title: Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database.
abstract: 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.
authors.affiliation: 1Duke University Medical Center,Durham,North Carolina,United States of America.
authors.forename: Kevin D
authors.initials: KD
authors.lastname: Hill
authors.affiliation: 1Duke University Medical Center,Durham,North Carolina,United States of America.
authors.forename: Heather T
authors.initials: HT
authors.lastname: Henderson
authors.affiliation: 1Duke University Medical Center,Durham,North Carolina,United States of America.
authors.forename: Christoph P
authors.initials: CP
authors.lastname: Hornik
authors.affiliation: 1Duke University Medical Center,Durham,North Carolina,United States of America.
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Li
mesh_terms: D002318:Cardiovascular Diseases / Q000145:classification*; D002986:Clinical Trials as Topic / Q000592:standards*; D016208:Databases, Factual / Q000592:standards*; D004348:Drug Labeling; D005060:Europe; D006801:Humans; D010372:Pediatrics; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*
keywords: Pediatric cardiovascular trials; heart failure; pediatric exclusivity