Paediatric cardiovascular clinical trials: an analysis of and the Food and Drug Administration Pediatric Drug Labeling Database.


Conference Paper

Recent regulatory initiatives in the United States of America and Europe have transformed the paediatric clinical trials landscape by significantly increasing capital investment and paediatric trial volume. The purpose of this manuscript was to review the impact of these initiatives on the paediatric cardiovascular trials landscape when compared with other paediatric sub-specialties. We also evaluate factors that may have contributed to the success or failure of recent major paediatric cardiovascular trials so as to inform the optimal design and conduct of future trials in the field.

Full Text

Duke Authors

Cited Authors

  • Hill, KD; Henderson, HT; Hornik, CP; Li, JS

Published Date

  • August 2015

Published In

Volume / Issue

  • 25 Suppl 2 /

Start / End Page

  • 172 - 180

PubMed ID

  • 26377725

Pubmed Central ID

  • 26377725

Electronic International Standard Serial Number (EISSN)

  • 1467-1107

Digital Object Identifier (DOI)

  • 10.1017/S1047951115000980

Conference Location

  • England