Premium
Site visits to initiate recruitment in a clinical trial: does it matter who conducts the visit? Protocol for implementation in trials
Author(s) -
Nollett Claire,
Kelson Mark,
Hood Kerenza
Publication year - 2016
Publication title -
journal of evidence‐based medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.885
H-Index - 22
ISSN - 1756-5391
DOI - 10.1111/jebm.12212
Subject(s) - protocol (science) , clinical trial , randomized controlled trial , principal (computer security) , medicine , research design , alternative medicine , medical education , computer science , computer security , sociology , pathology , social science
The Study Within a Trial (SWAT) program exists to ‘embed research within research, so as to resolve uncertainties about the different ways of designing, conducting, analyzing, 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 multicentre 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 that trials can implement to address this research question.