Article Text
Abstract
Enroll-HD is a global research platform with the infrastructure to support clinical trials and studies in Huntington’s disease (HD). The prospective, observational, longitudinal Enroll-HD study at the core of the platform is active in 21 countries and has recruited 25,752 participants (19,846 currently active), who have completed standardised clinical assessments and biosample collections at annual visits at 178 study sites (157 currently active) (as at 1-Jun-21).
The Enroll-HD platform makes resources and support available to the HD research community, including periodic clinical datasets and biosamples; advice on protocol development; protocol review; assistance with study feasibility, site identification and feasibility; participant recruitment; and site staff training and certification through the Enroll-HD clinical training portal.
Long-standing working relationships with the clinical sites have been built over time through the operational management of Enroll-HD, which enables well-informed site identification and feasibility based on extensive knowledge of sites’ capabilities, historic performance, and information about sites’ access to potential participants. This site intelligence is supported by both the Enroll-HD HD Clinical Trial Site Certification scheme that assesses potential trial sites (within and outside Enroll-HD) against a set of standard minimum criteria for clinical trial participation, and the Enroll-HD participant database that enables powerful in-silico screening using study-specific inclusion and exclusion criteria to identify potentially eligible participants who can be invited into interventional trials. In addition, the platform can provide support for participant referrals from neighbouring Enroll-HD sites into the selected study sites.