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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 practice between UK Clinical Trials Units (CTUs) when it …