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F01 Enroll-HD platform support for clinical trial and study sponsors
  1. The Enroll-HD Platform Team

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 22 countries and has recruited 27,725 participants (20,975 of are current (i.e. no mortality/end form) and 14,706 are active (i.e. have not missed >=2 visits) who have completed standardised clinical assessments and biosample collections at annual visits at 183 study sites (154 active) (as at 1-Jun-22). This year marks the 10th anniversary since the first participant was enrolled into the study. The Enroll-HD platform makes resources available to the HD research community, including multiple clinical datasets and biosamples; advice on protocol design, including linking to the Enroll-HD study (i.e. nested study design); assistance with study feasibility, site identification and feasibility; participant recruitment; and site staff training and certification via the Enroll-HD clinical training portal. Long-standing working relationships with the clinical sites have been built through the operational management of Enroll-HD and platform studies, which enables well-informed site identification and feasibility assessment based on extensive knowledge of sites’ capabilities, historic performance, and information about access to potential participants. This site intelligence is supported by both the Enroll-HD HD Clinical Trial Site Certification scheme that assesses sites (within and outside Enroll-HD) against a set of standard minimum criteria for clinical trial participation, and the Enroll-HD study database that enables powerful in-silico screening using study-specific inclusion and exclusion criteria to identify potentially eligible participants who can be considered for interventional trials. The platform can also facilitate participant referrals from neighbouring Enroll-HD sites into the selected trial site.

  • Enroll-HD
  • platform
  • clinical trial
  • certification
  • feasibility
  • recruitment

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