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image/svg+xml Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao Closed Access logo, derived from PLoS Open Access logo. This version with transparent background. http://commons.wikimedia.org/wiki/File:Closed_Access_logo_transparent.svg Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao Statistics in Medici...arrow_drop_down
image/svg+xml Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao Closed Access logo, derived from PLoS Open Access logo. This version with transparent background. http://commons.wikimedia.org/wiki/File:Closed_Access_logo_transparent.svg Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao
Statistics in Medicine
Article . 2018 . Peer-reviewed
License: Wiley Online Library User Agreement
Data sources: Crossref
image/svg+xml Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao Closed Access logo, derived from PLoS Open Access logo. This version with transparent background. http://commons.wikimedia.org/wiki/File:Closed_Access_logo_transparent.svg Jakob Voss, based on art designer at PLoS, modified by Wikipedia users Nina and Beao
zbMATH Open
Article . 2019
Data sources: zbMATH Open
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Randomization: The forgotten component of the randomized clinical trial

Randomization: the forgotten component of the randomized clinical trial
Authors: William F. Rosenberger; Diane Uschner; Yanying Wang;

Randomization: The forgotten component of the randomized clinical trial

Abstract

“…The customary test for an observed difference…is based on an enumeration of the probabilities, on the initial hypothesis that two treatments do not differ in their effects,…of all the various results which would occur if the trial were repeated indefinitely with different random samples of the same size as those actually used.” –Peter Armitage (“Sequential tests in prophylactic and therapeutic trials” in Quarterly Journal of Medicine, 1954;23(91):255‐274). Randomization has been the hallmark of the clinical trial since Sir Bradford Hill adopted it in the 1946 streptomycin trial. An exploration of the early literature yields three rationales, ie, (i) the incorporation of randomization provides unpredictability in treatment assignments, thereby mitigating selection bias; (ii) randomization tends to ensure similarity in the treatment groups on known and unknown confounders (at least asymptotically); and (iii) the act of randomization itself provides a basis for inference when random sampling is not conducted from a population model. Of these three, rationale (iii) is often forgotten, ignored, or left untaught. Today, randomization is a rote exercise, scarcely considered in protocols or medical journal articles. Yet, the literature of the last century is rich with statistical articles on randomization methods and their consequences, authored by some of the pioneers of the biostatistics and statistics world. In this paper, we review some of this literature and describe very simple methods to rectify some of the oversight. We describe how randomization‐based inference can be used for virtually any outcome of interest in a clinical trial. Special mention is made of nonstandard clinical trials situations.

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Keywords

Random Allocation, randomization as a basis for inference, Data Interpretation, Statistical, Humans, history of randomization, randomization tests, Applications of statistics to biology and medical sciences; meta analysis, Randomized Controlled Trials as Topic

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
68
Top 1%
Top 10%
Top 10%
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