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Sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the Pediatric Trials Network (PTN) is an alliance of clinical research sites located around the United States that are cooperating in the design and conduct of pediatric clinical trials to improve health care for the youngest patients.

Children are not simply "little adults" who respond to drugs according to scale. Rather, developing organs and changes in metabolism throughout infancy and childhood affect how drugs are processed by immature or maturing bodies. Thus, special care must be taken in tailoring the use of medicines in this unique and vulnerable population. Unfortunately, only a small percentage of drugs and devices approved by the Food and Drug Administration are actually 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 troubling information 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, data collected from PTN trials will help regulators to revise drug labels for safer and more effective use in infants and children.