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.
This application is a response of The Children?s Hospital of Philadelphia (CHOP) to the NHLBI Funding Opportunity Announcement for participation in the Pediatric Heart Network as a Clinical Research Center for the grant cycle beginning in Fiscal year 2017. It presents CHOP?s significant clinical and research resources. It presents CHOP?s significant past contributions and potential future contributions to the PHN.