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

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 practic...

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Bibliographic Details
Main Authors: Mais Iflaifel, Kirsty Sprange, Jennifer Bell, Andrew Cook, Carrol Gamble, Steven A. Julious, Edmund Juszczak, Louise Linsell, Alan Montgomery, Christopher Partlett
Format: Article
Language:English
Published: BMC 2023-01-01
Series:Trials
Subjects:
Blinding
Statisticians
Mixed methods
Stakeholder meeting
Clinical trials
Clinical trials unit
Online Access:https://doi.org/10.1186/s13063-022-06992-5

Internet

https://doi.org/10.1186/s13063-022-06992-5

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