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F48 Enroll-HD study status
  1. The Enroll-HD Platform Team
  1. The Enroll-HD Platform Team

Abstract

Background Enroll-HD is a clinical research platform that includes at its core an observational, prospective study of HD. The objectives of Enroll-HD are: 1) enhance the design and expedite the conduct of clinical trials; 2) improve the understanding of the phenotypic spectrum and disease mechanisms; 3) foster good clinical care.

25,752 participants (19, 846 currently active) have been recruited from 178 study sites (157 currently active) in 21 countries (as of June 1, 2021). The data collected from these participants is monitored using a rigorous risk-based process. Recoded data and biosamples are made available to researchers. As of June 1, 2021, more than 350 projects were conducted, and more than 70 publications have been published using the Enroll-HD data.

Enroll-HD also serves as a registry that can be used to facilitate recruitment by identifying potentially eligible participants who can be invited by investigators to participate in clinical trials. To improve support for future clinical trials and observational studies, the study has successfully refocused its recruitment strategy to increase participants in the at risk, premanifest and early-stage HD participant subgroups.

Throughout the Covid-19 pandemic, the study team encouraged the sites to keep the participants engaged in the study and collect some data through phone contacts. Since the end of Q2 2020, a gradual reopening of the sites has been observed (as of June 1, 2021, 144 sites out of 157 have resumed study activities).

Platform studies are clinical studies that utilize at least one or more types of Enroll-HD platform support. These include site feasibility, study guidance documents and templates, potentially eligible participant listings, study set-up support, monitoring and data management.

The Enroll-HD Clinical Training Portal is an online resource launched in January 2017 where HD research personnel can complete and maintain study-relevant training, presently UHDRS Motor Certification, GCP (all users), and Enroll-HD Plasma Collection (Enroll-HD study users only). With more than 1,850 active users, the portal aims to enable faster, more cost-effective start-up of clinical trials and studies, standardizes the quality of training, and reduces workload at sites.

  • enroll-HD
  • observational studies

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