Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database.
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ABSTRACT:
SUBMITTER: Hill KD
PROVIDER: S-EPMC4591024 | biostudies-literature | 2015 Aug
REPOSITORIES: biostudies-literature
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Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database.
Hill Kevin D KD Henderson Heather T HT Hornik Christoph P CP Li Jennifer S JS
Cardiology in the young 20150801
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 cardiovas ...[more]
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