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Risk-based monitoring allows monitors of clinical trial sites to focus their visits on sites with the greatest potential for risk reduction. Here we present a statistical model that recommends sites for the monitor to visit. The model makes use of a pre-visit assessment supplied by the monitor, as well as other measurable factors, to predict the monitor’s post-visit assessment of the risk reduction resulting from the visit. The monitor is then directed to visit the sites with the highest predicted risk reduction. We demonstrate the properties of this model using a simulation. Our simulation compares two strategies for directing monitors, one of which relies on the model, while the other strategy relies only on the monitor’s pre-visit assessments. Our simulation demonstrates that the model-based strategy can direct the monitors to sites with greater potential for risk reduction. Finally, we discuss alternative models as well as potential pitfalls of risk-based monitoring.
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- A Statistical Model for Risk-Based Monitoring of Clinical Trials
Gregory J. Hather
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