PMID- 12921469
OWN - NLM
STAT- MEDLINE
DCOM- 20031219
LR  - 20131121
IS  - 0890-8567 (Print)
IS  - 0890-8567 (Linking)
VI  - 42
IP  - 6
DP  - 2003 Jun
TI  - Review of safety assessment methods used in pediatric psychopharmacology.
PG  - 627-33
AB  - 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.
FAU - Greenhill, Laurence L
AU  - Greenhill LL
AD  - New York State Psychiatric Institute/Columbia University, New York 10032, USA. 
      LarryLGreenhill@cs.com
FAU - Vitiello, Benedetto
AU  - Vitiello B
FAU - Riddle, Mark A
AU  - Riddle MA
FAU - Fisher, Prudence
AU  - Fisher P
FAU - Shockey, Erin
AU  - Shockey E
FAU - March, John S
AU  - March JS
FAU - Levine, Jerome
AU  - Levine J
FAU - Fried, Jane
AU  - Fried J
FAU - Abikoff, Howard
AU  - Abikoff H
FAU - Zito, Julie M
AU  - Zito JM
FAU - McCracken, James T
AU  - McCracken JT
FAU - Findling, Robert L
AU  - Findling RL
FAU - Robinson, James
AU  - Robinson J
FAU - Cooper, Thomas B
AU  - Cooper TB
FAU - Davies, Mark
AU  - Davies M
FAU - Varipatis, Elena
AU  - Varipatis E
FAU - Labellarte, Michael J
AU  - Labellarte MJ
FAU - Scahill, Lawrence
AU  - Scahill L
FAU - Walkup, John T
AU  - Walkup JT
FAU - Capasso, Lisa
AU  - Capasso L
FAU - Rosengarten, Jennifer
AU  - Rosengarten J
LA  - eng
GR  - N01MH60005/MH/NIMH NIH HHS/United States
GR  - N01MH60016/MH/NIMH NIH HHS/United States
PT  - Journal Article
PT  - Research Support, U.S. Gov't, P.H.S.
PT  - Review
PL  - United States
TA  - J Am Acad Child Adolesc Psychiatry
JT  - Journal of the American Academy of Child and Adolescent Psychiatry
JID - 8704565
RN  - 0 (Psychotropic Drugs)
SB  - IM
MH  - Adolescent
MH  - Adverse Drug Reaction Reporting Systems
MH  - Child
MH  - Child, Preschool
MH  - *Clinical Trials as Topic/methods
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Female
MH  - Humans
MH  - Male
MH  - *Pediatrics
MH  - *Psychopharmacology
MH  - Psychotropic Drugs/*adverse effects
MH  - Quality Assurance, Health Care/methods
MH  - Safety
RF  - 36
EDAT- 2003/08/19 05:00
MHDA- 2003/12/20 05:00
CRDT- 2003/08/19 05:00
PHST- 2003/08/19 05:00 [pubmed]
PHST- 2003/12/20 05:00 [medline]
PHST- 2003/08/19 05:00 [entrez]
AID - S0890-8567(09)61150-3 [pii]
AID - 10.1097/01.CHI.0000046841.56865.37 [doi]
PST - ppublish
SO  - J Am Acad Child Adolesc Psychiatry. 2003 Jun;42(6):627-33. doi: 
      10.1097/01.CHI.0000046841.56865.37.