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Abstract:
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Safety assessment is crucial in drug development. Pharmaceutical companies and regulatory agencies collect large amounts of safety data, which usually include adverse events, laboratory measurements, concomitant medications, etc. However, the analysis of safety data often has not received sufficient attention. As part of risk management, safety data should be continuously monitored and analyzed during clinical trials. Graphical analyses can maximize the ability to detect any unexpected and unusual features in clinical trial safety data. We present several graphs that have been developed to better visualize different types of clinical trial safety data and facilitate safety signal detection. These graphs are conveniently embedded in the Insightful Miner workflow, which not only allows users to analyze the data more interactively, but also streamlines the safety monitoring process.
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