INVENTS - Innovative designs, extrapolation, simulation methods and evidence-tools for rare diseases addressing regulatory needs

Department of Medical Statistics

The overall objective of INVENTS is to provide clinical trial stakeholders, trialists and regulators with a generalisable framework encompassing methods, workflows and evidence-tools to improve the level of evidence in regulatory decision making in rare diseases.
This will be achieved through the development and validation of improved extrapolation models, simulation and in silico trials, model based clinical trial design and evidence synthesis methods, all based on robust and mature computational models and qualified on extensive data from representative selected use cases.

The project is funded under Horizon Europe framework program and brings together 15 partners from 9 countries.
The Department of Medical Statistics is involved with a work package lead to deepen the understanding of how information originating from very different data sources should be synthesised, in particular, when in silico trials generating virtual patients and cohorts are involved. This includes the development of models, as well as criteria to assess such methods and the derived inferences. The work is motivated and illustrated by several drug development applications.

Involved scientists from the Department of Medical Statistics

Prof. Tim Friede
Head of the Department of Medical Statistics

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Institutsdirektor

Univ.-Prof. Dr. Tim Friede

Univ.-Prof. Dr. Tim Friede

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