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Priority setting in uncertainties in trial methodology

Challenges in how clinical trials are designed and conducted are commonly experienced by researchers at different stages of the research process. For example, difficulty in recruiting people to a trial often results in a delay in completing the trial or difficulty in using the trial results to make informed decisions about clinical care. For this reason, it is important that research into how trials might be ‘better done’ is considered so that the strength of trials’ findings are increased. There remains uncertainties on many aspects of trial design and conduct; for example, how best to distribute information effectively so participants fully understand the purpose of the trial or how best to collect the information or outcome data from the trial. The proposed KEDS activity will help identify, and prioritise, these methodological uncertainties by bringing together people, across the UK and Ireland who are involved directly in designing, conducting and taking part in clinical trials. This bringing together of people will engage researchers, clinicians and the public, in an exercise of discussion, knowledge exchange and consensus, in identifying, agreeing, prioritising and disseminating a list of the most important uncertainties surrounding trial methodology. The critical end point of the activity will be a ‘top-ten’ list of these uncertainties, determined by those directly involved in trials, which will be used to inform future research. Further, ongoing partner engagement in designing future studies will be encouraged and supported so that trials might be better designed and implemented in the future.