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Innovative methodology for small populations research

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.

Invito a presentare proposte

FP7-HEALTH-2013-INNOVATION-1
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Coordinatore

THE UNIVERSITY OF WARWICK
Indirizzo
Kirby Corner Road - University House
CV4 8UW Coventry
United Kingdom

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Tipo di attività
Higher or Secondary Education Establishments
Contatto amministrativo
Nigel Stallard (Prof.)
Contributo UE
€ 814 478,86

Partecipanti (7)

UNIVERSITAETSMEDIZIN GOETTINGEN - GEORG-AUGUST-UNIVERSITAET GOETTINGEN - STIFTUNG OEFFENTLICHEN RECHTS
Germania
Contributo UE
€ 385 732,80
Indirizzo
Robert-koch-strasse 40
37075 Goettingen

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Tipo di attività
Higher or Secondary Education Establishments
Contatto amministrativo
Christiane Hennecke (Mrs.)
MEDIZINISCHE UNIVERSITAET WIEN
Austria
Contributo UE
€ 423 809,20
Indirizzo
Spitalgasse 23
1090 Wien

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Tipo di attività
Higher or Secondary Education Establishments
Contatto amministrativo
Wolfgang Dorda (Prof.)
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
Francia
Contributo UE
€ 466 608,80
Indirizzo
Rue De Tolbiac 101
75654 Paris

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Tipo di attività
Research Organisations
Contatto amministrativo
Isabelle Verdier (Mrs.)
BUNDESINSTITUT FUR ARZNEIMITTEL UND MEDIZINPRODUKTE
Germania
Contributo UE
€ 48 647
Indirizzo
Kurt Georg Kiesinger Allee 3
53175 Bonn

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Tipo di attività
Research Organisations
Contatto amministrativo
Sandra Ludwig-Merseburg
STOCKHOLMS UNIVERSITET
Svezia
Contributo UE
€ 50 680
Indirizzo
Universitetsvagen 10
10691 Stockholm

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Tipo di attività
Higher or Secondary Education Establishments
Contatto amministrativo
Ulla Jungmarker (Mrs.)
QUINTILES LIMITED
United Kingdom
Contributo UE
€ 24 026
Indirizzo
500 Brook Drive, Green Park, Berkshire
RG2 6UU Reading

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Tipo di attività
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Contatto amministrativo
Alex Dmitrienko (Dr.)
CLINICAL TRIALS CONSULTING & TRAINING LIMITED
United Kingdom
Contributo UE
€ 54 521,95
Indirizzo
Portway 53
MK18 3PL North Marston

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Tipo di attività
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Contatto amministrativo
Simon Day (Dr.)