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Huntington Disease Clinical Trial Site Certification Scheme

The HD-CTTF holds details of certified clinical trial-ready sites. All sites meet a minimum standard of clinical trial capability and are confirmed as complying with a clearly defined set of clinical trial criteria focusing on quality, facilities, access to HD patients and site staff experience and training.

This provides a firm foundation for the selection of sites based on study-specific criteria and enables a more reliable and streamlined feasibility assessment resulting in the rapid selection of the most appropriate sites for each clinical trial.

 

The HD-CTTF works in collaboration with CHDI and EHDN, and has open access to the Registry and Enroll-HD platforms and participant databases. It is anticipated that most, if not all, Enroll-HD sites will apply for certification, in addition to sites not currently participating in Enroll-HD.

Certification of an HD clinical trial site involves assessment of a clearly visible set of industry-agreed, minimum generic clinical trial criteria and is open to all sites in the HD-CTTF’s regions of activity: Australia, Europe, Latin America, North America, New Zealand, Nordic regions and Russia.

The certification scheme reduces the administrative burden both for sites and sponsors during trial set-up by centrally storing information about site feasibility, training, and qualifications and utilizing this database to support the country and site selection process for approved sponsors.

With an increasing numbers of drugs coming through the development pipeline, there are expected to be multiple concurrent clinical trials in HD. Currently a relatively small pool of sites are regularly involved in HD trials, leaving little scope for expansion of recruitment capability.  The scheme will provide an opportunity to increase the visibility of high quality trial sites and provide guidance and support for less experienced sites to become trial-ready.

What is certification?

 Certification requires that a site meet a specific set of criteria designed to assess relevant HD clinical trial capability and performance, including general site background information, clinical trial infrastructure, HD patient cohort and staff training and education.

A pre-requisite for certification is the completion of the Global Site Investigator Database (GSID-HD). The GSID-HD captures extensive site information for feasibility assessment.

The below criteria must also be fulfilled:

  • At least 30 HD patients, or access to 30 HD patients, in Enroll-HD/Registry, or local patient database (for non Enroll-HD/Registry sites).
  • Good quality data (no significant audit or quality findings)
  • A medical doctor (MD) on the study team who can act as PrincipaI Investigator (PI) for trials
  • Staff trained in HD-specific assessments (PBA-s and UHDRS motor): at least one trained rater for each assessment.
  • A dedicated study coordinator (SC) for trials
  • GCP training within the last 3 years for clinical trial staff
  • Facilities: patient assessment, secure clinical data and IMP storage areas, space for monitoring, high speed internet access
  • SOPs: Informed Consent, IMP procedures, Handling Medical Emergencies
  • Clinical trial staff (minimum PI and SC) fluent in English language

 

How are eligibility criteria verified?

Applications are verified remotely using information provided via GSID-HD, CVs, Enroll-HD and EHDN training records and available quality metrics.  Following remote review, sites that meet all criteria will be awarded certification by the HD-CTTF (within 1 month of validated submission of a completed application). Certification will be annually renewable, via a re-application process involving review of any changes impacting site eligibility.

In addition, a complete on-site spot-check audit of the certification eligibility criteria will be undertaken for all sites during routine Enroll-HD monitoring visits (for non-Enroll-HD sites, alternative arrangements will be made).

Certification is not dependent on on-site review, however a failure to demonstrate the required criteria at the site visit would result in a review of eligibility, and suspension of certification if necessary.

The HD-CTTF maintains records and associated audits and manages renewal and any necessary suspensions of certification.

How is information about certified sites accessed?

 At a sponsor’s request, the HD-CTTF (cttf-hd@euro-hd.net) can access up-to-date details on certified sites, enabling a rapid and efficient feasibility process.

 

 

 

 

HD trials

HD trials