Altman D G, Whitehead J, Parmar M K, Stenning S P, Fayers P M, Machin D
Medical Statistics Laboratory, Imperial Cancer Research Fund, Lincoln's Inn Fields, London, U.K.
Eur J Cancer. 1995 Nov;31A(12):1934-44. doi: 10.1016/0959-8049(95)00470-x.
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.
1977年，泽伦提出了一种新的临床试验设计，旨在通过避免一些与获得知情同意相关的问题来增加受试者招募。这些“随机同意”设计已被证明存在争议，且使用并不频繁。本文解释了单随机同意设计和双随机同意设计的统计学方面，并审视了一些伦理问题。对所有已识别出的采用随机同意设计的已发表癌症治疗试验进行了详细考量。总结了支持和反对使用这些设计的理由。
