Seven myths of randomisation in clinical trials

Stephen Senn*

*Corresponding author for this work

Research output: Contribution to journalArticleResearchpeer-review

88 Citations (Scopus)

Abstract

I consider seven misunderstandings that may be encountered about the nature, purpose and properties of randomisation in clinical trials. Some concern the practical realities of clinical research on patients. Others are to do with the value and purpose of balance. Still others are to do with a confusion about the role of conditioning in valid statistical inference. I consider a simple game of chance involving two dice to illustrate some points about inference and then consider the seven misunderstandings in turn. I conclude that although one should not make a fetish of randomisation, when proposing alternatives to randomisation in clinical trials, one should be very careful to be precise about the exact nature of the alternative being considered if one is to avoid the danger of underestimating the advantages that randomisation can offer.

Original languageEnglish
Pages (from-to)1439-1450
Number of pages12
JournalStatistics in Medicine
Volume32
Issue number9
DOIs
Publication statusPublished - 30 Apr 2013

Keywords

  • Blinding
  • Conditioning
  • Covariates
  • Randomisation

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