title: Children's views on unlicensed/off-label paediatric prescribing and paediatric clinical trials.
abstract: OBJECTIVE
  To explore the views and perspectives of children on the unlicensed/off-label use of medicines in children and on the participation of children in clinical trials.
  
  
  METHODS
  Focus-group discussions, involving school children, were carried out in a range of primary and secondary schools in Northern Ireland. A purposeful sample was chosen to facilitate representation of various socioeconomic groupings.
  
  
  RESULTS
  A total of 123 pupils, aged from 10 to 16 years, from six schools, participated in 16 focus groups. In general, pupils viewed the unlicensed/off-label use of medicines in children as unsafe and unethical and felt it is necessary to test medicines in children to improve the availability of licensed products. The majority felt that older children should be told, and that parents should be told, about the unlicensed/off-label use of medicines in children, yet they recognised some implications of this, such as potential medication non-adherence.
  
  
  CONCLUSIONS
  This is the first study to explore the views of healthy children on unlicensed medicine use in children. Children were able to recognise potential risks associated with the unlicensed use of medicines and felt it is necessary to test and license more medicines in children.
  
  
  CONCLUSIONS
  Health care professionals should consider the views of children in decisions that affect their health.
authors.affiliation: Clinical and Practice Research Group, School of Pharmacy, Medical Biology Centre, Queen's University Belfast, 97 Lisburn Road, BT9 7BL, Belfast, UK.
authors.forename: Tareq
authors.initials: T
authors.lastname: Mukattash
authors.forename: Karen
authors.initials: K
authors.lastname: Trew
authors.forename: Ahmed F
authors.initials: AF
authors.lastname: Hawwa
authors.forename: James C
authors.initials: JC
authors.lastname: McElnay
mesh_terms: D000293:Adolescent; D001294:Attitude to Health; D035843:Biomedical Research / Q000941:ethics; D002648:Child; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000523:psychology; D004348:Drug Labeling; D005260:Female; D017144:Focus Groups; D006801:Humans; D008297:Male; D056687:Off-Label Use / Q000941:ethics*; D010372:Pediatrics; D010818:Practice Patterns, Physicians' / Q000941:ethics*; D013334:Students / Q000523:psychology*