Research
An Update from the Enroll-HD Communications Group
Dear HD Community Member
You have probably heard about a new study, Enroll-HD. This email will provide you with a brief overview, some details, a brief overview and the schedule for its launch.
Enroll-HD is a very exciting global initiative that will include families in Europe, North America, Latin America, Australasia and parts of Asia. It is a potentially groundbreaking initiative project that builds upon the knowledge gained from the COHORT study in the U.S., Canada and Australia, and the similar REGISTRY study in Europe and Asia. Enroll-HD is an example of the unique international collaborative nature on of HD scientists and clinicians around the world and may could become the most comprehensive international medical study to date.
The information gathered through Enroll-HD will help accelerate the development of treatments for Huntington’s disease;, as it will create a data base of information about people affected by HD (although individuals will not be identifiable for any individual) and a repository of biological samples that will allow researchers and clinicians to better understand the progression of the disease. This information will be available to any HD investigator worldwide, and will contribute to the development of better tools and methods to measure HD the progression of HD, provide better clinical care for people with HD, and shorten the time it takes to do clinical trials of potential therapeutic treatments.
Transition from COHORT AND and REGISTRY to Enroll-HD: Progress to date
The COHORT and REGISTRY studies will now combine into the single, unified, global study, Enroll-HD, and the large majority of clinical sites involved in the COHORT and REGISTRY studies will become Enroll-HD clinical sites. Added to that there will be new clinical sites in Latin America and other regions of the world.
Many, if not all, clinical sites participating in COHORT will simply transition over to the new Enroll-HD study, and clinical visits for participants will be very similar to the COHORT ones. However, the transition from COHORT over to Enroll-HD will not be as smooth as first hoped, and there will now be a short interruption in the study visit schedule; this is so that the clinical sites can have the new Enroll-HD protocol (the guidelines that govern the new Enroll-HD study) approved by their local IRB (institutional review board) before they resume clinical visits.
Details are The Enroll-HD protocol is now being finalized and Enroll-HD sites are preparing for the transition to the new study., If you are currently a participant in either studyCOHORT, you will be receiving specific information about the changeover to Enroll-HD directly from your clinical site. If you are not currently participating in COHORT or REGISTRY you will have the opportunity to join Enroll-HD as soon as the current sites, as well as and the many new clinical sites, announce the start of Enroll-HD in the months ahead. Please visit www.Enroll-HD.org for updates and announcements of Enroll-HD sites as they come onlinebecome active and start to see patients.
Enroll-HD – General progress
The start up and management of Enroll-HD will be in two key stages: The Enroll-HD Executive Oversight Committee (EOC) and a series of nine Working Groups (WGs) have been working on study specifics since the start of the yearfor several months now. All The study protocols areis nearing completion and itand other details will be made available as theyonce are finalized. The drafting of the Enroll-HD study protocol and the development of trial procedures are being designed to ensure best data-sharing practices , with an emphasis on data protection, ensuring anonymity for participants, and the storage and safeguarding of biological samples, all in accordance with respective local laws, are the primary focus at this time.
An important element of the design and administration of Enroll-HD will be representation on the many working groups of individuals from all constituencies of the HD community (clinicians, patients, families, researchers, advocates) and representation by people from all parts of the global HD community. The WGs are now established and beginning their work but anyone still wishing to participate should contact Joe Giuliano (joseph.giuliano@chdifoundation.org).
The official launch date of Enroll-HD was originally scheduled to be July 1, 2011 but, given the complexities of developing a study protocol that will respect the privacy of its participants and will be legally and scientifically acceptable in such a large number of countries, that date is now looking ratheroverly optimistic. The goal now is to have at leastas many sites as possible some sites transition from COHORT and REGISTRY to Enroll-HD by the end of 2011, with a further widespread launch in the first quarter of 2012. Sites will continue to be added as the administrators of Enroll-HD work through the different approval procedures on a country-by-country basis.
To facilitate assist with the standardization of data collection and management across the global study and provide support to sites and networks like the EHDN, the Enroll-HD EOC and CHDI Foundation selected a contract research organization (CRO), Outcome Sciences, an established and experienced multinational organization that has particular expertise in patient registry studies. Outcome Sciences led the development of the US government handbook "Registries for Evaluating Patient Outcomes: A User's Guide" (http://www.outcome.com/ahrq-registries-evaluating-patient-outcome.htm). They will also play an important supportive role throughout the consultation and implementation phases.
The Communications WG will now begin to issue periodic updates for investigators and the wider HD community outlining the progress of the various WGs; a devoted Enroll-HD website for patients, families, and investigators is planned but, however you can already visit www.Enroll-HD.org to follow the progress and development of this international initiative. You can also join the Enroll-HD mailing list at Info@Enroll-HD.org.
Please join the international HD community in making Enroll-HD a success. In addition to the countries participating in COHORT and REGISTRY, the new Red Latinoamericana de Huntington (RLAH) in Latin America, will also join Enroll-HD. The REGISTRY, COHORT, and RLAH countries that will join Enroll-HD include:
Argentina
Australia
Austria
Belgium
Brazil
Canada
Chile
Czech Republic
Denmark
Ecuador
Finland
France
Germany
Italy
Netherlands
Norway
Peru
Poland
Portugal
Russia
Singapore
South Korea
Spain
Sweden
Switzerland
United Kingdom
USA
Venezuela
The COHORT, REGISTRY, and Enroll-HD studies are supported by CHDI Foundation.