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: from Jan 2024

PARTNERS:

• Fondazione per la Ricerca Farmacologica Gianni Benzi - ETS, Italy
• INSERM – INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE, France
• UU – UPPSALA UNIVERSITET, Sweden
• MUW – MEDIZINISCHE UNIVERSITÄT WIEN, Austria
• HDH – PLATEFORME DES DONNEES DE SANTE, France
• TEDDY – EUROPEAN NETWORK OF EXCELLENCE FOR PEDIATRIC CLINICAL RESEARCH, Italy
• MUNI – MASARYKOVA UNIVERZITA, Czechia
• MPA – LÄKEMEDELSVERKET, Sweden
• ROCHE – F. HOFFMANN-LA ROCHE AG, Switzerland
• RUMC – STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM, Netherlands
• UMG – UNIVERSITY MEDICAL CENTER GÖTTINGEN, Germany
• AP-HP – ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS, France
• PMX – PHARMETHEUS AB, Sweden
• ECRIN – EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK, France
• IT – INSERM TRANSFERT, France
• NOVARTIS – NOVARTIS PHARMA AG, Switzerland