We thank Maldonado et al and Dunne et al for their interest in our article.1 Although Maldonado et al at Johnson & Johnson discuss that “only” 11% of the trials we evaluated were conducted solely outside the United States, representing a small proportion of studies, it should be noted that most (65%) of the trials enrolled patients in at least 1 country outside of the United States.1 We appreciate that Johnson & Johnson has policies regarding site selection, transparency, and publication. However, policies such as theirs do not seem to be in place across the board; we have previously shown that fewer than half of the studies conducted under the pediatric exclusivity provision were published in the peer-reviewed literature.2 In addition, in our study we found that 9% of the published studies did not report any information regarding the location or number of sites in which the...
FINANCIAL DISCLOSURE: Dr Pasquali receives research support from the National Heart, Lung, and Blood Institute (grants 1K08HL103631-01 and 1RC1HL099941-01) and the American Heart Association Mid-Atlantic Clinical Research Program; Dr Benjamin receives support from the US government for work in pediatric and neonatal clinical pharmacology (Eunice Kennedy Shriver National Institute of Child Health and Human Development and Food and Drug Administration grants 1R01HD057956-03, 1R01FD003519-02, 1U10-HD45962-05, and 1K24HD058735-02), the nonprofit organization Thrasher Research Foundation for work in neonatal candidiasis (www.thrasherresearch.org), and from industry for neonatal and pediatric drug development (www.dcri.duke.edu/research/coi.jsp), has received support from Johnson and Johnson as a consultant (less than $10 000), and is the principal investigator of the Pediatric Trials Network supported by Eunice Kennedy Shriver National Institute of Child Health and Human Development grant HHSN275201000002I); Dr Smith receives support from the US government for work in neonatal clinical pharmacology (Eunice Kennedy Shriver National Institute of Child Health and Human Development and US Department of Health and Human Services grants 1K23HD060040-01, 1R18AE000028-01, and HHSN275201000002I) and from industry for neonatal and pediatric drug development (www.dcri.duke.edu/research/coi.jsp); and Dr Li receives grant support from Genzyme and Sanofi Aventis and consulting fees/honoraria from Pfizer, Eli Lilly, and PTC Bio. Ms Burstein has indicated she has no financial relationships relevant to this article to disclose.
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Sara K. Pasquali, Danielle S. Burstein, Daniel K. Benjamin, P. Brian Smith, Jennifer S. Li; In Reply. Pediatrics January 2011; 127 (1): e253–e254. 10.1542/peds.2010-3381B
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