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The Project - European HD Network |
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What is the European HD Network about?
- The European HD Network
should provide a platform for professionals and people affected by HD and their
relatives to facilitate working together throughout Europe
- The European HD Network
should facilitate natural history studies and interventional trials meeting
high standards (‘Good Clinical Practice’ = GCP) thus helping on the road
towards a cure of HD
- The European HD Network
should be a true network in that all participants involved can take a lead and
propose, conduct and publish studies
How did the idea of a European HD Network come about?
- An interventional trial testing Riluzole in more than 500 patients
in early stages of HD in 9 countries throughout Europe (‘European
Huntington Disease Initiative’ = EHDI-Trial) demonstrated that large
scale studies on HD can be done in Europe
- Since the EHDI-Trial calls for an observation period of 3 year and
the last patients will have completed their observation period end of
April 2004, an infrastructure for clinical trials on HD in Europe
independent of a specific industrial sponsor was highly desired
- A private American Foundation, the High-Q Foundation, decided to sponsor ‚The Huntington Project‘, a 10-year endeavour to speed up the process of finding ways to improve the natural course of HD
- The idea of an Euro-HD Network was kickstarted at the Gordon Research Conference at Il Ciocco, Tuscany, in May 2003
Who finances the European HD Network?
- A private American Foundation, High-Q, in the context of sponsoring 'The Huntington Project', a 10-year endeavor
How is the European HD Network organized?
- Study sites
- Working groups
- Coordination centres organized according to language
- Central coordination including information technology (IT) core facility
- Executive Committee
- Scientific and Bioethics Advisory Committee
| | What does the European HD Network provide?
- An infrastructure for large scale clinical trials on HD throughout Europe (database, IT-tools, monitoring personal etc.)
- An IT platform for communication tools (in the respective native languages) and e-trials
- A forum for close cooperation of basic scientists and clinicians
- Low threshold (native language!) support for study sites by language group coordinators
What does the European HD Network NOT provide?
- Funding for individual projects
- But: in case of approval of an application by the Board of
Directors a letter of support specifying the resources of
European HD Network made available to the project will be provided thus
making funding through national or international funding organisations
(EU, HDF, High-Q etc) more likely
First Steps ...
- Set up IT and get approval by data security authorities throughout Europe
- Set up coordination centres
- Start up core study REGISTRY at all sites
- Start up defined, sponsored studies at selected sites
- European extension of PREDICT - Euro-HD-Transplant-2 - Phase 2 studies of promising compounds |
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