Introduction: US legislation, supported by strengthened ethical fiameworks and improved lowed. Few trials specifically studied neonates, infants, and toddm. trial design, has pnhced significant increases in the number of pediatric clinical trials. This has global implications. Method: We reviewed all submissions of pediatric data received by the US FDA fiom 2002 to 2007 in response to new FDA pediatric initiatives. Results: Although 54% of the trials were multinational, the US dominated as a trial location. IIe European Union and k t i n America fd-Conclusion: Although most pediatric drug programs arcglobal, the United States remains the dominant location forpediatric trials. This distribution differs for adult trials. The balance may change in the future. E U and FDA rcgulators should continue to discuss coordinated approaches to minimize unnecessary pediatric tials and to optimize trial design, safety, and conduct so that the limited pediatric populations available are enrdled only in ethically implemented, scientifidy important trials.
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