Real-World Evidence in External Control Arms: Driving Innovation in Drug Development

Speaker(s)

Faculty: Leanne Larson, MHA, ZS Associates, Wilmette, IL, USA Doug Foster, MBA, Advanced Data Sciences, SAN FRANCISCO, CA, USA; Ulka Campbell, PhD, MPH, Aetion, Inc, New York, NY, USA; Aaron Kamauu, MPH, MS, MD, Navidence LLC, Bountiful, UT, USA

Separate registration required.

Gain new skills in the use of real-world evidence (RWE) in external control arms (ECAs) – an advanced application that has become critical in drug development. During this course you will learn more about the history and regulatory landscape of the application of ECAs and how to analyze the current regulatory and payer landscape for ECA acceptance and application in drug development and market access. You will explore the relevant data sources and sourcing methodologies for ECAs and learn how to develop external control arms using synthetic data and data from multiple data sources. End the course by designing and developing an external control arm with your peers.

PREREQUISITE: To get the most out of the course, students should be familiar with basic definitions and concepts of RWE including regulatory applications.

Code

007

Topic

Real World Data & Information Systems