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Session 4: Innovative Approaches and Considerations for Use of External Controls in Drug Development
Session Chair(s)
Gillis Carrigan, PhD, MS
Director, Center for Observational Research, Amgen, United States
Interest is growing in innovative uses of external control arms (ECAs) in drug development, as reflected in recent global regulatory guidance on the role of real-world evidence (RWE) in regulatory decision-making. This session will highlight current research in this dynamic and rapidly evolving area of drug development and RWE.
The session will examine the current role of external controls in drug development and regulatory decision-making. It will begin with a brief overview of this evolving RWE use case, followed by an oncology case study, considerations for selecting appropriate data sources, and a discussion of AI-derived digital twins as external controls. Key takeaways will inform a roundtable discussion and give attendees an opportunity to participate.
Learning Objective : By the end of this session, participants should be able to: - Describe key challenges in conducting ECA studies and strategies for addressing them during study design
- Explain why fit-for-purpose data are foundational for ECA use cases
- Discuss how innovative approaches, such as digital twins, can support efficient clinical trial design and offer an alternative to traditional ECAs
Speaker(s)
Externally Controlled Trials Using Real-World Data: Adapting SPIFD2 to Ensure Principled Design and Data Selection (SPIFD-ECT)
Ulka Campbell, PhD
Head of Scientific Strategy, Datavant, United States
Advancing External Control Arms for Regulatory Use: Lessons from a Multi-Stakeholder Pilot
Bernat Navarro, PhD
Senior Science Policy Analyst, Friends of Cancer Research, United States
Digital Twins as Synthetic Controls for Single-Arm Trials
Daniele Bertolini, PhD, MS
Principal Machine Learning Scientist, Unlearn.AI, United States
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