Randomised consent designs in cancer clinical trials

D. G. Altman*, J. Whitehead, M. K.B. Parmar, S. P. Stenning, P. M. Fayers, D. Machin

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

52 Citations (Scopus)


In 1977, Zelen proposed a new design for clinical trials with the aim of increasing recruitment by avoiding some of the problems associated with obtaining informed consent. These 'randomised consent' designs have proved controversial, and have not often been used. This paper explains the statistical aspects of single and double randomised consent designs and reviews some of the ethical issues. All identified published cancer treatment trials using a randomised consent design are considered in some detail. Reasons for and against the use of these designs are summarised.

Original languageEnglish
Pages (from-to)1934-1944
Number of pages11
JournalEuropean Journal of Cancer
Issue number12
Publication statusPublished - Nov 1995


  • cancer
  • clinical trials
  • ethics
  • randomised consent design
  • statistics


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