Module 8 – Part 5: Real-World Data (RWD) & Real-World Evidence (RWE)

This lecture by Dr. Jagdeep Podichetty provides an introduction to real-world data/real-world evidence (RWD/RWE) and how they can address some of the current challenges facing the pharmaceutical industry. It includes several considerations around the use of RWD/RWE. An overview of RWD/RWE landscape, types and sources of RWD, current applications of RWD/RWE in MIDD will be provided. Finally, the framework for evaluating RWD/RWE for regulatory decisions will be discussed.

This module is part of the educational series “Model-Informed Drug Development (MIDD): Methods Advancing Medical Products to Patients”. The educational content was developed for regulatory scientists by experts in the field in partnership with the Critical Path Institute and funded by FDA CDER Office of Translational Sciences. As part of Multidisciplinary Education and Exchange initiatives, CDER’s Quantitative Medicine Center of Excellence is making this resource accessible to all, supporting community-wide educational enrichment.

Disclaimer: The presentations in this educational series reflect the views of the presenters and should not be construed to represent FDA’s views or policies.