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Innovative methodology for small populations research

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 tog... see more

31/05/2017

UNIVERSITY OF WARW...

3M€

Project Budget: 3M€

Project leader

UNIVERSITY OF WARWICK No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

PARTICIPATION DEPralty Sin fecha límite de participación.

Ver 8 Participantes

Financing granted El organismo FP7 notifico la concesión del proyecto The day 2017-05-31 We do not have the information of the call

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characteristics of the participant

Este proyecto no cuenta con búsquedas de partenariado abiertas en este momento.

Private Information

No hay información privada compartida para este proyecto. Habla con el coordinador.

8 Participantes

UNIVERSITY OF WARWICK

0.00€ | Leader

BUNDESINSTITUT FUR ARZNEIMIT...

N.D. | participant

UMG

N.D. | participant

STOCKHOLMS UNIVERSITET

N.D. | participant

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Project leader

UNIVERSITY OF WARWICK No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Project Budget 3M€

participation deadline Sin fecha límite de participación.

Project description 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.

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