Obiettivo The HEALTH.2013.4.2-3 call identifies a need for new or improved statistical methodology for clinical trials for the efficient assessment of safety and/or efficacy of treatment for small population groups. This project brings together international experts in innovative clinical trial design methodology in these specific areas along with key stakeholders including regulatory authorities, industry, clinicians and patient groups to address this need. Our aim is the development novel methodology for the design and analysis of clinical trials in small populations. We will focus on four specific areas where we believe there are particular challenges: (i) early phase dose-finding studies in small populations, (ii) decision-theoretic methods for clinical trials in small populations, (iii) confirmatory trials in small populations and personalised medicines, (iv) use of evidence synthesis in the planning and interpretation of clinical trials in small populations and rare diseases.We will build on recent research advances, of our own and of others in this area. In the rare disease setting, we will focus on Bayesian and decision-theoretic methods that formally enable comparison of the gain in information with the cost, both in economic and opportunity terms, of clinical experimentation, and assess how information from outside the trial can formally be incorporated in the design and decision-making processes. In the personalised medicine setting, we will develop methods that allow evaluation of efficacy in a number of sub-populations simultaneously in a confirmatory clinical trial without any reduction in scientific or statistical rigour. Campo scientifico medical and health scienceshealth sciencespersonalized medicine Programma(i) FP7-HEALTH - Specific Programme "Cooperation": Health Argomento(i) HEALTH.2013.4.2-3 - New methodologies for clinical trials for small population groups Invito a presentare proposte FP7-HEALTH-2013-INNOVATION-1 Vedi altri progetti per questo bando Meccanismo di finanziamento CP-FP - Small or medium-scale focused research project Coordinatore UNIVERSITY OF WARWICK Contributo UE € 814 478,86 Indirizzo KIRBY CORNER ROAD UNIVERSITY HOUSE CV4 8UW COVENTRY Regno Unito Mostra sulla mappa Regione West Midlands (England) West Midlands Coventry Tipo di attività Higher or Secondary Education Establishments Contatto amministrativo Nigel Stallard (Prof.) Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Costo totale Nessun dato Partecipanti (7) Classifica in ordine alfabetico Classifica per Contributo UE Espandi tutto Riduci tutto UNIVERSITAETSMEDIZIN GOETTINGEN - GEORG-AUGUST-UNIVERSITAET GOETTINGEN - STIFTUNG OEFFENTLICHEN RECHTS Germania Contributo UE € 385 732,80 Indirizzo Robert-Koch-Strasse 40 37075 Goettingen Mostra sulla mappa Regione Niedersachsen Braunschweig Göttingen Tipo di attività Higher or Secondary Education Establishments Contatto amministrativo Christiane Hennecke (Mrs.) Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Costo totale Nessun dato MEDIZINISCHE UNIVERSITAET WIEN Austria Contributo UE € 423 809,20 Indirizzo SPITALGASSE 23 1090 Wien Mostra sulla mappa Regione Ostösterreich Wien Wien Tipo di attività Higher or Secondary Education Establishments Contatto amministrativo Wolfgang Dorda (Prof.) Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Costo totale Nessun dato INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE Francia Contributo UE € 466 608,80 Indirizzo RUE DE TOLBIAC 101 75654 Paris Mostra sulla mappa Regione Ile-de-France Ile-de-France Paris Tipo di attività Research Organisations Contatto amministrativo Isabelle Verdier (Mrs.) Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Costo totale Nessun dato BUNDESINSTITUT FUR ARZNEIMITTEL UND MEDIZINPRODUKTE Germania Contributo UE € 48 647,00 Indirizzo KURT GEORG KIESINGER ALLEE 3 53175 Bonn Mostra sulla mappa Regione Nordrhein-Westfalen Köln Bonn, Kreisfreie Stadt Tipo di attività Research Organisations Contatto amministrativo Sandra Ludwig-Merseburg Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Costo totale Nessun dato STOCKHOLMS UNIVERSITET Svezia Contributo UE € 50 680,00 Indirizzo UNIVERSITETSVAGEN 10 10691 Stockholm Mostra sulla mappa Regione Östra Sverige Stockholm Stockholms län Tipo di attività Higher or Secondary Education Establishments Contatto amministrativo Ulla Jungmarker (Mrs.) Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Costo totale Nessun dato QUINTILES LIMITED Regno Unito Contributo UE € 24 026,00 Indirizzo 500 BROOK DRIVE, GREEN PARK, BERKSHIRE RG2 6UU READING Mostra sulla mappa Regione South East (England) Berkshire, Buckinghamshire and Oxfordshire Berkshire Tipo di attività Private for-profit entities (excluding Higher or Secondary Education Establishments) Contatto amministrativo Alex Dmitrienko (Dr.) Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Costo totale Nessun dato CLINICAL TRIALS CONSULTING & TRAINING LIMITED Regno Unito Contributo UE € 54 521,95 Indirizzo Portway 53 MK18 3PL North Marston Mostra sulla mappa Regione South East (England) Berkshire, Buckinghamshire and Oxfordshire Buckinghamshire CC Tipo di attività Private for-profit entities (excluding Higher or Secondary Education Establishments) Contatto amministrativo Simon Day (Dr.) Collegamenti Contatta l’organizzazione Opens in new window Sito web Opens in new window Costo totale Nessun dato