Optimising trial monitoring on the AZURE trial

Abstract

Methods Determining how academic clinical trials units can optimise data quality via central monitoring methods is an important factor in trial management. In the AZURE trial, it became apparent from site monitoring that the endpoint dates as defined in EORTC literature [1] were misinterpreted at site. Although a training programme was initiated, some sites were seen to report date of confirmation rather than date of onset/suspicion as required. Therefore the focus of site monitoring was changed to review this critical endpoint data. Due to limited trial monitoring resources, a review of telephone monitoring was implemented. A pilot phase was implemented to review the practicalities and possible results which could be obtained using telephone monitoring. During the pilot phase 17 trial endpoints were reviewed which had been verified by both site and telephone monitoring.