Added values - Controversies concerning randomization and additivity in clinical trials

Added values - Controversies concerning randomization and additivity in clinical trials
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DOI:
10.1002/sim.2074
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发表时间:
2004-12-30
影响因子:
2
通讯作者:
Senn, S
Senn, S
中科院分区:
医学3区
文献类型:
--
作者:
Senn, S

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‘你们随机化,你们就应该分析’,这是描述费舍尔对随机化的辩护的一种方式。然而,当谈到临床试验时,我们几乎总是随机化,但我们很少分析我们随机化的方式,费舍尔本人也不例外。讨论了20世纪30年代涉及Fisher的两场争论:一场是与Neyman关于可加性的争论,另一场是与Study关于随机化的争论。他们今天的相关性被考虑,临床试验中的随机化推理是否已经死亡,建模是否占主导地位,最小化是否是一个可接受的程序,以及试验者在多大程度上混淆了实验和调查。人们认为,临床试验的许多不同可能的目的已经被混淆,因为在一般线性模型的情况下,在强加性下,它们都可以通过单一分析来满足。然而,更广泛地说,情况并非如此。版权所有(C)2004 John Wiley Sons,Ltd.
'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. Copyright (C) 2004 John Wiley Sons, Ltd.