A systematic search for reports of site monitoring technique comparisons in clinical trials

BackgroundAs part of a broader methodological programme of work around clinical trial monitoring, we wanted to evaluate the existing evidence for the effectiveness of different monitoring techniques.PurposeTo identify and evaluate prospective studies of the effectiveness of different monitoring strategies.MethodsA systematic search of MEDLINE from 1950 onwards, using free-text terms to identify relevant published studies. We intended to extract data on details of comparative techniques, monitoring findings identified by different techniques, and recommendations or identification of areas in need of further research made by authors.ResultsA total of 1222 published abstracts were identified and reviewed. Of these, nine articles described methods for quality control (QC) of clinical trial activities, and one article was identified that compared the same monitoring technique at two timepoints. None included a direct comparison of different monitoring techniques and findings.LimitationsThe search strategy was ...