Randomised consent designs in cancer clinical trials

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

doi:10.1016/0959-8049(95)00470-X

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

Applied Health Sciences

Research output: Contribution to journal › Review article › peer-review

52 Citations (Scopus)

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.

Original language	English
Pages (from-to)	1934-1944
Number of pages	11
Journal	European Journal of Cancer
Volume	31
Issue number	12
DOIs	https://doi.org/10.1016/0959-8049(95)00470-X
Publication status	Published - Nov 1995

Keywords

cancer
clinical trials
ethics
randomised consent design
statistics

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/0959-8049(95)00470-XLicence: Unspecified

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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.",

keywords = "cancer, clinical trials, ethics, randomised consent design, statistics",

author = "Altman, {D. G.} and J. Whitehead and Parmar, {M. K.B.} and Stenning, {S. P.} and Fayers, {P. M.} and D. Machin",

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AU - Altman, D. G.

AU - Whitehead, J.

AU - Parmar, M. K.B.

AU - Stenning, S. P.

AU - Fayers, P. M.

AU - Machin, D.

PY - 1995/11

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N2 - 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.

AB - 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.

KW - cancer

KW - clinical trials

KW - ethics

KW - randomised consent design

KW - statistics

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U2 - 10.1016/0959-8049(95)00470-X

DO - 10.1016/0959-8049(95)00470-X

M3 - Review article

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EP - 1944

JO - European Journal of Cancer

JF - European Journal of Cancer

SN - 0959-8049

IS - 12

ER -

Randomised consent designs in cancer clinical trials

Abstract

Keywords

UN SDGs

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