title: How can we improve the assessment of safety in child and adolescent psychopharmacology?
abstract: OBJECTIVE
  To identify approaches to improving methods for assessing tolerability and safety of psychotropic medications in children and adolescents.
  
  
  METHODS
  Strengths and limitations of current methodology were reviewed and possible alternatives examined.
  
  
  RESULTS
  Research on the validity of safety evaluation has been extremely limited. No evidence-based "gold standard" exists. Clinical trials remain the best design to establish causality, but sample size limitations prevent the detection of infrequent, though serious, adverse events. Other designs, such as cohort and case-control studies, and approaches, such as mining of large databases, must be considered.
  
  
  CONCLUSIONS
  The current lack of methodological standardization across studies prevents generalizations and meta-analyses. Because the issues relevant to drug safety are diverse, a variety of methodological approaches and instruments are needed. It is, however, possible to adopt standard basic definitions of adverse events, degree of severity, ascertainment methods, and recording procedures, as a common "core," to which more specific assessment instruments can be added. Systematic empirical testing and validation of safety methodology is needed.
authors.affiliation: Division of Services and Intervention Research, NIMH, Bethesda, MD 20982-9633, USA. bvitiell@nih.gov
authors.forename: Benedetto
authors.initials: B
authors.lastname: Vitiello
authors.forename: Mark A
authors.initials: MA
authors.lastname: Riddle
authors.forename: Laurence L
authors.initials: LL
authors.lastname: Greenhill
authors.forename: John S
authors.initials: JS
authors.lastname: March
authors.forename: Jerome
authors.initials: J
authors.lastname: Levine
authors.forename: Russell J
authors.initials: RJ
authors.lastname: Schachar
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: John T
authors.initials: JT
authors.lastname: Walkup
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: Lisa
authors.initials: L
authors.lastname: Capasso
mesh_terms: D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D008297:Male; D011600:Psychopharmacology; D011619:Psychotropic Drugs / Q000009:adverse effects; D016032:Randomized Controlled Trials as Topic / Q000009:adverse effects
chemical_list: D011619:Psychotropic Drugs