title: The globalization of pediatric clinical trials.
abstract: OBJECTIVE
  To examine the characteristics of pediatric trials conducted under US legislation and to compare results with data from 2002 to 2007.
  
  
  METHODS
  We reviewed all pediatric trials provided to the US Food and Drug Administration in submissions that were approved between September 28, 2007 and December 21, 2010. We extracted data for each trial including age range, therapeutic indication, design, duration, and patient and center enrollment by location.
  
  
  RESULTS
  Overall 346 studies on 113 drugs and biologicals enrolled 55 819 pediatric patients. The United States participated in 86% of the studies, providing 71% of the centers and 74% of the patients. Corresponding percentages for non-US countries were 43%, 29%, and 26% respectively. Developing or transition countries participated in 22% of the studies, providing 12% of the centers and 10% of the patients; our earlier analysis found corresponding percentages of 38%, 12%, and 23%. The most common therapeutic areas studied in the latter countries were infectious, neurologic, and pulmonary diseases. Seventy-eight vaccine studies enrolled 147 692 patients. The United States participated in 40% of the studies, providing 39% of the centers and 22% of the patients. Corresponding percentages for non-US countries were 74%, 61%, and 78% respectively. Developing or transition countries participated in 27% of the studies, providing 15% of the centers and 52% of the patients.
  
  
  CONCLUSIONS
  The United States remains an important location for pediatric trials. Developing country involvement in pediatric drug development is not increasing, although these countries participate significantly in vaccine trials.
authors.affiliation: Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA. julia.dunne@mhra.gsi.gov.uk
authors.forename: Julia
authors.initials: J
authors.lastname: Dunne
authors.forename: M Dianne
authors.initials: MD
authors.lastname: Murphy
authors.forename: William J
authors.initials: WJ
authors.lastname: Rodriguez
mesh_terms: D001688:Biological Products / Q000627:therapeutic use; D002648:Child; D002986:Clinical Trials as Topic / Q000639:trends*; D015331:Cohort Studies; D003431:Cross-Cultural Comparison; D003906:Developing Countries; D005544:Forecasting; D006801:Humans; D038622:Internationality; D010372:Pediatrics / Q000639:trends*; D055553:Prescription Drugs / Q000627:therapeutic use; D014481:United States; D014486:United States Food and Drug Administration; D014612:Vaccines / Q000627:therapeutic use
chemical_list: D001688:Biological Products; D055553:Prescription Drugs; D014612:Vaccines