title: Data monitoring committees, interim analysis and early termination in paediatric trials.
abstract: OBJECTIVE
  To evaluate whether paediatric randomized clinical trials (RCTs) adopt recent guidance on Data Monitoring Committees (DMCs), interim analysis and early termination.
  
  
  METHODS
  We reviewed paediatric RCTs that reported on DMCs, interim analysis or early termination, published in eight general medical and paediatric journals (2005-2007). We searched full-text databases for eligible trials and recorded predefined parameters on each item. Reported activities were compared with current scientific guidance.
  
  
  RESULTS
  A total of 110 of 648 paediatric trials (17%) reported on DMC, interim analysis or early stopping. Various approaches for convening a DMC were identified; information on DMC composition and independence was limited. Strict predefined statistical stopping 'rules' were reported in 10 of 23 trials, and interim analyses were more frequently performed on efficacy than on safety outcomes (39/45 vs 27/45). No adjustment for repeated testing was reported in 11 of 33 trials reporting monitoring methods and in 7 of 17 early terminated trials. Validity of results from early stopped trials was threatened by small sample sizes. Incomplete reporting hampered a full analysis.
  
  
  CONCLUSIONS
  Few paediatric trials report on DMCs' roles, interim analysis or early stopping. Heterogeneous practices and apparent shortcomings jeopardize the validity of trial results. Easily accessible guidelines for the design, conduct and reporting of paediatric DMCs are needed.
authors: Departamento da Criança e da Família (Child and Family Department), Hospital de Santa Maria, Centro Hospitalar Lisboa Norte EPE, and Farmacologia Clínica e Terapêutica (Therapeutics and Clinical Pharmacology), Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Lisboa, Portugal. ricardocunhafernandes@clix.pt
authors: Ricardo M
authors: RM
authors: Fernandes
authors: Johanna H
authors: JH
authors: van der Lee
authors: Martin
authors: M
authors: Offringa
mesh_terms: D026661:Clinical Trials Data Monitoring Committees; D003627:Data Interpretation, Statistical; D057239:Early Termination of Clinical Trials / Q000592:standards / Q000706:statistics & numerical data*; D019983:Guideline Adherence / Q000706:statistics & numerical data*; D017408:Guidelines as Topic; D010372:Pediatrics / Q000379:methods*; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design / Q000592:standards