Abstract
BackgroundLarge multicentre trials are complex and expensive projects. A key factor for their successful planning and delivery is how well sites meet their targets in recruiting and retaining participants, and in collecting high-quality, complete data in a timely manner. Collecting and monitoring easily accessible data relevant to performance of sites has the potential to improve trial management efficiency. The aim of this systematic review was to identify metrics that have either been proposed or used for monitoring site performance in multicentre trials.MethodsWe searched the Cochrane Library, five biomedical bibliographic databases (CINAHL, EMBASE, Medline, PsychINFO and SCOPUS) and Google Scholar for studies describing ways of monitoring or measuring individual site performance in multicentre randomised trials. Records identified were screened for eligibility. For included studies, data on study content were extracted independently by two reviewers, and disagreements resolved by discussion.ResultsAfter removing duplicate citations, we identified 3188 records. Of these, 21 were eligible for inclusion and yielded 117 performance metrics. The median number of metrics reported per paper was 8, range 1–16. Metrics broadly fell into six categories: site potential; recruitment; retention; data collection; trial conduct and trial safety.ConclusionsThis review identifies a list of metrics to monitor site performance within multicentre randomised trials. Those that would be easy to collect, and for which monitoring might trigger actions to mitigate problems at site level, merit further evaluation.
Highlights
Large multicentre trials are complex and expensive projects
The median number of performance metrics reported per study was 8, with the range being 1–16
Those 117 metrics were screened, to exclude any judged as: lacking sufficient clarity; being unrelated to individual site performance; being too specific to an individual trial methodology or pertaining to clinical outcomes not trial performance. This left 87 performance metrics to be considered for use in day-to-day trial management
Summary
Large multicentre trials are complex and expensive projects. A key factor for their successful planning and delivery is how well sites meet their targets in recruiting and retaining participants, and in collecting highquality, complete data in a timely manner. A recent query to all UK Clinical Research Collaboration (UKCRC), registered Clinical Trials Units (CTUs) revealed that many units routinely collect and report data for each site in a trial; such as numbers randomised, case report forms (CRFs) returned, data quality, missing primary outcome data, and serious breaches. How such data are used to assess and manage performance varies widely [3,4,5,6,7]. Agreeing a small number of metrics for site performance that could be collected, presented and monitored in a standardised way by a trial manager or trial co-ordinator would be a potentially useful tool to improve efficient trial conduct
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