Nottingham Clinical Trials Unit
The University of Nottingham
University of Nottingham
  

BOTS: Blinding of Trial Statisticians

 

There is good empirical evidence of the benefit of blinding participants, clinicians, and outcome assessors in clinical trials to reduce the risk of bias and to improve the trust and credibility of the results. However, it is not clear if blinding of other members of the trial team, such as statisticians, also reduces the risk of bias.

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Existing guidelines recommend blinding the trial statisticians before the end of the trial, but do not consider the trial-specific risk of blinding or not blinding the statistician. The goal of this study is to identify and provide evidence for a risk proportionate strategy for blinding statisticians in clinical trials.

The study will be comprised of three main parts:

    •      A qualitative study to determine the views and opinions of key stakeholders 
    •      A quantitative study to assess the impact of blinding on trial outcomes/results
    •      Combining the results of qualitative and quantitative along with a stakeholder meeting to produce guidance for clinical trials units

Research team 

The study co-investigators are Dr Mais Iflaifel, Dr Christopher Partlett, Ms Kirsty Sprange, Ms Jennifer Bell, Dr Andrew Cook, Prof Carrol Gamble, Prof Steven Julious, Prof Ed Juszczak, Dr Louise Linsell, Prof. Alan Montgomery. 

Funding 

The project is funded by the NIHR Clinical Trials Unit Support Funding Opportunity – Supporting efficient / innovative delivery of NIHR research (June 2020).

Study documents 

Contact

If you have any enquiries, please get in touch with us via email: ms-bots@nottingham.ac.uk

 

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Nottingham Clinical Trials Unit

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