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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 . 1997 . Peer-reviewed
License: Wiley TDM
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
Statistics in Medicine
Article . 1997 . Peer-reviewed
License: Wiley TDM
Data sources: Crossref
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TUTORIAL IN BIOSTATISTICS: BAYESIAN DATA MONITORING IN CLINICAL TRIALS

Authors: P M, Fayers; D, Ashby; M K, Parmar;

TUTORIAL IN BIOSTATISTICS: BAYESIAN DATA MONITORING IN CLINICAL TRIALS

Abstract

Many clinical trials organizations use regular interim analyses to monitor the accruing results in large clinical trials. In disease areas such as cancer, where survival is usually a major outcome variable, ethical considerations may lead to a stipulated requirement for data monitoring of mortality. This monitoring has frequently taken the form of limiting interim analyses to be few in number, and specifying an extreme p-value of, for example, p < 0.001 or p < 0.01 as grounds for early termination of the trial. Group-sequential methods are also used. However, none of these approaches formally assesses the impact that the results of a clinical trial may have upon clinical practice. Thus a trial might be terminated early because of apparent treatment benefits, but might fail to influence sceptical clinicians to modify their future treatment policy. We discuss the application of Bayesian methods, including the use of uninformative, sceptical and enthusiastic priors, and demonstrate that the necessary calculations are both straightforward to perform and easy to interpret statistically and clinically. Methods are illustrated with interim analyses of a clinical trial in oesophageal cancer.

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Keywords

Clinical Trials as Topic, Likelihood Functions, Esophageal Neoplasms, Bayes Theorem, Combined Modality Therapy, Survival Analysis, Esophagectomy, Treatment Outcome, Chemotherapy, Adjuvant, Data Interpretation, Statistical, Humans, Proportional Hazards Models

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    81
    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.
    Top 10%
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
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    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Top 10%
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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!
81
Top 10%
Top 1%
Top 10%
Related to Research communities
Cancer Research
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