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Central Monitoring Use in Early-Phase and Small Enrollment Trials

Central monitoring is highly effective in detecting emerging quality issues in clinical trials, but debate continues over its use in early-phase and small enrollment studies due to typically lower data volumes and shorter study timelines. In this analysis, we summarized industry trends in early-phase and small trials using data from the CluePoints central monitoring platform. Out of the 1,062 studies using the platform, 140 were Phase I (13%), 378 were Phase II (36%), and across all phases we observed 175 trials with 100 or fewer enrolled patients (16%) and 65 more with 50 or fewer enrolled patients (6%).

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A Comprehensive Guide to Adaptive Site Monitoring

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