Review of safety assessment methods used in pediatric psychopharmacology

Laurence L. Greenhill, Benedetto Vitiello, Mark A. Riddle, Prudence Fisher, Erin Shockey, John S. March, Jerome Levine, Jane Fried, Howard Abikoff, Julie M. Zito, James T. McCracken, Robert L. Findling, James Robinson, Thomas B. Cooper, Mark Davies, Elena Varipatis, Michael J. Labellarte, Lawrence Scahill, John T. Walkup, Lisa CapassoJennifer Rosengarten

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: Elicitation is an essential and critical step in ascertaining adverse events (AEs). This report reviews elicitation methods used in published clinical trials of psychopharmacological agents in children. Method: Pediatric psychopharmacology reports were reviewed for safety methods in the Medline database. Studies were included if they were published 1980 or later, provided data on AEs, and described the ascertainment methodology used for determining them. Results: A review of 196 pediatric psychopharmacology articles depicting safety assessments in clinical studies over the past 22 years revealed that there was no common method used for eliciting or reporting AE data. Conclusion: The current inconsistency in safety data ascertainment is a major limitation that likely impairs the ability to promptly and accurately identify drug-induced AEs. Research on how best to standardize safety methods should be considered a priority in pediatric psychopharmacology.

Original languageEnglish (US)
Pages (from-to)627-633
Number of pages7
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Volume42
Issue number6
DOIs
StatePublished - Jun 2003

Keywords

  • Adverse events
  • Children
  • Drug safety
  • Psychopharmacology
  • Treatment

ASJC Scopus subject areas

  • Developmental and Educational Psychology
  • Psychiatry and Mental health

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