资源包括： 可靠的记录有效，有效地管理所有管理的能力 活动，包括领导多中心临床试验。 经过验证的最佳进行和支持PHN活动和研究的能力。 可用于潜在研究的大量且多样化的患者人群。 有能力识别，注册和保留大量参与者参加临床试验。 具有与其他各种心血管数据库相互作用的经过验证的能力 登记处。 一组广泛的心脏和非心脏临床和研究计划可以 杠杆作用以帮助未来的PHN研究活动。