title: Reporting on data monitoring committees in neonatal randomised controlled trials is inconsistent.
abstract: OBJECTIVE
  To evaluate the reported use of data monitoring committees (DMCs), the frequency of interim analysis, prespecified stopping rules and early trial termination in neonatal randomised controlled trials (RCTs).
  
  
  METHODS
  We reviewed neonatal RCTs published in four high-impact general medical journals, specifically looking at safety issues including documented involvement of a DMC, stated interim analysis, stopping rules and early trial termination. We searched all journal issues over an 11-year period (2003-2013) and recorded predefined parameters on each item for RCTs meeting inclusion criteria.
  
  
  RESULTS
  Seventy neonatal trials were identified in four general medical journals: Lancet, New England Journal of Medicine (NEJM), British Medical Journal and Journal of American Medical Association. A total of 43 (61.4%) studies reported the presence of a DMC, 36 (51.4%) explicitly mentioned interim analysis, stopping rules were reported in 15 (21.4%) RCTs and seven (10%) trials were terminated early. The NEJM most frequently reported these parameters compared to the other three journals reviewed.
  
  
  CONCLUSIONS
  While the majority of neonatal RCTs report on DMC involvement and interim analysis, there is still scope for improvement. Clear documentation of safety-related issues should be a central component of reporting in neonatal trials involving newborn infants.
authors.affiliation: Coombe Women and Infants University Hospital, Dublin 8, Ireland.
authors.forename: L M
authors.initials: LM
authors.lastname: Perrem
authors.affiliation: Department of Paediatrics and Child Health, Neonatal Intensive Care Unit, Cork, Ireland.
authors.forename: S
authors.initials: S
authors.lastname: Gosling
authors.affiliation: Department of Paediatrics and Child Health, Neonatal Intensive Care Unit, Cork, Ireland.
authors.forename: I
authors.initials: I
authors.lastname: Ravikumar
authors.affiliation: Department of Epidemiology and Public Health, University College Cork, Cork, Ireland.|Irish Centre for Fetal and Neonatal Translational Research (INFANT), University College Cork, Cork, Ireland.
authors.forename: A S
authors.initials: AS
authors.lastname: Khashan
authors.affiliation: Coombe Women and Infants University Hospital, Dublin 8, Ireland.
authors.forename: J
authors.initials: J
authors.lastname: Miletin
authors.affiliation: Department of Paediatrics and Child Health, Neonatal Intensive Care Unit, Cork, Ireland.
authors.forename: C A
authors.initials: CA
authors.lastname: Ryan
authors.affiliation: Department of Paediatrics and Child Health, Neonatal Intensive Care Unit, Cork, Ireland.|Irish Centre for Fetal and Neonatal Translational Research (INFANT), University College Cork, Cork, Ireland.
authors.forename: E
authors.initials: E
authors.lastname: Dempsey
mesh_terms: D015706:Bibliometrics; D026661:Clinical Trials Data Monitoring Committees / Q000706:statistics & numerical data*; D057239:Early Termination of Clinical Trials / Q000592:standards*; D006801:Humans; D007231:Infant, Newborn; D061214:Patient Safety / Q000592:standards; D010506:Periodicals as Topic / Q000706:statistics & numerical data; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards* / Q000706:statistics & numerical data; D012107:Research Design / Q000592:standards / Q000706:statistics & numerical data*
keywords: Clinical trials; DMCs; Data monitoring committees; Interim analysis; Neonatal; RCTs; Randomised controlled trials; Stopping rules