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Relating Expectations and needs to Participation and Empowerment of children in Clinical Trials

Objective

There are two objectives for this project, firstly to clarify the expectations and needs of children and their families who have participated or who might participate in clinical trials for new drugs in Europe. Secondly, to identify methods by which the expectations and needs can be translated into empowering and motivating participants in future clinical trails research. This will be achieved in three stages. The partners will be from different areas involving patients, clinicians, regulators, and researchers (industrial and academic) on a broad basis in order to cover a broad spectrum of diseases. Stage 1) The project will construct a basis for coordination and harmonization. This will involve a literature search and a preliminary workshop. We will build a web site for communication within the project and with a wider audience. Stage 2) We will ground our diverse experience and knowledge through benchmarking good practice case studies, and collecting opinions from patients’ organisations in Europe. The results will be presented at an expert harmonization workshop composed of all partners of the project. This workshop will identify the operating procedures needed to encourage empowerment and increase motivation for participation in clinical trials. Stage 3) The results of the project will be presented in a series of European conferences. This will ensure that the impact on clinical practice will be facilitated. This will help to improve translational research which depends upon the clinical trial process being undertaken with large enough populations to ensure safety of new products. Greater participation in clinical trials research will result in more valid and reliable products available for children as envisaged by the EC 1901/2006 Paediatric Regulation. In addition it will make European health businesses more competitive and will improve the global health in Europe.

Call for proposal

FP7-HEALTH-2007-A
See other projects for this call

Coordinator

GOETEBORGS UNIVERSITET
Address
Vasaparken
405 30 Goeteborg
Sweden
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 198 000
Administrative Contact
Margareta Ahlqwist (Dr.)

Participants (6)

UNIVERSITAETSKLINIKUM HAMBURG-EPPENDORF
Germany
EU contribution
€ 92 000
Address
Martinistrasse 52
20251 Hamburg
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Monika Bullinger (Prof.)
FORUM EUROPEEN DES PATIENTS (FPE)
Luxembourg
EU contribution
€ 72 000
Address
Rue Dicks 14
1417 Luxembourg
Activity type
Other
Administrative Contact
Nicola Bedlington (Ms.)
UNIVERZITETNI KLINICNI CENTER LJUBLJANA
Slovenia
EU contribution
€ 32 000
Address
Zaloska Cesta 002
1000 Ljubljana
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Darinka Miklavcic (Ms.)
GOOD CLINICAL PRACTICE ALLIANCE - EUROPE
Belgium
EU contribution
€ 42 000
Address
Rue Washington Straat 40
1050 Brussel
Activity type
Other
Administrative Contact
Francis P. Crawley (Mr.)
CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE
Italy
EU contribution
€ 32 000
Address
Via Nicolo Putignani 178
70122 Bari
Activity type
Research Organisations
Administrative Contact
Adriana Ceci (Prof.)
AZIENDA OSPEDALE-UNIVERSITÀ PADOVA
Italy
EU contribution
€ 32 000
Address
Via Nicolo Giustiniani 1
35128 Padova
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Antonio Giona (Dr.)