IDEAL
Integrated DEsign and AnaLysis of small population group trials
| Coordinatore | UNIVERSITAETSKLINIKUM AACHEN
Organization address
address: Pauwelsstrasse 30 contact info |
| Nazionalità Coordinatore | Germany [DE] |
| Totale costo | 3˙648˙320 € |
| EC contributo | 2˙958˙449 € |
| 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) | 2013-11-01 - 2016-10-31 |
Partecipanti
| # | ||||
|---|---|---|---|---|
| 1 |
UNIVERSITAETSKLINIKUM AACHEN
Organization address
address: Pauwelsstrasse 30 contact info |
DE (AACHEN) | coordinator | 595˙400.00 |
| 2 |
MEDIZINISCHE UNIVERSITAET WIEN
Organization address
address: SPITALGASSE 23 contact info |
AT (WIEN) | participant | 466˙160.00 |
| 3 |
CHALMERS TEKNISKA HOEGSKOLA AB
Organization address
address: - contact info |
SE (GOETEBORG) | participant | 324˙416.00 |
| 4 |
UPPSALA UNIVERSITET
Organization address
address: SANKT OLOFSGATAN 10 B contact info |
SE (UPPSALA) | participant | 323˙424.00 |
| 5 |
RUHR-UNIVERSITAET BOCHUM
Organization address
address: Universitaetstrasse 150 contact info |
DE (BOCHUM) | participant | 294˙400.00 |
| 6 |
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)
Organization address
address: 101 Rue de Tolbiac contact info |
FR (PARIS) | participant | 262˙720.00 |
| 7 |
Luxembourg Institute of Health
Organization address
address: Val Fleuri 84 contact info |
LU (LUXEMBOURG) | participant | 199˙969.00 |
| 8 |
POLITECHNIKA WROCLAWSKA
Organization address
address: WYBRZEZE WYSPIANSKIEGO 27 contact info |
PL (WROCLAW) | participant | 197˙370.00 |
| 9 |
UNIVERSITEIT HASSELT
Organization address
address: MARTELARENLAAN 42 contact info |
BE (Hasselt) | participant | 183˙550.00 |
| 10 |
RHEINISCH-WESTFAELISCHE TECHNISCHE HOCHSCHULE AACHEN
Organization address
address: Templergraben 55 contact info |
DE (AACHEN) | participant | 111˙040.00 |
Mappa
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Obiettivo del progetto (Objective)
'There exist more than 7000 rare diseases worldwide and the European Society of Paediatric Oncology stated that 75% of rare diseases affect children and 30% of rare disease patients die before the age of five. Usual statistical methods for proving efficacy and safety of therapies fail to provide cost-efficient and reliable results in small populations. There is a pressing need to integrate a broad range of innovative methodologies improving clinical trials in the setting of small sample population groups (SPG). The objective of this research is to produce methods of general applicability irrespective of indication by Integrated DEsign and AnaLysis of clinical trials in SPG (IDEAL) through a multidisciplinary closely collaborating consortium of researchers from European universities, research institutes and industry. The consortium will work in 10 WPs, focussed on assessment of randomization procedures, extrapolating dose-response information, investigation of adaptive designs, optimal designs in mixed models, pharmacogenetic designs, simulation of clinical trials, genetic factors influencing the response, decision analysis and biomarker surrogate endpoints as well as WPs on project management and dissemination of results. Relevant stakeholder concerns (patient needs, regulatory issues, reimbursement, clinical feasibility) will be monitored by a Clinical Scientific Advisory Board. Because of its integrative structure, this research program extends previous approaches, which focus on a certain methodology only. In its totality, the WPs constitute a logically coherent set of methodologies that is of sufficient breadth to tackle these important, multidisciplinary challenges. By combining, enhancing and developing different statistical methodologies and assessment methods, this research program will impact the scientific discussion in promoting efficient statistical methodology for clinical trials in SPG, also in view of existing regulatory guidance in the EU.'