How can we improve the assessment of safety in child and adolescent psychopharmacology?

Benedetto Vitiello*, Mark A. Riddle, Laurence L. Greenhill, John S. March, Jerome Levine, Russell J. Schachar, Howard Abikoff, Julie M. Zito, James T. McCracken, John T. Walkup, Robert L. Findling, James Robinson, Thomas B. Cooper, Mark Davies, Elena Varipatis, Michael J. Labellarte, Lawrence Scahill, Lisa Capasso

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

49 Scopus citations

Abstract

Objective: To identify approaches to improving methods for assessing tolerability and safety of psychotropic medications in children and adolescents. Method: 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.

Original languageEnglish (US)
Pages (from-to)634-641
Number of pages8
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Volume42
Issue number6
DOIs
StatePublished - Jun 2003

Keywords

  • Adverse events
  • Children
  • Psychopharmacology
  • Treatment

ASJC Scopus subject areas

  • Developmental and Educational Psychology
  • Psychiatry and Mental health

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