Site visits to initiate recruitment in a clinical trial: Does it matter who conducts the visit? Protocol for implementation in trials

摘要

The Study Within A Trial (SWAT) programme exists to ‘embed research within research, so as to resolve uncertainties about the different ways of designing, conducting, analysing and interpreting evaluations of health and social care’ (1). Published in this journal in 2013, a template for the first SWAT protocol outlined an investigation into the effects of site visits by the Principal Investigator on recruitment in multi-centre randomized controlled trials (1). We have now designed a SWAT protocol to extend this question and ask ‘does it matter who conducts the site visit?’ Our aim is to provide a protocol which trials can implement to address this research question.