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Statements

Subject Item
dbr:Duke_University_School_of_Medicine
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dbr:Pediatric_Trials_Network
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dbr:Food_and_Drug_Administration_Amendments_Act_of_2007
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Pediatric Trials Network
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The Pediatric Trials Network (PTN) is a consortium of clinical research sites located around the United States that are cooperating in the design and conduct of clinical trials to improve health care for young patients. The network is sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). A map of sites currently participating in PTN trials may be viewed on the network's website [1].
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The Pediatric Trials Network (PTN) is a consortium of clinical research sites located around the United States that are cooperating in the design and conduct of clinical trials to improve health care for young patients. The network is sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The work of the PTN addresses a critical lack of information regarding the impact of therapeutic agents on infants and children. Developing organs and changes in metabolism throughout infancy and childhood affect how drugs are processed by immature or maturing bodies; thus, age-dependent adjustments in doses are required to ensure that such therapies are used safely and effectively. Unfortunately, only a small percentage of drugs and devices approved by the Food and Drug Administration (FDA) have actually been studied in children and are labeled for pediatric use. Pediatricians, consequently, are often forced to prescribe medical therapies "off-label," or according to their best guess based on adult studies. To fill this knowledge gap, the PTN is studying the formulation, dosing, efficacy, and safety of drugs, as well as the development of medical devices, used in pediatric patients. In keeping with the goals of the Best Pharmaceuticals for Children Act (BPCA), data collected from PTN trials are helping regulators to revise FDA labels for safer and more effective use in infants and children. A map of sites currently participating in PTN trials may be viewed on the network's website [1].
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