M306- Clinical Trial Design

This course aims to teach the fundamentals of clinical trial design through lectures, discussions, and development of clinical trial protocols. Classroom lectures will cover clinical trial phases, choosing appropriate endpoints, commonly used clinical trial designs in oncology, randomization, interim analyses, and novel trial methods, such as basket trials and master protocols. We will also cover patient reported outcomes, integrative medicine, and imaging studies. Scholars will also learn about using real world data, barriers to accrual, and presenting trials to the DSMB/DSMC. Discussions will incorporate lecture themes. The scholars will choose a clinical trial to develop and then methodically develop their own protocol during the protocol development segment of the course. Protocols will be presented to the class.