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Financement de l’UE (4 788 834 €) : Des données probantes du monde réel à l’appui des décisions en matière de diabète Hor28/11/2022 Programme de recherche et d'innovation de l'UE « Horizon »
Texte
Des données probantes du monde réel à l’appui des décisions en matière de diabète
Randomised controlled trials are the cornerstone of evidence-based medicine. However, the digitisation of real-world data (RWD) including data from devices, wearables, and electronic health records in large national registries provides opportunities to demonstrate efficacy and safety of innovative technologies including drugs, devices, diagnostics, and digital health. These data are particularly relevant to long-term conditions such as diabetes mellitus, where drugs, lifestyle interventions, and digital technologies often work together. To better utilise RWD in diabetes for regulatory decision making, a development of standards, guidance, and an assessment of the efficacy to effectiveness gap is needed. REDDIE (Real-World Evidence for Decisions in Diabetes) aims to explore how RWD can complement RCTs to improve efficacy, safety, and value for money of technologies to prevent and treat diabetes. The overall aim of REDDIE is to support the use of RWD in diabetes and health-related research, which will maximise Europe’s scientific expertise and know-how to benefit people with diabetes, resulting in safer, more efficient, and cost-effective interventions. We thus aim to engage with stakeholders such as regulatory and HTA authorities and co-develop evidentiary standards for the collection, assessment, and acceptability of RWD. We will then develop and validate state-of-the art modelling techniques using synthetic data derived from large national registries to better assess outcomes of interventions using RWD. We will use data from four large national registries to elucidate the gap between outcomes in RCTs and RWD studies, and understand the factors that affect this gap. Finally, we will test the ability of machine learning to facilitate the better use of RWD. REDDIE will generate standards for RWD use for the evaluation of medicines and other interventions by regulatory authorities and HTA bodies.
| Breakthrough T1D | ? |
| Eurice European Research AND Project Office GmbH | 479 875 € |
| Goeteborgs Universitet | 522 189 € |
| Laegemiddelstyrelsen | 352 500 € |
| Medizinische Universitat Graz | 943 750 € |
| Novo Nordisk A/S | 150 000 € |
| Region Hovedstaden | 963 750 € |
| Research AND Innovation Services d.o.o. | 0,00 € |
| Stichting Radboud Universitair Medisch Centrum | 100 000 € |
| Universita Degli Studi Di Padova | 749 880 € |
| Universitaet ULM | 526 890 € |
https://cordis.europa.eu/project/id/101095556
Cette annonce se réfère à une date antérieure et ne reflète pas nécessairement l’état actuel. L’état actuel est présenté à la page suivante : JDRF Non profit corporation, City of New York, États-Unis.