Review of safety assessment methods used in pediatric psychopharmacology.
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.
Greenhill
Laurence L
LL
New York State Psychiatric Institute/Columbia University, New York 10032, USA. LarryLGreenhill@cs.com
Vitiello
Benedetto
B
Riddle
Mark A
MA
Fisher
Prudence
P
Shockey
Erin
E
March
John S
JS
Levine
Jerome
J
Fried
Jane
J
Abikoff
Howard
H
Zito
Julie M
JM
McCracken
James T
JT
Findling
Robert L
RL
Robinson
James
J
Cooper
Thomas B
TB
Davies
Mark
M
Varipatis
Elena
E
Labellarte
Michael J
MJ
Scahill
Lawrence
L
Walkup
John T
JT
Capasso
Lisa
L
Rosengarten
Jennifer
J
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
D011619:Psychotropic Drugs