Abstract
Introduction: US legislation, supported by strengthened ethical frameworks and improved trial design, has produced 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 from 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. The European Union and Latin America followed. Few trials specifically studied neonates, infants, and toddlers.Conclusion: Although most pediatric drug programs are global, the United States remains the dominant location for pediatric trials. This distribution differs for adult trials. The balance may change in the future. EU and FDA regulators should continue to discuss coordinated approaches to minimize unnecessary pediatric trials and to optimize trial design, safety, and conduct so that the limited pediatric populations available are enrolled only in ethically imple...
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