Use of external data to augment clinical trials has been increasingly evaluated and is transforming drug development paradigms.
Numerous innovative methods including hybrid designs, Bayesian borrowing and disease modeling have been developed, raising the new regulatory question: “Is the data we observe similar to the data we predicted or intended to include?”
The webinar will describe the latest methodological developments across these areas; depict their current and upcoming impact, and discuss how it is transforming drug development.
Speakers:
- Cécile Ollivier, Vice President of Global Affairs at C-Path
- Dr Andrew Thomson, Consultant
- Billy Amzal, Head of Strategic Consulting
Learning Points:
- How to address small populations and pediatric extrapolations by using external data.
- How reference and regulatory grade disease modeling is transforming drug development.
- Which data extrapolation and augmentation methods to use? Which data to use?
