Sample size calculations for blinding assessment

Publication type
Journal article
Authors
Landsman V Fillery M Vernon H Bang H
Date published
2018 Jan 01
Journal
Journal of Biopharmaceutical Statistics
Volume
28
Issue
5
Pages
857-869
PMID
29157126
Open Access?
No
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.