Graduate Prerequisites: SPH BS851; or consent of instructor - This course covers a variety of biostatistical topics in clinical trials, including presentation of statistical results to regulatory agencies for product approval, analysis of safety data, intent-to-treat analyses and handling of missing data, interim analyses and adaptive designs, and analyses of multiple endpoints. Upon completion of the course, students will be able to make and defend decisions for many study designs and for issues faced when analyzing efficacy and safety data from clinical trials. Students will also be able to present, in a written format following standard guidelines accepted by the clinical trials' community, results of such efficacy and safety analyses to the medical reviewers and statistical reviewers of regulatory agencies.

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