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

Published online by Cambridge University Press:  17 September 2015

Kevin D. Hill ,
Heather T. Henderson ,
Christoph P. Hornik  and
Jennifer S. Li
Kevin D. Hill*
Affiliation:
Duke University Medical Center, Durham, North Carolina, United States of America Duke Clinical Research Institute, Durham, North Carolina, United States of America
Heather T. Henderson
Affiliation:
Duke University Medical Center, Durham, North Carolina, United States of America
Christoph P. Hornik
Affiliation:
Duke University Medical Center, Durham, North Carolina, United States of America Duke Clinical Research Institute, Durham, North Carolina, United States of America
Jennifer S. Li
Affiliation:
Duke University Medical Center, Durham, North Carolina, United States of America Duke Clinical Research Institute, Durham, North Carolina, United States of America
*
Correspondence to: K. D. Hill, MD MSCI, DUMC, Department of Pediatrics, Division of Pediatric Cardiology, Duke University Medical Center and the Duke Clinical Research Institute, Durham, NC 27105, United States of America. Tel: +919 668 8305; Fax: +919 681 8927; E-mail: kevin.hill@duke.edu
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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 trialspediatric exclusivityheart failure
Type
Original Articles
Information
Cardiology in the Young , Volume 25 , Supplement S2: Special Supplement of Cardiology in the Young: Proceedings of the 2015 International Paediatric Heart Failure Summit of Johns Hopkins All Children's Heart Institute , August 2015 , pp. 172 - 180
Copyright
© Cambridge University Press 2015 

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Footnotes

*

Presented at Johns Hopkins All Children’s Heart Institute, International Pediatric Heart Failure Summit, Saint Petersburg, Florida, United States of America, 4–5 February, 2015.

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