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HD research news - medical research into treatment & prevention The Euro-HD Network: the role of the UKSeptember 2006What is the Euro-HD Network? The Euro-HD Network aims to provide a platform for professionals and people affected by HD (and their relatives) wishing to work together. It aims to facilitate natural history studies and interventional trials throughout Europe that meet Good Clinical Practise standards and help in the search for treatments and a cure for HD. A key element of the network is that all centres involved throughout Europe can take a lead, propose, conduct and publish studies. The Euro-HD Network is committed to working with all Huntington’s disease associations. Contact has been made with the HDA for England and Wales, the Scottish Huntington’s Association, Northern Ireland Huntington’s Disease Association and the Huntington’s disease Association of Ireland. Each of these associations has invited representatives from Euro-HD to meet members and talk about the Network and send delegates to the annual meetings. How did the idea of a Euro-HD Network come about? A drug interventional trial testing Riluzole (a motor sedative) 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 conducted in Europe. Since the EHDI-Trial used an observation period of 3 years and the last patients completed their observation period at the end of April 2004, an independent infrastructure for clinical trials on HD in Europe became highly desirable. Who finances the Euro-HD Network?
A private American Foundation, the High-Q Foundation, has initiated and funded ‘The Huntington Project’, a 10-year endeavour to speed up the process of finding ways to improve the natural course of HD. The High Q Foundation, founded in 2002, is a private charitable foundation dedicated to finding therapies for Huntington's disease. It operates as a non-profit organisation devoted to drug discovery and development for HD. Over the past seven years the High Q Foundation and its affiliates have donated more than $50 million to HD research, both directly and through organizations such as the Hereditary Disease Foundation (HDF), Huntington's Disease Society of America (HDSA), and the Huntington Study Group (HSG). Now High Q has established an independent presence in order to bring together academia, industry, government agencies, and other funding organisations to accelerate the search for HD therapies and treatments. How is the Euro-HD Network organized? Central coordination is based a the University of Ulm, Germany. The CEO (Professor Bernhard Landwehrmeyer) and his team of medical staff, administrators, and IT specialists make up the core structure of the Euro-HD Network. Central coordination also hosts the web server. The server is in a secure location and is protected from public access. Coordination centres are located in the following European countries: Germany (Ulm), UK & Ireland (Cardiff), Netherlands (Leiden), Spain (Madrid), Italy (Milan), Scandinavia (Oslo) and France (Paris). These coordination centres are organised according to language, therefore we have German, English, Italian, Spanish and French speaking coordinators. Each language coordinator disseminates information to, and answers queries from the study sites in their country. The English-speaking co-ordinators are Dr. Jenny Naji and Dr. Olivia Handley, based in Cardiff. Part of their role is to work closely with each of the UK centres involved the network. So far, Jenny and Olivia have visited all of the UK study sites (listed in Figure 1) and are in the process of encouraging more sites from around the UK and Ireland to join the network. Since the Euro-HD Network is web-based all of the study sites have had training on how to use the website. Since pseudonymised (i.e. a patient’s personal details are replaced with a code) patient information is entered onto the website, it is essential that each site knows how to manage this information and maintain accurate clinical and research records.
An additional role of the UK language coordinators includes communicating information from central coordination to each UK study site. Every few months, coordinator meetings are held in one of the respective countries. At these meetings language co-ordinators are updated about the progress in each of the countries. Discussions are held about recent developments with the website and the network, issues and problems are raised together with suggested solutions. Study sites are HD centres or clinics that provide standardised clinical assessments for Huntington’s disease (based around the Unified Huntington’s Disease Rating Scale, UHDRS). At the beginning of the Euro-HD initiative there were 12 study sites in the UK and Ireland and there are now 22 sites. A number of these study sites have strong connections with research programs, for example, the HD transplant trial in the UK. Working groups encourage professionals sharing common interests in HD to work together. A broad range of working groups are already established, including novel assessment tools for HD, juvenile HD and neuroprotective therapies for HD. The Euro-HD Network invites clinical, scientific and lay members to join these working groups in order to facilitate collaborations and novel research. UK study sites involved in the Euro-HD Network The Board of Directors (BoD) is a committee made up of number of scientific and clinical experts in HD. The BoD helps to direct and develop the structure and role of the network. The Scientific Advisory Board is a committee focused on reviewing research proposals based around the Euro-HD Network database. A written outline is sent to the Advisory Board who offer feedback on scientific merit, feasibility and funding issues. What is the Registry Study? The Registry study is the core study for the Euro-HD Network. Each study site from around Europe invites patients with HD if they would like to participate in Registry. Once consent is obtained from a patient, a team of clinicians and HD specialists will ask the patient and their carer to take part