Review of safety assessment methods used in pediatric psychopharmacology.


Journal Article (Review)

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.

Full Text

Cited Authors

  • Greenhill, LL; Vitiello, B; Riddle, MA; Fisher, P; Shockey, E; March, JS; Levine, J; Fried, J; Abikoff, H; Zito, JM; McCracken, JT; Findling, RL; Robinson, J; Cooper, TB; Davies, M; Varipatis, E; Labellarte, MJ; Scahill, L; Walkup, JT; Capasso, L; Rosengarten, J

Published Date

  • June 2003

Published In

Volume / Issue

  • 42 / 6

Start / End Page

  • 627 - 633

PubMed ID

  • 12921469

Pubmed Central ID

  • 12921469

Electronic International Standard Serial Number (EISSN)

  • 1527-5418

International Standard Serial Number (ISSN)

  • 0890-8567

Digital Object Identifier (DOI)

  • 10.1097/01.chi.0000046841.56865.37


  • eng