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Are External Control Arms Ready for Primetime?
Session Chair(s)
Zoe Li, MBA
Director, Life Sciences
COTA, United States
There are increasing examples of companies submitting real-world data as part of an external control arm. This panel will discuss whether external control arms are really ready for regulatory use and what it will take to achieve broader acceptance.
Learning Objective : Describe how and when to use control arms; Discuss the risks and benefits; Identify the FDA's willingness to accept external comparators in regulatory submissions.
Speaker(s)
Panelist
Ravinder Dhawan, PhD
Merck & Co., Inc., United States
Vice President, Outcomes Research, Oncology CORE
Panelist
Leah Burns, MPH
Bristol-Myers Squibb Company, United States
Group Director, Real World Evidence Strategy
Panelist
Aaron Kamauu, MD, MPH, MS
Navidence LLC, United States
CEO
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