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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 . 2006 . Peer-reviewed
License: Wiley TDM
Data sources: Crossref
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Standardversus adaptive monitoring procedures: a commentary

Authors: Thomas R, Fleming;

Standardversus adaptive monitoring procedures: a commentary

Abstract

In the standard approach to designing definitive clinical trials, the primary endpoint and test statistic to be used for the primary analysis are specified before trial initiation. The false positive error rate for the null hypothesis and statistical power to detect the targeted size of treatment effect are also specified. Standard monitoring procedures, such as the group sequential guidelines, enable interim monitoring while maintaining the integrity of this approach. In contrast, adaptive monitoring procedures seek to provide flexibility to modify these pre-specified design features during the course of the trial. However, these procedures have several undesirable properties, including lesser statistical efficiency, reduced interpretability of primary outcome results, basing design changes on unreliable interim estimates of efficacy, risks to the integrity and credibility of the trial, loss of flexibility to use emerging results from external sources to alter key design features, and overemphasis of the importance of statistical significance relative to clinical significance.

Related Organizations
Keywords

Clinical Trials as Topic, Data Interpretation, Statistical, Sample Size, Humans, Clinical Trials Data Monitoring Committees

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    influence
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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!
39
Top 10%
Top 10%
Top 10%
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