K012 Enroll-HD platform support for clinical trials and studies in Huntington’s disease

<h3></h3> Enroll-HD is a global research platform with 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 recruiting at more than 150 clinical sites in 23 countries. Enroll-HD makes multiple resources available to the HD research community. These include clinical datasets and biosamples, scientific and clinical advice on protocol design, study feasibility, site identification, support with participant recruitment, and site staff training and certification via a clinical training portal. Several CHDI clinical studies have utilised a nested study design, such that Enroll-HD participant data are part of the nested study’s schedule of assessments. These nested studies, which include HDClarity, imageClarity, and Later Stage Assessments for HD, use the platform infrastructure for study execution (e.g. EDC, monitoring resources). Enroll-HD study data can also be used as run-in data to supplement trial analyses or as a natural history comparator. Long-standing relationships with clinical sites have been established through operational management and monitoring of Enroll-HD and platform studies; this enables well-informed site identification and feasibility assessment. Site intelligence is further supported in-silico screening of the Enroll-HD study database using study-specific inclusion criteria to identify potentially eligible participants, the Enroll-HD HD Clinical Trial Site Certification scheme which evaluates capability for HD clinical trial participation, and the HD Global Site Investigator (GSID-HD) feasibility database.