Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations

Robert E. Shaddy, Scott C. Denne

Research output: Contribution to journalArticle

103 Scopus citations

Abstract

The proper ethical conduct of studies to evaluate drugs in children is of paramount importance to all those involved in these types of studies. This report is an updated revision to the previously published guidelines from the American Academy of Pediatrics in 1995. Since the previous publication, there have been great strides made in the science and ethics of studying drugs in children. There have also been numerous legislative and regulatory advancements that have promoted the study of drugs in children while simultaneously allowing for the protection of this particularly vulnerable group. This report summarizes these changes and advances and provides a framework from which to guide and monitor the ethical conduct of studies to evaluate drugs in children.

Original languageEnglish (US)
Pages (from-to)850-860
Number of pages11
JournalPediatrics
Volume125
Issue number4
DOIs
StatePublished - Apr 1 2010
Externally publishedYes

Keywords

  • Children
  • Drugs
  • Ethics

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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