ASTERIX

Advances in Small Trials dEsign for Regulatory Innovation and eXcellence

Coordinatore	UNIVERSITAIR MEDISCH CENTRUM UTRECHT    more  Organization address address: HEIDELBERGLAAN 100 city: UTRECHT postcode: 3584 CX contact info Titolo: Dr. Nome: Caroline Cognome: Van Baal Email: send email Telefono: +31 88759394
Nazionalità Coordinatore	Netherlands [NL]
Totale costo	4˙141˙786 €
EC contributo	2˙999˙881 €
Programma	FP7-HEALTH Specific Programme "Cooperation": Health
Code Call	FP7-HEALTH-2013-INNOVATION-1
Funding Scheme	CP-FP
Anno di inizio	2013
Periodo (anno-mese-giorno)	2013-10-01   -   2017-09-30

 Partecipanti

#	participant	country	role	EC contrib. [€]
1	UNIVERSITAIR MEDISCH CENTRUM UTRECHT  Organization address address: HEIDELBERGLAAN 100 city: UTRECHT postcode: 3584 CX contact info Titolo: Dr. Nome: Caroline Cognome: Van Baal Email: send email Telefono: +31 88759394	NL (UTRECHT)	coordinator	750˙058.00
2	MEDIZINISCHE HOCHSCHULE HANNOVER  Organization address address: Carl-Neuberg-Strasse 1 city: HANNOVER postcode: 30625 contact info Titolo: Mr. Nome: Frank Cognome: Dittrich Email: send email Telefono: +49 5115325343	DE (HANNOVER)	participant	525˙200.00
3	MEDIZINISCHE UNIVERSITAET WIEN  Organization address address: SPITALGASSE 23 city: WIEN postcode: 1090 contact info Titolo: Prof. Nome: Wolfgang Cognome: Dorda Email: send email Telefono: +43 1404006699 Fax: +43 1 404006601	AT (WIEN)	participant	515˙401.00
4	UNIVERSITAT AUTONOMA DE BARCELONA  Organization address address: Campus UAB -BELLATERRA- s/n city: CERDANYOLA DEL VALLES postcode: 8193 contact info Titolo: Ms. Nome: Francisca Cognome: Rabadán Sotos Email: send email Telefono: +34 93 5813752 Fax: +34 93 5814152	ES (CERDANYOLA DEL VALLES)	participant	512˙442.00
5	Academisch Medisch Centrum bij de Universiteit van Amsterdam  Organization address address: MEIBERGDREEF 9 city: AMSTERDAM postcode: 1105AZ contact info Titolo: Ms. Nome: Sylvia Cognome: Georgiev Email: send email Telefono: +31 205666505	NL (AMSTERDAM)	participant	466˙640.00
6	VERENIGING SAMENWERKENDE OUDER- EN PATIENTENORGANISATIES  Organization address address: Vredehofstraat 31 city: SOEST postcode: 3761HA contact info Titolo: Mr. Nome: Cor Cognome: Oosterwijk Email: send email Telefono: +31 035 603 4040	NL (SOEST)	participant	161˙990.00
7	STATISTICIANS IN THE PHARMACEUTICALINDUSTRY LIMITED LBG  Organization address address: DURFORD MILL city: PETERSFIELD postcode: GU31 5AZ contact info Titolo: Mr. Nome: Alun Cognome: Bedding Email: send email Telefono: +44 1438 766604	UK (PETERSFIELD)	participant	68˙150.00

Mappa

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 Obiettivo del progetto (Objective)

'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.'