Sample size calculations for blinding assessment. Issue 5 (3rd September 2018)

• Record Type: Journal Article
• Authors: Landsman, Victoria; Fillery, Mark; Vernon, Howard; Bang, Heejung
• Is Part Of: Journal of biopharmaceutical statistics. Volume 28:Issue 5(2018)
• Page Start: 857
• Page End: 869
• Publication Date: 2018-09-03
• Subjects: Blinding index -- clinical trial -- contingency table -- masking -- patient blinding; Pharmacy -- Statistical methods -- Periodicals; Drugs -- Testing -- Statistical methods -- Periodicals; Biometry -- Periodicals; Biopharmaceutics -- Periodicals; Pharmacokinetics -- Periodicals; 615.19
• DOI: 10.1080/10543406.2017.1399898
• Languages: English
• ISSNs: 1054-3406

Abstract

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.