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January 2014

The Evolution of CluePoints’ SMART Engine

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Regarding CluePoints’ statistical approach to risk-based monitoring in clinical trials, we are often asked questions about sample size, such as: “How many subjects are needed per site to perform your analyses in an ongoing study?” “Do you have a minimum sample size recommendation for this approach?” “How can this be applied to trials with many centers and few patients in each center?”

Previously, our recommendation was at least 4 patients per center and 10 centers per study, although it was possible to group the data differently (e.g.…