Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study.

ABSTRACT:

Background

Existing guidelines recommend statisticians remain blinded to treatment allocation prior to the final analysis and that any interim analyses should be conducted by a separate team from the one undertaking the final analysis. However, there remains substantial variation in practice between UK Clinical Trials Units (CTUs) when it comes to blinding statisticians. Therefore, the aim of this study was to develop guidance to advise CTUs on a risk-proportionate approach to blinding statisticians within clinical trials.

Methods

This study employed a mixed methods approach involving three stages: (I) a quantitative study using a cohort of 200 studies (from a major UK funder published between 2016 and 2020) to assess the impact of blinding statisticians on the proportion of

SUBMITTER: Iflaifel M 

PROVIDER: S-EPMC9887916 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature