Label Expansion of a Diabetes Medication using Observational Cohort Study with RWD / RWE

This study explores the use of real-world data and evidence (RWD/E) from observational cohort studies to support label expansion for a diabetes medication. The study design utilizes real-world data to assess the medication’s effectiveness in a broader patient population, potentially leading to a more detailed understanding of its benefits. This approach offers advantages in terms of cost-efficiency and the findings can be applied to a larger group of people, unlike traditional randomized controlled trials.