title: Review of safety assessment methods used in pediatric psychopharmacology.
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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: New York State Psychiatric Institute/Columbia University, New York 10032, USA. LarryLGreenhill@cs.com
authors.forename: Laurence L
authors.initials: LL
authors.lastname: Greenhill
authors.forename: Benedetto
authors.initials: B
authors.lastname: Vitiello
authors.forename: Mark A
authors.initials: MA
authors.lastname: Riddle
authors.forename: Prudence
authors.initials: P
authors.lastname: Fisher
authors.forename: Erin
authors.initials: E
authors.lastname: Shockey
authors.forename: John S
authors.initials: JS
authors.lastname: March
authors.forename: Jerome
authors.initials: J
authors.lastname: Levine
authors.forename: Jane
authors.initials: J
authors.lastname: Fried
authors.forename: Howard
authors.initials: H
authors.lastname: Abikoff
authors.forename: Julie M
authors.initials: JM
authors.lastname: Zito
authors.forename: James T
authors.initials: JT
authors.lastname: McCracken
authors.forename: Robert L
authors.initials: RL
authors.lastname: Findling
authors.forename: James
authors.initials: J
authors.lastname: Robinson
authors.forename: Thomas B
authors.initials: TB
authors.lastname: Cooper
authors.forename: Mark
authors.initials: M
authors.lastname: Davies
authors.forename: Elena
authors.initials: E
authors.lastname: Varipatis
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Labellarte
authors.forename: Lawrence
authors.initials: L
authors.lastname: Scahill
authors.forename: John T
authors.initials: JT
authors.lastname: Walkup
authors.forename: Lisa
authors.initials: L
authors.lastname: Capasso
authors.forename: Jennifer
authors.initials: J
authors.lastname: Rosengarten
mesh_terms: D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D008297:Male; D010372:Pediatrics; D011600:Psychopharmacology; D011619:Psychotropic Drugs / Q000009:adverse effects*; D011785:Quality Assurance, Health Care / Q000379:methods; D012449:Safety
chemical_list: D011619:Psychotropic Drugs