Globalized Pediatric Research

Abstract

Pasquali et al1 have provided important data regarding pediatric studies conducted under pediatric exclusivity provisions of US laws that have been highly successful in incentivizing the generation of much needed information regarding pediatric usage of drugs.2 However, the authors raised many theoretical concerns about global pediatric trials while providing few data to support such concerns. Our own experience questions whether an examination of all of the data should be undertaken before reaching the broad conclusions presented in the article. Only 11% of the trials reviewed by Pasquali et al were conducted solely outside the United States, a far smaller proportion than the “approximately one-third” in the study of adult trials by large US pharmaceutical firms reported by Glickman et al,3 notwithstanding the assertion by Pasquali et al that their findings were similar to those of Glickman et al. Although data regarding indication were not presented for this 11%, Pasquali et al noted that several overseas trials in their study were performed …