Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units.

ABSTRACT:

Background

Blinding is an established approach in clinical trials which aims to minimise the risk of performance and detection bias. There is little empirical evidence to guide UK clinical trials units (CTUs) about the practice of blinding statisticians. Guidelines recommend that statisticians remain blinded to allocation prior to the final analysis. As these guidelines are not based on empirical evidence, this study undertook a qualitative investigation relating to when and how statisticians should be blinded in clinical trials.

Methods

Data were collected through online focus groups with various stakeholders who work in the delivery and oversight of clinical trials. Recordings of the focus groups were transcribed verbatim and thematic analysis was used to analyse the trans

SUBMITTER: Iflaifel M 

PROVIDER: S-EPMC9235168 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature