European Medicines Agency, 7 Westferry Circus, E14 4HB London, UK.
Stat Med. 2012 Dec 30;31(30):4146-53. doi: 10.1002/sim.5361. Epub 2012 Jun 27.
Occasionally, things go so wrong in a clinical trial that a change must be made. For example, the originally planned primary outcome may be measured completely unreliably. Is there any recourse? One may still be able to salvage the trial using a permutation test if a change is made before breaking the treatment blind. The solution is not a panacea; we discuss the limitations and legitimate grounds for criticism. Still, when it is needed, the procedure is preferable to rigid adherence to a design that makes no sense. Published 2012. This article is a US Government work and is in the public domain in the USA.
偶尔，临床试验中会出现非常严重的问题，以至于必须进行更改。例如，最初计划的主要结果可能完全不可靠。有什么补救措施吗？如果在打破治疗盲法之前进行更改，仍然可以使用排列检验来挽救试验。该解决方案并非万无一失；我们讨论了局限性和批评的合理依据。尽管如此，在需要时，该程序比坚持毫无意义的设计更为可取。2012 年出版。本文是美国政府的一项工作，在美国属于公有领域。
