Become a Study Site

How to Become a Study Site

On July 23, 2012 the first patient entered the Enroll-HD study.  Since then the study has experienced unprecedented recruitment. The incredible success of participant recruitment is largely due to the dedication of the many HD clinicians and study coordinators worldwide and the ability of Enroll-HD to build on the many previous foundational observational studies.

The focus of clinical trials in neurodegenerative diseases over the last decade has moved to exploring interventions earlier in the disease process.  To facilitate these studies it is critical to have a large, well-characterized cohort of participants ready that can be quickly recruited.  We are seeking Enroll-HD sites that focus their recruitment on premanifest and early manifest HD gene carriers to help us achieve this goal.

Requirements

Patients

  • Identify participants within a reasonable geographical area, who are prepared to participate in a non-treatment observational study and complete all core components of the study.
  • Recruit and retain of a minimum of 50 participants, including at least 20 premanifest/at risk.
  • Follow up each participant at annual visits. Long term retention is a key component for the study.

Facilities

  • Designate clinic space for interview and assessment of participants and their families/carers during core assessments of up to 45 minutes of duration.
  • Draw, process and dispatch blood samples to a central laboratory
  • Access the Enroll-HD web portal and transfer data onto EDC allowing direct data entry during, or at least within 2 week after, conduct of the study visit.

Staff

  • A site team including an MD, preferably the PI has an MD and expertise in HD. In certain regions, there may be equally qualified and appropriately trained PhDs who can serve as Enroll-HD PIs. In such cases an MD is required to be part of the team as sub investigator.
  • Site staff with a working knowledge of English.
  • Trained Enroll-HD study staff with experience and a willingness to complete training in ENROLL-HD specific assessments and relevant annual motor UHDRS certification.
  • A recognised referral path or Standard Operating Procedure (SOP) for mental health issues to a Psychiatrist or other mental health care provider, preferably with HD experience.
  • A referral path for participants who wish to undergo genetic testing.

Institutional structure

  • Access to a GCP-compliant local or regional Ethics Committee, Institutional Review Board (IRB) or equivalent
  • Access to and awareness of any other local or regional agency approvals
  • Ability to contract via local institutional (public or private) finance/legal department
  • Willingness to accept CHDI Site Agreement template.

If you’d like to participate and your clinic is suited to join the study, please contact info@enroll-hd.org, and fill out the Global Site & Investigator Feasibility Questionnaire.

Other ways to be involved

If joining Enroll-HD is not feasible for your clinic right now, other ways to support HD research include:

GSID

To add information about your study site to the Global Site & Investigator Feasibility Questionnaire on Huntington’s disease please visit the GSID website