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

Iflaifel, Mais; Partlett, Christopher; Bell, Jennifer; Cook, Andrew; Gamble, Carrol; Julious, Steven; Juszczak, Edmund; Linsell, Louise; Montgomery, Alan; Sprange, Kirsty

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


Authors

Mais Iflaifel

CHRIS PARTLETT Chris.Partlett@nottingham.ac.uk
Assistant Professor of Medical Statistics and Clinical Trials

Jennifer Bell

Andrew Cook

Carrol Gamble

Steven Julious

Louise Linsell

ALAN MONTGOMERY ALAN.MONTGOMERY@NOTTINGHAM.AC.UK
Director Nottingham Clinical Trials Unit



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 transcripts. Results: Thirty-seven participants from 19 CTUs participated in one of six focus groups. Four main themes were identified, namely statistical models of work, factors affecting the decision to blind statisticians, benefits of blinding/not blinding statisticians and practicalities. Factors influencing the decision to blind the statistician included available resources, study design and types of intervention and outcomes and analysis. Although blinding of the statistician is perceived as a desirable mitigation against bias, there was uncertainty about the extent to which an unblinded statistician might impart bias. Instead, in most cases, the insight that the statistician offers was deemed more important to delivery of a trial than the risk of bias they may introduce if unblinded. Blinding of statisticians was only considered achievable with the appropriate resource and staffing, which were not always available. In many cases, a standard approach to blinding was therefore considered unrealistic and impractical; hence the need for a proportionate risk assessment approach identifying possible mitigations. Conclusions: There was wide variation in practice between UK CTUs regarding the blinding of trial statisticians. A risk assessment approach would enable CTUs to identify risks associated with unblinded statisticians conducting the final analysis and alternative mitigation strategies. The findings of this study will be used to design guidance and a tool to support this risk assessment process.

Citation

Iflaifel, M., Partlett, C., Bell, J., Cook, A., Gamble, C., Julious, S., …Sprange, K. (2022). Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units. Trials, 23(1), Article 535. https://doi.org/10.1186/s13063-022-06481-9

Journal Article Type Article
Acceptance Date Jun 14, 2022
Online Publication Date Jun 27, 2022
Publication Date Dec 1, 2022
Deposit Date Sep 1, 2022
Publicly Available Date Sep 1, 2022
Journal Trials
Electronic ISSN 1745-6215
Publisher Springer Science and Business Media LLC
Peer Reviewed Peer Reviewed
Volume 23
Issue 1
Article Number 535
DOI https://doi.org/10.1186/s13063-022-06481-9
Keywords Pharmacology (medical); Medicine (miscellaneous)
Public URL https://nottingham-repository.worktribe.com/output/8857452
Publisher URL https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06481-9