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F02 Enroll-HD study status
  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. Its objectives are: 1) expedite the conduct of clinical trials; 2) improve understanding of HD; 3) foster good clinical care. July 25, 2022 marks the 10 year anniversary since the first Enroll-HD participant. As of June 1, 2022, 27,725 participants have been recruited from 183 sites (154 are active) in 22 countries. 20,975 of those are still current (i.e. no mortality/end form) and 14,706 are active (i.e. have not missed two or more visits). Two sites have reached 1,000 participants enrolled. Since the start of the pandemic until March 2022 the number of active study participants steadily declined. However, since March 2022 this number has remained stable. Study data is monitored using a risk-based approach. Recoded data and biosamples are made available to researchers. There have been approximately 350 projects and 100 publications using Enroll-HD data and samples. An increasing number of studies (platform studies, e.g. HDClarity) are utilizing at least one area of Enroll-HD platform support, such as site feasibility, guidance on study design, potentially eligible participant listings, study set-up support, monitoring and data management. The Enroll-HD Clinical Training Portal offers online training for the UHDRS Motor Certification, GCP (all users), and Enroll-HD Plasma Collection (Enroll-HD users). Training modules have recently expanded to support other studies hosted by the platform. The portal successfully enables faster, cost-effective start-up and standardization of training.

  • Enroll-HD
  • observational
  • platform
  • dataset
  • global registry

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