Duke-Margolis Center For Health Policy, United States
Increasing availability of real-world data (RWD) and real-world evidence (RWE) has created justifiable excitement for stakeholders. The applications of RWD and RWE seem limitless – from trial optimization, directing R&D spend, and defining risk-sharing arrangements and value. Also, the role of RWD and RWE is becoming increasingly important to drug development and patient safety and has been cited as a significant priority of the FDA. Yet, there is still a lot of work to be done before the use of RWD and RWE is widespread and truly impactful. The session will explore this potential as well as the areas for further exploration, alignment, methods, and infrastructure development. Also, the session will present a study conducted by Tufts Center for the Study of Drug Development that examines current RWE data uses, sources of data, how data is being integrated and operational approaches supporting RWD use.
Learning Objective : Discuss the current role of real world evidence and real-world data for use in clinical research and post-marketing safety applications among sponsor and CRO companies. Identify the significant challenges and return on investment with the use of real-world data and evidence.
The Use of Real-World Evidence and Data in Clinical Research and Postmarketing Safety Applications
Tufts Center For the Study of Drug Development, United States
How Real-World Evidence is Rapidly Changing Drug Development and Value Demonstration
Charles Makin, MBA, MS
Vice President and Global Head, RWE Late Phase Research
ICON, United States