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Sheraton Philadelphia Downtown Hotel

Oct 24, 2024 7:30 AM - Oct 25, 2024 4:10 PM

201 North 17th Street, Philadelphia, PA 19103

Real-World Evidence Conference

Translating Insights into Real-World Value

Session 2: Early Development Use Cases

Session Chair(s)

Charles  Lee, MBA, MS

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
  • To identify learnings about ensuring impactful use of RWD in oncology clinical development and regulatory applications

Speaker(s)

Lisa  Ensign, PhD, MSc

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

Ulka B Campbell, PhD

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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