Randomised consent designs in cancer clinical trials

被引：48

作者：

Altman, DG

Whitehead, J

Parmar, MKB

Stenning, SP

Fayers, PM

Machin, D

机构：

[1] UNIV READING, MED & PHARMACEUT STAT RES UNIT, READING RG6 6FN, BERKS, ENGLAND

[2] MRC, CLIN TRIALS OFF, CAMBRIDGE CB2 2BW, ENGLAND

来源：

EUROPEAN JOURNAL OF CANCER | 1995年 / 31A卷 / 12期

关键词：

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

D O I：

10.1016/0959-8049(95)00470-X

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：1934 / 1944

页数：11

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