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Review
. 2015 Aug;25 Suppl 2(0 2):172-80.
doi: 10.1017/S1047951115000980.

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

Kevin D Hill  1 , Heather T Henderson  1 , Christoph P Hornik  1 , Jennifer S Li  1
Affiliations
Review

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

Kevin D Hill et al. Cardiol Young. 2015 Aug.

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.

Keywords: Pediatric cardiovascular trials; heart failure; pediatric exclusivity.

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Figures

Figure 1
Figure 1
Time line depicting recent regulatory initiatives to encourage paediatric drug study in the United States and Europe
Figure 2
Figure 2
Clinical trials registered on ClinicalTrials.gov and associated milestones
Figure 3
Figure 3
Pediatric trials registered on ClinicalTrials.gov (09/2005–10/2010). AI = allergy/immunology, GI = gastroenterology, ID = infectious diseases
Figure 4
Figure 4. Pediatric cardiovascular trial focus and funding sources
NIH = National Institutes of Health, PDA = patent ductus arteriosus, CPR = cardiopulmonary resuscitation
See this image and copyright information in PMC

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