Dalla Lana School of Public Health

Advanced Statistical Methods for Clinical Trials

Course Description

Rigorously designed clinical trials are essential for the clinical development of novel therapies and interventions. This course will provide students with knowledge of advanced statistical methods required for the design and analysis of clinical trials across all phases of clinical development. The course will teach both traditional and complex trial designs, including trials with adaptive designs. Students will learn how to evaluate the operating characteristics of designs using statistical simulations and make informed choices in selecting an appropriate
design for the trial. Students will also learn about the role of a trial statistician including protocol writing, interim monitoring, analysis, and reporting.

Course Objectives

1. To understand the traditional and complex trial designs at each phase of clinical development.
2. To learn how to use statistical simulations to evaluate and compare the operating characteristics of competing trial designs.
3. To learn about the development of novel statistical methods in the design and analysis of clinical trials.
4. To learn about the role of a trial statistician including protocol writing, interim monitoring, analysis, and reporting.

Methods of Assessment