title: Safety in paediatric clinical trials--a 7-year review.
abstract: OBJECTIVE
  The safety of clinical trials in children has not been previously studied. We aimed to identify how safety is monitored and the extent of adverse drug reactions (ADRs).
  
  
  METHODS
  A literature review of the Medline Database for therapeutic clinical trials involving oral and intravenous medicines in children from 1996 to 2002. Papers were read to determine the safety monitoring and the presence of adverse events (AEs) or ADRs.
  
  
  RESULTS
  Seven hundred thirty-nine trials were identified. Thirteen (2%) had safety monitoring committees (SMCs). Five hundred twenty-three (71%) trials reported AEs and 151 (20%) of these trials reported a serious AE. ADRs were present in 270 (36.5%) trials, with 80 (11%) of trials having a moderate or severe ADR. Six clinical trials were terminated early because of significant drug toxicity. All of these had SMCs. There were deaths in 83 (11%) trials. In the majority of trials, mortality was thought to be unrelated to the investigational drug; however, in two trials mortality was higher in the treatment group.
  
  
  CONCLUSIONS
  About 11% of trials have a moderate or severe ADR. All paediatric clinical trials should have a SMC.
authors.affiliation: Academic Division of Child Health, The Medical School, University of Nottingham, Derbyshire Children's Hospital, Uttoxeter Road, Derby DE22 3DT, UK. Helen.sammons@nottingham.ac.uk
authors.forename: H M
authors.initials: HM
authors.lastname: Sammons
authors.forename: C
authors.initials: C
authors.lastname: Gray
authors.forename: H
authors.initials: H
authors.lastname: Hudson
authors.forename: J
authors.initials: J
authors.lastname: Cherrill
authors.forename: I
authors.initials: I
authors.lastname: Choonara
mesh_terms: D002648:Child; D026661:Clinical Trials Data Monitoring Committees; D002986:Clinical Trials as Topic / Q000009:adverse effects / Q000706:statistics & numerical data*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D010372:Pediatrics / Q000592:standards; D012449:Safety