Statistical Designs for Clinical Trials

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1500

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STAT 519 and STAT 615 Description: This course provides a comprehensive introduction to statistical designs used in clinical trials. It covers key concepts relevant to a biostatistician’s daily responsibilities in trial design, including different types of clinical trials (Phase I to Phase III), (adaptive) randomization methods, and sample size and power calculations. The course will also introduce commonly used design strategies in clinical trials, incorporating both frequentist and Bayesian approaches. Topics include adaptive dose-finding designs, group-sequential designs, sample size re-estimation, and sequential monitoring. Additionally, the course will cover advanced topics such as innovative designs for precision medicine, basket and platform trials, and trials utilizing complex endpoints. MD Anderson cancer trials will be used as motivating and illustrative examples throughout the course. By the end of the course, students are expected to be able to independently design standard clinical trials. No prior knowledge of biology or medicine is required, and basic Bayesian statistical concepts will be introduced→STAT 630→unlocks 0 courses

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