title: Randomised consent designs in cancer clinical trials.
abstract: 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.
authors.affiliation: Medical Statistics Laboratory, Imperial Cancer Research Fund, Lincoln's Inn Fields, London, U.K.
authors.forename: D G
authors.initials: DG
authors.lastname: Altman
authors.forename: J
authors.initials: J
authors.lastname: Whitehead
authors.forename: M K
authors.initials: MK
authors.lastname: Parmar
authors.forename: S P
authors.initials: SP
authors.lastname: Stenning
authors.forename: P M
authors.initials: PM
authors.lastname: Fayers
authors.forename: D
authors.initials: D
authors.lastname: Machin
mesh_terms: D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent; D009369:Neoplasms / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D012107:Research Design