Clinical Trial Design in the Age of Precision Medicine and Health

Description

Traditional designs for Phase I, II, and III clinical trials for medical product approval and Phase IV postmarketing studies for safety evaluation cost too much and take too much time in the era of precision medicine and precision health. This course introduces innovative designs that have been developed for aordable clinical trials, which can be completed within reasonable time constraints and which have been encouraged by regulatory agencies.

Note: This course is cross listed with BIODS248 and STATS248

What you will learn

• Statistical considerations for novel designs in phase I-II trials
• Enrichment designs with adaptive patient subgroup selection, with examples from cancer and stroke therapies
• Master protocols for umbrella, platform and basket trials, with concrete examples
• Real-world evidence and patient-focused medical product development

Prerequisites

• STATS200 or equivalent
• Working knowledge of statistics and R