INSPIRE
Innovative methodology for small populations research
| Coordinatore | THE UNIVERSITY OF WARWICK
Organization address
address: Kirby Corner Road - University House - contact info |
| Nazionalità Coordinatore | United Kingdom [UK] |
| Totale costo | 2˙919˙912 € |
| EC contributo | 2˙268˙504 € |
| Programma | FP7-HEALTH
Specific Programme "Cooperation": Health |
| Code Call | FP7-HEALTH-2013-INNOVATION-1 |
| Funding Scheme | CP-FP |
| Anno di inizio | 2014 |
| Periodo (anno-mese-giorno) | 2014-02-01 - 2017-05-31 |
Partecipanti
| # | ||||
|---|---|---|---|---|
| 1 |
THE UNIVERSITY OF WARWICK
Organization address
address: Kirby Corner Road - University House - contact info |
UK (COVENTRY) | coordinator | 814˙478.90 |
| 2 |
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)
Organization address
address: 101 Rue de Tolbiac contact info |
FR (PARIS) | participant | 466˙608.80 |
| 3 |
MEDIZINISCHE UNIVERSITAET WIEN
Organization address
address: SPITALGASSE 23 contact info |
AT (WIEN) | participant | 423˙809.20 |
| 4 |
UNIVERSITAETSMEDIZIN GOETTINGEN - GEORG-AUGUST-UNIVERSITAET GOETTINGEN - STIFTUNG OEFFENTLICHEN RECHTS
Organization address
address: Robert-Koch-Strasse 40 contact info |
DE (GOETTINGEN) | participant | 385˙732.80 |
| 5 |
CLINICAL TRIALS CONSULTING & TRAINING LIMITED
Organization address
address: Portway 53 contact info |
UK (North Marston) | participant | 54˙521.95 |
| 6 |
STOCKHOLMS UNIVERSITET
Organization address
address: Universitetsvaegen 10 contact info |
SE (STOCKHOLM) | participant | 50˙680.00 |
| 7 |
BUNDESINSTITUT FUR ARZNEIMITTEL UND MEDIZINPRODUKTE
Organization address
address: KURT GEORG KIESINGER ALLEE 3 contact info |
DE (BONN) | participant | 48˙647.00 |
| 8 |
QUINTILES LTD
Organization address
address: MARKET STREET STATION HOUSE contact info |
UK (BRACKNELL) | participant | 24˙026.00 |
Mappa
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Obiettivo del progetto (Objective)
'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.'