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Pediatric cardiovascular drug trials, lessons learned.

Publication ,  Journal Article
Li, JS; Cohen-Wolkowiez, M; Pasquali, SK
Published in: J Cardiovasc Pharmacol
July 2011

Few drugs have been labeled for pediatric cardiovascular indications, and many children with cardiac disease are prescribed drugs off-label. Recent initiatives have narrowed this gap, and as a result, there are an increasing number of cardiology trials in the pediatric population. Many studies, however, have either failed to show a dose response in children or have not shown efficacy in children when they have established efficacy in adults. Clinical trials are challenging in children; many factors such as lack of development of a liquid formulation, failure to fully incorporate pharmacokinetic information into trial design, poor dose selection, the lack of clinical equipoise, and the use of difficult surrogate and composite primary endpoints have led to the difficulties and failures observed in several pediatric cardiovascular trials. These lessons learned may help to inform future pediatric clinical trial development.

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Published In

J Cardiovasc Pharmacol

DOI

EISSN

1533-4023

Publication Date

July 2011

Volume

58

Issue

1

Start / End Page

4 / 8

Location

United States

Related Subject Headings

  • Humans
  • Dose-Response Relationship, Drug
  • Clinical Trials as Topic
  • Child
  • Cardiovascular System & Hematology
  • Cardiovascular Diseases
  • Cardiovascular Agents
  • Biomarkers
  • Age Factors
  • 3214 Pharmacology and pharmaceutical sciences
 

Citation

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Li, J. S., Cohen-Wolkowiez, M., & Pasquali, S. K. (2011). Pediatric cardiovascular drug trials, lessons learned. J Cardiovasc Pharmacol, 58(1), 4–8. https://doi.org/10.1097/FJC.0b013e31820d1c54
Li, Jennifer S., Michael Cohen-Wolkowiez, and Sara K. Pasquali. “Pediatric cardiovascular drug trials, lessons learned.J Cardiovasc Pharmacol 58, no. 1 (July 2011): 4–8. https://doi.org/10.1097/FJC.0b013e31820d1c54.
Li JS, Cohen-Wolkowiez M, Pasquali SK. Pediatric cardiovascular drug trials, lessons learned. J Cardiovasc Pharmacol. 2011 Jul;58(1):4–8.
Li, Jennifer S., et al. “Pediatric cardiovascular drug trials, lessons learned.J Cardiovasc Pharmacol, vol. 58, no. 1, July 2011, pp. 4–8. Pubmed, doi:10.1097/FJC.0b013e31820d1c54.
Li JS, Cohen-Wolkowiez M, Pasquali SK. Pediatric cardiovascular drug trials, lessons learned. J Cardiovasc Pharmacol. 2011 Jul;58(1):4–8.

Published In

J Cardiovasc Pharmacol

DOI

EISSN

1533-4023

Publication Date

July 2011

Volume

58

Issue

1

Start / End Page

4 / 8

Location

United States

Related Subject Headings

  • Humans
  • Dose-Response Relationship, Drug
  • Clinical Trials as Topic
  • Child
  • Cardiovascular System & Hematology
  • Cardiovascular Diseases
  • Cardiovascular Agents
  • Biomarkers
  • Age Factors
  • 3214 Pharmacology and pharmaceutical sciences