The NICHD, as delegated by the NIH, is responsible for implementing the Congressionally-mandated Best Pharmaceuticals for Children Act of 2002, as reauthorized in 2007. The NICHD is responsible for the performance of clinical trials of priority, ?off patent? drugs that are used in children but that lack sufficient pediatric labeling. NICHD responsibility includes administrative activities as well as support, and coordinating support and participation of other ICs in BPCA activities.. In 2003, NICHD awarded a five (5) year contract to Premier Research of Philadelphia PA to provide services for a BPCA Data Coordinating Center (DCC). The purpose of the contract is to establish and support an infrastructure for the coordination of the BPCA pediatric clinical trials. The function of this DCC is to provide regulatory, technical (including statistical and information technology), administrative and logistical support to maintain, coordinate and manage a multi-site network of clinical centers which will conduct pharmacology studies in children. Throughout the years. several practical problems have discouraged drug testing in children. These inlclude the lack of a suitable infrastructure to conduct pediatric pharmacology research;the inforseeable nature of some clinical responses in immature individuals;the possibility of unanticipated adverse reactions; the threat of effects on growth, development or health long after the drug's administration. There is a significant unmet need for pediatric therapeutic and diagnostic device development. In spite of these challenges, the NICHD is aware of the critical need to establish an environment in which safe and effective pediatric clinical and device trial activities can quickly be initiated and managed, which is the objective of the project.

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