Globalization Facilitates Pediatric Drug Development in the 21 st Century
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Julio Dunne, MA, MD Office of Pediatric Therapeutics, Food and Drug Administration. Silver Spring. Maryland
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Globalization Facilitates Pediatric Drug Development in the 21st Century
Lolo Morgaryaats, PhormD Scientific Centre of Drug and Medical Technology Expertise. Yerevan. Republic of Armenia
M. Dionne Murphy, MD Office of Pediatric Therapeutics. Food a n d Drug Administration. Silver Spring. Maryland
Ann M. Myers, RPh, MPH Office of Pediatric Therapeutics, Food and Drug Administration. Silver Spring, Maryland
Debbie Avont, RPh Office of Pediatric Therapeutics. Food and Drug Administration. Silver Spring, Maryland
Introduction: US legislation, supported by strengthened ethical fiameworks and improved trial design, has pnhced significantincreases 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-
lowed. Few trials specifically studied neonates, infants, and toddm. Conclusion: Although most pediatric drug programs arcglobal, the United States remains the dominant location forpediatric trials. This distribution differsfor adult trials. The balance may change in the future. EU 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.
Willion 1. Rodriguez, MD, PhD Office of Pediatric Therapeutics. Food and Drug Administration. Silver Spring, Maryland
Key Words Globalization: Pediatric clinical trial; F D A
Correspondence Address Julia Dunne, Food and Drug Administration. I0903 New Hampshire Ave. Building 32,Room 5 1 5 4 . Silver Spring. MD 20993 (email: julia.dunne@fda. hhs.gov). The views presented in this article d o not necessarily reflect those ofthe Food and Drug Administration.
INTRODUCTION A historical reluctance to study medicines in children has necessitated decades of off-label use for most pediatric prescribing (1-3). Ethical concerns and the difficulties of conducting trials in children fueled the reluctance, which was exacerbated by the lack of sufficient commercial returns for the pharmaceutical industry (4).This unacceptable situation, however, is changing. More robust ethical, regulatory, and legal frameworks exist to ensure the protection of children, who can neither volunteer nor give informed consent to take part in trials (5-7).Furthermore, it is agreed that children are not small adults (8) and pediatric trials are needed to establish the correct dose, efficacy, and safety of a medicine in that population (9.10).Increasing involvement of pediatric expertise has improved the design and conduct of these trials. Finally, important changes in US legislation both provided
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