The unblinding of statisticians in clinical trials: commentary on Iflaifel et al., Trials 2023

Abstract

Abstract Recently, the Blinding of Trial Statisticians research team, Iflaifel and colleagues, have produced detailed guidance regarding the blinding or unblinding of statisticians in clinical trials, based on substantial mixed-methods work. I wish to comment on the research findings. In particular, I argue that open-label trials, non-drug trials, or non-inferiority trials should not be treated any differently from blinded superiority trials with regards to the risk of bias assessment. Prevention of bias should be the priority for definitive randomised controlled trials, regardless of the precise study design.

Keywords

• Clinical trials
• RCT
• Blinding
• Statisticians
• Clinical trials unit