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

Author

Hill KD, Henderson HT, Hornik CP, and Li JS

Subjects
Drug Labeling, Europe, Humans, United States, Cardiovascular Diseases classification, Clinical Trials as Topic standards, Databases, Factual standards, Pediatrics, United States Food and Drug Administration organization & administration
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.

Published
2015
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