title: Developing methodologies for monitoring long-term safety of psychotropic medications in children: report on the NIMH conference, September 25, 2000.
abstract: OBJECTIVE
  To improve the methods for long-term assessment of drug-associated side effects and advance knowledge of the safety profile of psychotropic medications in children and adolescents.
  
  
  METHODS
  A multidisciplinary, interactive workshop was hosted by the National Institute of Mental Health (NIMH) and the Research Units on Pediatric Psychopharmacology network. Participants were experts in child and adolescent psychiatry, psychopharmacology, pharmacoepidemiology, and statistics from academia, the pharmaceutical industry, the Food and Drug Administration (FDA), and the NIMH. Evaluation of drug safety was examined from five perspectives: research design and methods, industry, regulatory requirements, bioethics, and practice settings. For each of these areas, special emphasis was placed on identifying barriers and generating solutions.
  
  
  RESULTS
  A major obstacle is the lack of standardization of the methods used for collecting safety data. The limitations of both randomized clinical trials and passive postmarketing surveillance in assessing long-term safety were recognized. The need to consider alternative approaches, such as registries and trend analysis of population-based databases, was highlighted. Recommendations were proposed together with possible approaches to implementation.
  
  
  CONCLUSIONS
  A concerted effort by academic researchers, industry, FDA, practitioners, and NIMH is needed to standardize methods and lay the foundations for systematic research on the long-term safety of psychotropic medications in children.
authors.affiliation: New York State Psychiatric Institute, 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: Howard
authors.initials: H
authors.lastname: Abikoff
authors.forename: Jerome
authors.initials: J
authors.lastname: Levine
authors.forename: John S
authors.initials: JS
authors.lastname: March
authors.forename: Mark A
authors.initials: MA
authors.lastname: Riddle
authors.forename: Lisa
authors.initials: L
authors.lastname: Capasso
authors.forename: Thomas B
authors.initials: TB
authors.lastname: Cooper
authors.forename: Mark
authors.initials: M
authors.lastname: Davies
authors.forename: Prudence
authors.initials: P
authors.lastname: Fisher
authors.forename: Robert L
authors.initials: RL
authors.lastname: Findling
authors.forename: Jane
authors.initials: J
authors.lastname: Fried
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Labellarte
authors.forename: James T
authors.initials: JT
authors.lastname: McCracken
authors.forename: Don
authors.initials: D
authors.lastname: McMahon
authors.forename: James
authors.initials: J
authors.lastname: Robinson
authors.forename: Anne
authors.initials: A
authors.lastname: Skrobala
authors.forename: Lawrence
authors.initials: L
authors.lastname: Scahill
authors.forename: Elena
authors.initials: E
authors.lastname: Varipatis
authors.forename: John T
authors.initials: JT
authors.lastname: Walkup
authors.forename: Julie M
authors.initials: JM
authors.lastname: Zito
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000379:methods; D003226:Congresses as Topic; D005260:Female; D006801:Humans; D008134:Long-Term Care; D008297:Male; D009315:National Institute of Mental Health (U.S.); D011600:Psychopharmacology / Q000379:methods*; D011619:Psychotropic Drugs / Q000009:adverse effects; D012107:Research Design; D012449:Safety; D014481:United States
chemical_list: D011619:Psychotropic Drugs