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Session 2: Early Development Use Cases
Session Chair(s)
Charles Lee, MBA, MS
Executive Regulatory Science Director
AstraZeneca, United States
This session will discuss the application of RWE in early clinical development and in supporting Regulatory decision-making. A case study will describe how external controls were used to augment the results of a single arm clinical trial in providing a perspective for program level decision making. Learnings from a review of FDA approvals during 2019-2023 on the uses of RWD in oncology applications will be presented. Examples and case studies of RWD use (other external control arms) in oncology regulatory applications will complement the first presentation on the use of external controls.
Learning Objective : - Determine the appropriateness of external control data
- Describe how to create a statistically balanced external control
- Use an external control to help inform the results of a single-arm study
- To understand how real-world data (RWD) have successfully and unsuccessfully supported regulatory applications in oncology
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To identify learnings about ensuring impactful use of RWD in oncology clinical development and regulatory applications
Speaker(s)
Why and How: An External Control Used to Contextualize the Results of an Early Phase Single Arm Metastatic Pancreatic Study
Lisa Ensign, PhD, MSc
Medidata, a Dassault Systemes Company, United States
VP, Statistics and Regulatory Science Innovation
Beyond External Control Arms: Utility of Real-World Data in Oncology Regulatory Applications
Ulka B Campbell, PhD
Aetion Inc, United States
Head of Scientific Strategy
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