Objectif "ASTERIX will contribute towards the expected impact listed in the work program by delivering validated innovative statistical design methodologies for cost efficient clinical trials deriving reliable results from trials in small population groups, especially focusing on rare diseases. It directly addresses the rights of the estimated 30 million European patients suffering from rare diseases to the same quality or treatment as other patients. By choosing an integrated approach leveraging statistical methods, smartly combining observational and clinical data as well as improved sequential and adaptive approaches ASTERIX will improve statistical power of clinical trial design in small populations. ASTERIX will systematically include patients and the patient perspective into its research, but moreover develop the approach to involve patients in clinical trial design in a methodological sound manner. Pre-clinical data, historical data on disease characteristics, and benefit and risk as perceived by patients will systematically inform and weigh relevant endpoint measures. Thus the clinical value of trial results will be enhanced considerably. Key methodological innovations include: new standards of evidence that take into account the rare prevalence of disease, leveraging prior information and the availability of multiple endpoints, enabling adaptive designs and sequential meta-analysis using multiple endpoints and providing a blue print to pro-actively share information on trials in the planning stage. The latter will ensure that each new trial in an orphan disease provides the optimum additional knowledge for patient treatment. Relevance and clinical value of the newly designed methodological approaches are validated twofold. Firstly, by cross testing with available clinical trial data of a broad range of highly relevant rare diseases and secondly, by assessing the methods against current and improved regulatory approval strategies." Programme(s) FP7-HEALTH - Specific Programme "Cooperation": Health Thème(s) HEALTH.2013.4.2-3 - New methodologies for clinical trials for small population groups Appel à propositions FP7-HEALTH-2013-INNOVATION-1 Voir d’autres projets de cet appel Régime de financement CP-FP - Small or medium-scale focused research project Coordinateur UNIVERSITAIR MEDISCH CENTRUM UTRECHT Contribution de l’UE € 750 058,00 Adresse HEIDELBERGLAAN 100 3584 CX Utrecht Pays-Bas Voir sur la carte Région West-Nederland Utrecht Utrecht Type d’activité Higher or Secondary Education Establishments Contact administratif Caroline Van Baal (Dr.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée Participants (6) Trier par ordre alphabétique Trier par contribution de l’UE Tout développer Tout réduire MEDIZINISCHE HOCHSCHULE HANNOVER Allemagne Contribution de l’UE € 525 200,00 Adresse Carl-Neuberg-Strasse 1 30625 Hannover Voir sur la carte Région Niedersachsen Hannover Region Hannover Type d’activité Higher or Secondary Education Establishments Contact administratif Frank Dittrich (Mr.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée MEDIZINISCHE UNIVERSITAET WIEN Autriche Contribution de l’UE € 515 401,00 Adresse SPITALGASSE 23 1090 Wien Voir sur la carte Région Ostösterreich Wien Wien Type d’activité Higher or Secondary Education Establishments Contact administratif Wolfgang Dorda (Prof.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée ACADEMISCH MEDISCH CENTRUM BIJ DE UNIVERSITEIT VAN AMSTERDAM Pays-Bas Contribution de l’UE € 466 640,00 Adresse MEIBERGDREEF 15 1105AZ Amsterdam Voir sur la carte Région West-Nederland Noord-Holland Groot-Amsterdam Type d’activité Higher or Secondary Education Establishments Contact administratif Sylvia Georgiev (Ms.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée UNIVERSITAT AUTONOMA DE BARCELONA Espagne Contribution de l’UE € 512 442,00 Adresse EDIF A CAMPUS DE LA UAB BELLATERRA CERDANYOLA V 08193 Cerdanyola Del Valles Voir sur la carte Région Este Cataluña Barcelona Type d’activité Higher or Secondary Education Establishments Contact administratif Francisca Rabadán Sotos (Ms.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée STATISTICIANS IN THE PHARMACEUTICALINDUSTRY LIMITED LBG Royaume-Uni Contribution de l’UE € 68 150,00 Adresse DURFORD MILL GU31 5AZ PETERSFIELD Voir sur la carte Type d’activité Private for-profit entities (excluding Higher or Secondary Education Establishments) Contact administratif Alun Bedding (Mr.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée VERENIGING SAMENWERKENDE OUDER- EN PATIENTENORGANISATIES Pays-Bas Contribution de l’UE € 161 990,00 Adresse Vredehofstraat 31 3761HA SOEST Voir sur la carte Région West-Nederland Utrecht Utrecht Type d’activité Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Contact administratif Cor Oosterwijk (Mr.) Liens Contacter l’organisation Opens in new window Site web Opens in new window Coût total Aucune donnée
