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关于临床试验中随机化和可加性的争议。

Controversies concerning randomization and additivity in clinical trials.

作者信息

Senn Stephen

机构信息

Department of Statistical Science, University College London, London WC1E 6BT, UK.

出版信息

Stat Med. 2004 Dec 30;23(24):3729-53. doi: 10.1002/sim.2074.

Abstract

'As ye randomise so shall ye analyse', is one way of describing Fisher's defence of randomization. Yet, when it comes to clinical trials we nearly always randomize but we rarely analyse the way we randomize and Fisher himself was no exception. Two controversies involving Fisher in the 1930s are discussed: one with Neyman concerning additivity and the other with Student concerning randomization. Their relevance today is considered, as is whether randomization inference in clinical trials is dead and whether modelling rules the day, whether minimization is an acceptable procedure and to what extent trialists confuse experiments with surveys. It will be maintained that a number of different possible purposes of clinical trials have been confused because in the case of the general linear model, under strong additivity, they can all be satisfied by a single analysis. More generally, however, this is not the case.

摘要

“随机化的方式决定分析的方式”,这是描述费希尔对随机化辩护的一种说法。然而,在临床试验中,我们几乎总是进行随机化,但我们很少按照随机化的方式进行分析,费希尔本人也不例外。文中讨论了20世纪30年代涉及费希尔的两场争论:一场是与内曼关于可加性的争论,另一场是与“学生”关于随机化的争论。文中考虑了它们在当今的相关性,以及临床试验中的随机化推断是否已死、建模是否主导一切、最小化是否是可接受的程序,以及试验者在多大程度上混淆了实验与调查。有人认为,临床试验的一些不同可能目的被混淆了,因为在一般线性模型的情况下,在强可加性条件下,它们都可以通过单一分析得到满足。然而,更普遍的情况并非如此。

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