Unplanned adaptations before breaking the blind

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 t...

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Detalles Bibliográficos
Autores principales: Poscha, Martin, Proschanb, Michael A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Ltd 2012
Materias:
Special Issue Papers
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3576479/
https://www.ncbi.nlm.nih.gov/pubmed/22736397
http://dx.doi.org/10.1002/sim.5361
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author Poscha, Martin
Proschanb, Michael A.
author_facet Poscha, Martin
Proschanb, Michael A.
author_sort Poscha, Martin
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description 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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spelling pubmed-35764792013-02-25 Unplanned adaptations before breaking the blind Poscha, Martin Proschanb, Michael A. Stat Med Special Issue Papers 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. John Wiley & Sons, Ltd 2012-12-30 2012-06-27 /pmc/articles/PMC3576479/ /pubmed/22736397 http://dx.doi.org/10.1002/sim.5361 Text en Copyright © 2012 John Wiley & Sons, Ltd. http://creativecommons.org/licenses/by/2.5/ Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation.
spellingShingle Special Issue Papers
Poscha, Martin
Proschanb, Michael A.
Unplanned adaptations before breaking the blind
title Unplanned adaptations before breaking the blind
title_full Unplanned adaptations before breaking the blind
title_fullStr Unplanned adaptations before breaking the blind
title_full_unstemmed Unplanned adaptations before breaking the blind
title_short Unplanned adaptations before breaking the blind
title_sort unplanned adaptations before breaking the blind
topic Special Issue Papers
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3576479/
https://www.ncbi.nlm.nih.gov/pubmed/22736397
http://dx.doi.org/10.1002/sim.5361
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