Current Paediatrics
Volume 14, Issue 6 , Pages 519-524, November 2004

The randomized controlled trial

  • David Field

      Affiliations

    • Professor of Neonatal Medicine, Robert Kilpatrick Clinical Sciences Building, University of Leicester, Leicester LE2 7LX, UK
    • Corresponding Author InformationCorresponding author. Tel.: +44-116-258-7707; fax: +44-116-258-5503.
  • ,
  • Diana Elbourne

      Affiliations

    • Professor of Health Care Evaluation, Medical Statistics Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London WCIE 7HT, UK

Summary 

In an era in which all aspects of medicine are being driven by evidence, one consequence has been an increased use of randomized controlled trials. This is not surprising as they represent the most rigorous method of assessment as, by their very nature, they eliminate much of the potential bias that makes other means of comparing ‘treatments’ less reliable. In order to produce clear evidence, however, any trial must be well constructed and carried out. Achieving this requires careful planning, and in this article we hope to cover the important issues that must be considered in relation to any randomized controlled trial.

KEYWORDS: Randomized controlled trial, Children, Randomization, Ethics, Equipoise

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PII: S0957-5839(04)00089-2

doi:10.1016/j.cupe.2004.07.005

Current Paediatrics
Volume 14, Issue 6 , Pages 519-524, November 2004