Parallel session 10.00 - 12.00
Extrapolation in Regulatory Science: Smarter use of available data
Chair: Bert Leufkens, Lygature; Utrecht University, Professor of Pharmaceutical Policy and Regulatory Science
In the coming decades, so-called precision treatments aimed at relatively small and well-defined patient populations will impact current methods of data collection. This will, on the one hand, increase the need for extrapolation to different patient populations, clinical settings or development stages and, on the other hand, allow for more refined extrapolation methods that exploit available data more effectively.
These new extrapolation methods may play an important role in approaches for regulatory assessments, Health Technology Assessments (HTA) and clinical use. In this session we will explore the perspectives and experiences from different stakeholders on how extrapolation in clinical drug development, regulation, HTA and clinical practice is currently applied, and which challenges we may face with regard to acceptance of novel methods for extrapolation.
- Kit Roes, Julius Center, UMC Utrecht, Professor Clinical Trial Methodology
- Wim Goettsch, Zorginstituut Nederland
- Saskia de Wildt, Radboud UMC, Nijmegen, Paediatric Intensivist and Professor of Clinical Pharmacology