This application describes the role of New England Research Institutes (NERI) as the proposed Data Coordinating Center for continuation of the Pediatric Heart Disease Clinical Research Network (PHN).
The specific aim of the PHN 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. NERI has served as the PHN Data Coordinating Center since the inception of the PHN and has contributed to the scientific accomplishments of the network as well as developed and implemented administrative, data management statistical, and technical processes for the conduct of this network, which currently includes 7 clinical centers and 7 auxiliary centers. As the PHN DCC, NERI will continue to coordinate the activities of all PHN committees, maintain and enhance secure network and public websites, provide statistical expertise for study design and data analysis (including clinical, surrogate, and cost outcomes), monitor patient safety and oversee regulatory requirements and submit regulatory/safety reports as needed. NERI will also enhance the its proprietary Web-based data management system, ADEPT (Advanced Data Entry and Protocol Tracking), to accommodate new studies, execute procedures for the selection and implementation of multiple core laboratories for network studies, and practice good quality assurance technique via central training of clinic staff, site visits, and specialized laboratory protocols. In the renewal period, NERI will also utilize its existing infrastructure due its experience with several NIH networks to administer patient care funds to clinical centers and disseminate the results of PHN research. NERI will build upon the systems already in place as the PHN DCC and utilize its experienced Administrative, Data Management &Programming, Statistical, and Clinical/Regulatory Teams to complete 3 ongoing PHN studies and initiate at least 3 new studies in the new grant period. The Pediatric Heart Disease Clinical Research Network will have a direct impact on advances in the field of pediatric cardiology by providing the resources to conduct studies in a multi-center fashion, which will provide sufficient patients to evaluate important hypotheses regarding management and therapy in this patient population and prompt dissemination of these findings to the pediatric and cardiology communities.
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