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Session 2: The Selection and Use of External Comparators for Expedited Drug Development
Session Chair(s)
Robert Reynolds, DrSc, MSc, FISPE
Vice President, Epidemiology & Patient-Centered Outcomes, VEO
GSK, United States
Mark Stewart, PhD
Vice President, Science Policy
Friends of Cancer Research, United States
For certain clinical settings and scenarios, randomized control trials (RCTs) may be unethical or operationally infeasible. The use of real world data/evidence may provide additional context and supplementary evidence to support regulatory decisions and may be warranted due to the rarity of the disease, scarcity of patients, scientific concerns with data interpretability, or ethical considerations. This session will 1) discuss drug development scenarios that may benefit from the use of real world evidence specifically external comparators, also called synthetic, historical or virtual controls, that supplement or augment RCT data; 2) identify perceived barriers to the use and methodological approaches for constructing external comparator arms; and 3) describe use cases and operational considerations.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify clinical scenarios and settings where RWD and external comparators are appropriate to support regulatory decision-making
- Describe methodological approaches for improving the usefulness of RWD to aid in interpreting the safety and efficacy of medicines under development
- Propose mechanisms to integrate RWD into expediated drug development studies intended for regulatory submission
Speaker(s)
Innovative Approaches to External Controls; Synthetic Control Arms
Ruthie Davi, PhD, MS
Medidata, a Dassault Systèmes Company, United States
Vice President, Data Science and Statistician
Design and Analysis Approaches to Maximize the Validity of ECAs
Jeremy A Rassen, DrSc, MS
Aetion, United States
Co-Founder and President
Building Quality and Traceability into Data Curation
Zoe Li, MBA
COTA, United States
Director, Life Sciences
Using Comparators for Context: Key Points and Case Examples
Christina Mack, PhD, MPH
IQVIA, United States
Chief Scientific Officer, Real-World Solutions
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