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