The project aims to provide clinical trial trialists, researchers and regulators with a global framework encompassing methods, workflows and evidence assessment tools to be implemented in orphan and paediatric drug development. Refined longitudinal model-based diseases trajectories and treatment effect, improved extrapolation models, in silico trials (e.g., virtual patient cohorts), optimised model-based clinical trial designs and evidence synthesis methods will be developed and validated. INVENTS will improve the evaluation of evidence and regulatory credibility of these methodologies.

ROLE OF THE FOUNDATION
The Foundation is involved in the ethics and regulatory activities of the project, in the Advisory Regulatory Ethics Board and in the integration of patient experiences into regulatory decision making. This contributes to appropriately address ethics and regulatory issues and ensure the continuous and careful update of these aspects in the project.

FUNDED BY: Horizon Europe–Health, GA 101136365, 2024-28 (www.cordis.europa.eu/project/id/101136365/pl)

DURATION: January 2024- December 2028 

PARTNERS:

• INSERM – INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE, France (coordinator)
• AP-HP – Assistance Publique Hôpitaux de Paris, France
• ECRIN – European Clinical Research Infrastructure Network, France
• Fondazione per la Ricerca Farmacologica Gianni Benzi - ETS, Italy
• HDH – Plateforme des Donnees de Sante, France
• IT – Inserm Transfert, France
• MPA – Läkemedelsverket, Sweden
• MUNI – Masarykova Univerzita, Czechia
• MUW – Medizinische Universität Wien, Austria
• NOVARTIS – Novartis Pharma AG, Switzerland
• PMX – Pharmetheus AB, Sweden
• ROCHE – F. Hoffmann-La Roche AG, Switzerland
• RUMC – Stichting Radboud Universitair Medisch Centrum, Netherlands
• TEDDY – European Network of Excellence for Pediatric Clinical Research, Italy
• UMG – University Medical Center Göttingen, Germany
• UU – Uppsala Universitet, Sweden