Unplanned adaptations before breaking the blind | Zendy

Posch Martin | Zendy; Proschan Michael A. | Zendy

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Unplanned adaptations before breaking the blind

Author(s) -

Posch Martin,

Proschan Michael A.

Publication year - 2012

Publication title -

statistics in medicine

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 1.996

H-Index - 183

eISSN - 1097-0258

pISSN - 0277-6715

DOI - 10.1002/sim.5361

Subject(s) - panacea (medicine) , criticism , public domain , government (linguistics) , outcome (game theory) , domain (mathematical analysis) , computer science , medicine , political science , alternative medicine , economics , law , mathematical economics , mathematics , history , philosophy , mathematical analysis , linguistics , archaeology , pathology

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.

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