Statistics Seminar - "Statistical Power of Drug Development", Melanie Poulin-Costello
Department of Mathematics and Statistics
Title: Statistical Power of Drug Development
Abstract: The steps in drug development have been well established for many years: pre-clinical to clinical trials in phases I, II then III leading to a submission to a health authority and finally drug approval and marketing. The status quo is challenged and statistics play a powerful role in devising creative new paths to get patients faster access to the medicines they need. Several novel approaches to drug development including the use of real world data, umbrella and basket trials and early decision criteria will be presented. The role of the statistician throughout the clinical trial and drug development process will be highlighted.