Advanced Randomized Controlled Trials

3 credits · Graduate School

This course presents advanced topics in design, analysis, and governance of clinical trials. Design topics include adaptive trials, pragmatic trials, sequential trials, cluster-randomized trials, and platform trials. Analysis topics include methods for handling missing data, estimand frameworks, Bayesian analysis methods, composite endpoints, and confirmatory and exploratory assessment of heterogeneous treatment effects. Governance topics include regulatory perspectives on advanced trial designs, informed consent in pragmatic trials, and other ethical and operational issues. This course is open to biostatistics PhD students only; for students in other programs, instructor permission is required to enroll. Prerequisites: BIOS 6321 and BIOS 6342. [3]