Dataset Information

Sample size calculations for blinding assessment.

ABSTRACT: Blinding is a critical component in randomized clinical trials along with treatment effect estimation and comparisons between the treatments. Various methods have been proposed for the statistical analyses of blinding-related data, but there is little guidance for determining the sample size for this type of data, especially if blinding assessment is done in pilot studies. In this paper, we try to fill this gap and provide simple methods to address sample size calculations for a "new" study with different research questions and scenarios. The proposed methods are framed in terms of estimation/precision or statistical testing to allow investigators to choose the best suited method for their goals. We illustrate the methods using worked examples with real data.

SUBMITTER: Landsman V

PROVIDER: S-EPMC5960641 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Sample size calculations for blinding assessment.

Landsman Victoria V Fillery Mark M Vernon Howard H Bang Heejung H

Journal of biopharmaceutical statistics 20171120 5

Blinding is a critical component in randomized clinical trials along with treatment effect estimation and comparisons between the treatments. Various methods have been proposed for the statistical analyses of blinding-related data, but there is little guidance for determining the sample size for this type of data, especially if blinding assessment is done in pilot studies. In this paper, we try to fill this gap and provide simple methods to address sample size calculations for a "new" study with ...[more]

PMID: 29157126

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Dataset Information

Sample size calculations for blinding assessment.

Publications

Sample size calculations for blinding assessment.

Similar Datasets

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