NICHD HUMAN BIOSPECIMEN REPOSITORY- REPOSITORY SERVICES FOR THE BEST PHARMACEUTICALS FOR CHILDREN ACT (BPCA) AND PEDIATRIC TRIALS NETWORK (PTN)

Fisher Bioservices, Inc., Rockville MD

Investigators

Abstract

Children have been termed therapeutic orphans due to the lack of adequate dosing information, age appropriate formulations, and efficacy and safety information regarding prescribed drugs. The majority of drugs are still used in children off label. To improve knowledge in this field, Congress enacted The Best Pharmaceuticals for Children Act (BPCA) in 2002, BPCA was reauthorized in 2007 and 2012. The NICHD has the primary responsibility to administer, contract, and monitor studies that develop data for potential modification to will benefit children. Through these studies, a large number of biospecimens are generated. It is anticipated that samples in long term storage will be shared for secondary research. The Pediatric Trials Network is an NICHD-funded Network that conducts clinical trials aimed at addressing goals of the BPCA. This network generates are biospecimens from children that are invaluable for advancing understanding of the effect of pharmaceuticals in children.