Handling Missing Data in Analgesic Clinical Trials; Dropouts, Regulatory Strategies and Practical Implications
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When it comes to subject dropouts, an ounce of prevention is worth a pound of cure. Subject and study staff education can reduce dropout rates. The lecture will focus on educational paradigms designed to reduce dropouts and their efficacy. Regardless of technique, dropouts cannot be eliminated. When dropouts occur, they need to be statistically accounted for utilizing accepted imputation methods. In the recently released FDA draft analgesic guidance, a significant amount discussion was devoted to the appropriate statistical handling of missing data. Dr. Singla will provide a primer on accepted imputation techniques for acute and chronic analgesic studies.
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