|
Abstract:
|
In this talk, we will discuss the benefits and concerns of using real-world data in the drug development phase prior to regulatory approval and market launch. The main focus is on how to leverage real-world data to generate more relevant hypotheses in designing clinical trials, including clinically plausible treatment effect size, target patient population selection, feasibility assessment etc. We propose a Bayesian framework to incorporate real-world data. Simulation scenarios and case studies in immunology and oncology will be presented.
|
