Study feasibility analyses are performed in silico using the Enroll-HD platform participant database. Study/trial specific parameters are applied as filters to the database to estimate approximate available sample size. These filters typically include participant eligibility criteria and geographic region(s) of interest.

The Enroll-HD platform has an extensive and well-established international site and investigator network, fostered through conduct of the Enroll-HD study.

Many sites in this network are also certified under the HD Clinical Trial Site Certification scheme – open to both Enroll-HD and non-Enroll-HD study sites – which involves a more detailed assessment of sites’ interest, capability and experience, informing suitability for participation in interventional clinical trials.

In addition to in-house knowledge of individual site operations, capabilities, and performance, the platform also maintains a Global Site Investigator Database (GSID-HD) to support identification of suitable sites for trials; GSID-HD is a regularly updated central feasibility database containing comprehensive information about site capabilities and facilities.

Adopting the same approach utilized for feasibility analyses, trial/study recruitment is facilitated through interrogation of the Enroll-HD study database to identify potentially eligible participants at each study site identified. Participating sites receive a list of their potential participants to support study screening activities.

Local referral networks can also be used to support and bolster recruitment, for example, leveraging participant populations at Enroll-HD sites that are not participating in the trial/study.

The platform has established links with local patient organizations and regional advocacy groups and can facilitate introductions to explore potential support with recruitment where needed.

Upon request from a clinical study sponsor, resolution of site-level issues can be facilitated via the Enroll-HD platform’s dedicated network of centrally managed regional staff who have close working relationships with site staff. Communications are closely coordinated between the sponsor and the central point of contact in the platform team.

Enroll-HD study data may be linked to external study data. Sponsors may leverage existing/historic Enroll-HD data to provide ‘run in’ data for participants in a study or trial (e.g., disease trajectory analysis). Sponsors may also choose to ‘nest’ their study in Enroll-HD, leveraging collection of prospective data elements common to both their own study and that of Enroll-HD, in addition to collecting unique data elements, thus minimizing participant burden and cost.

The Enroll-HD training platform enables virtual training and certification for a number of HD-specific assessments/rating scales. Access to these materials is provided via the Training Portal.

For general enquiries, including PBA-s training, please contact us.

Data monitoring support may be available to non-therapeutic studies on request.

Data monitoring services are not available for therapeutic trials.