in a number of clinical assessments and questionnaires. Many of these assessments are already conducted as part of the existing clinic service in the majority of the sites around Europe. One major issue for any study of this nature is data security, i.e., protecting a patient’s identity. Only once strict guidelines have been met and approved can data be entered onto the website. It is not possible for anyone other than authorised individuals to view information about any individual taking part in the Registry study. Part of ensuring data security is made possible through coding a patient’s personal details as a pseudonym (a unique 9-digit code created through a highly sophisticated and unbreakable algorithm). For example: Mary, Smith nee Jones, born 10.11.1964 in Cardiff, mother’s maiden name Smith generates the code ('pseudonym'): 034-933-729. The purpose of collecting clinical data is two-fold: Firstly, it provides valuable information to help characterise the nature of the disease during all stages. Secondly, it can identify which patients with HD may be eligible for interventional trials. However, a patient will never be expected to take part in an interventional trial, this is entirely their choice. Study objectives To collect prospective data on the phenotypical characteristics of Huntington's disease (HD)mutation carriers regardless of whether they display clinical symptoms and signs of HD and of individuals who are part of an HD family (irrespective of their mutation carrier status), in order to obtain natural history data on a wide spectrum of HD patients, HD mutation carriers and individuals who are part of an HD family; expedite identification and recruitment of participants for clinical trials and plan future observational and interventional trials aimed at better symptom control or aimed at slowing or postponing the onset and progression of HD. To achieve these objectives, participants are asked to donate biosamples (blood and urine) for studies to identify genetic modifiers of HD and to establish and validate biological markers tracking the progressive course of HD; in this context a family history is requested as well in order to understand the relationships of clinical data sets and biosamples from related donors. In addition, non-mutation carrying family members of participants are asked to consider donating biosamples to serve as controls. Progress so far… There are currently over 100 study sites contributing data throughout Europe. Over the past 24 months the Euro-HD Network has made excellent progress. The website which forms the core infrastructure for the network can be viewed in multiple European languages. On the website a number of pages are visible to members of the public, for example information on the disease, contacting the Euro-HD Network, and finding out more information about the Network and the European study sites involved. Clinicians, scientists and HD-related professionals involved directly with the Euro-HD Network are provided with a username and password to login to the website. This permits entry to restricted pages, including access to pseudonymised data entered from their study site. However, members of one study site are unable to view data from any other site. The only people who have access to all UK data are Jenny and Olivia, and restricted members of the Central Coordination team (including Prof. Bernhard Landwehrmeyer). The first clinical trial involving the network started in 2006 and includes study sites in the UK, Germany, Italy and Spain. A total of 290 patients in the early-moderate stages of the disease are involved in the 6 month double-blind randomised placebo controlled study. This trial aims to assess the effects of Ethyl-EPA (a neuroprotective compound derived from fish oil) on the symptoms and course of the disease. This trial is now nearing completion and the Euro-HD Network will be coordinating an 18 month extension for those who are already enrolled. The network is also contributing to a US based observational study looking presymptomatic patients; PREDICT-HD. Euro-HD study sites are in Germany, the UK, and Spain. This study looks at markers of disease onset over a number of years. Next steps…. Over the past 12 months there has been rapid progress within the Euro-HD Network. To date there are over 1400 patients enrolled in Registry across Europe, with 400 patients are from UK sites. We hope to continue adding new study sites to the network, and this will also increase opportunities for patients to have access to disease management advice. The third AGM for the Euro-HD Network is arranged for 15th-16th September in Blankenberge, Belgium. The meeting will discuss the progress over the past year as well as updating members of the network with recent developments. Together with a number of keynote speakers, the meeting also provided an opportunity for all members to present and discuss their research into HD. One major step for the network is to consider the feasibility of future clinical trials based on the Registry cohort. The infrastructure is now in place for the Scientific Review board to consider other clinical trials. Public access to the website If you would like more information about the Euro-HD Network, please visit the website: http://www.euro-hd.net On the website, it is possible for you to make contact (anonymous if preferred) with the Network. This can be done by clicking on Network, and then under 'Project' you will see 'Contact', if you click on this a page will appear where you can enter your details if you would like to make contact with the Network. There is a list of the study sites involved around Europe and contact details are provided for Central Co-ordination and Language Co-ordinators. Also under Network, you will see Communication. By clicking on this you can gain access to a public chatroom and to (e)mail lists of people involved in co-ordinating Euro-HD (including contact details for Jenny and Olivia). Under Disease on the website there are interesting links and information about HD.
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