Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database.
Publication
, Conference
Hill, KD; Henderson, HT; Hornik, CP; Li, JS
Published in: Cardiol Young
August 2015
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.
Duke Scholars
Published In
Cardiol Young
DOI
EISSN
1467-1107
Publication Date
August 2015
Volume
25 Suppl 2
Issue
0 2
Start / End Page
172 / 180
Location
England
Related Subject Headings
- United States Food and Drug Administration
- United States
- Pediatrics
- Humans
- Europe
- Drug Labeling
- Databases, Factual
- Clinical Trials as Topic
- Cardiovascular System & Hematology
- Cardiovascular Diseases
Citation
APA
Chicago
ICMJE
MLA
NLM
Hill, K. D., Henderson, H. T., Hornik, C. P., & Li, J. S. (2015). Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database. In Cardiol Young (Vol. 25 Suppl 2, pp. 172–180). England. https://doi.org/10.1017/S1047951115000980
Hill, Kevin D., Heather T. Henderson, Christoph P. Hornik, and Jennifer S. Li. “Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database.” In Cardiol Young, 25 Suppl 2:172–80, 2015. https://doi.org/10.1017/S1047951115000980.
Hill KD, Henderson HT, Hornik CP, Li JS. Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database. In: Cardiol Young. 2015. p. 172–80.
Hill, Kevin D., et al. “Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database.” Cardiol Young, vol. 25 Suppl 2, no. 0 2, 2015, pp. 172–80. Pubmed, doi:10.1017/S1047951115000980.
Hill KD, Henderson HT, Hornik CP, Li JS. Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database. Cardiol Young. 2015. p. 172–180.
Published In
Cardiol Young
DOI
EISSN
1467-1107
Publication Date
August 2015
Volume
25 Suppl 2
Issue
0 2
Start / End Page
172 / 180
Location
England
Related Subject Headings
- United States Food and Drug Administration
- United States
- Pediatrics
- Humans
- Europe
- Drug Labeling
- Databases, Factual
- Clinical Trials as Topic
- Cardiovascular System & Hematology
- Cardiovascular Diseases