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Enroll-HD: An Integrated Clinical Research Platform and Worldwide Observational Study for Huntington's Disease
Established in July 2012, Enroll-HD is both an integrated clinical research platform and a worldwide observational study designed to meet the clinical research requirements necessary to develop therapeutics for Huntington's disease (HD). The platform offers participants a low-burden entry into...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8416308/ https://www.ncbi.nlm.nih.gov/pubmed/34484094 http://dx.doi.org/10.3389/fneur.2021.667420 |
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author | Sathe, Swati Ware, Jen Levey, Jamie Neacy, Eileen Blumenstein, Robi Noble, Simon Mühlbäck, Alzbeta Rosser, Anne Landwehrmeyer, G. Bernhard Sampaio, Cristina |
author_facet | Sathe, Swati Ware, Jen Levey, Jamie Neacy, Eileen Blumenstein, Robi Noble, Simon Mühlbäck, Alzbeta Rosser, Anne Landwehrmeyer, G. Bernhard Sampaio, Cristina |
author_sort | Sathe, Swati |
collection | PubMed |
description | Established in July 2012, Enroll-HD is both an integrated clinical research platform and a worldwide observational study designed to meet the clinical research requirements necessary to develop therapeutics for Huntington's disease (HD). The platform offers participants a low-burden entry into HD research, providing a large, well-characterized, research-engaged cohort with associated clinical data and biosamples that facilitates recruitment into interventional trials and other research studies. Additional studies that use Enroll-HD data and/or biosamples are built into the platform to further research on biomarkers and outcome measures. Enroll-HD is now operating worldwide in 21 countries at 159 clinical sites across four continents—Europe, North America, Latin America, and Australasia—and has recruited almost 25,000 participants, generating a large, rich clinical database with associated biosamples to expedite HD research; any researcher at a verifiable research organization can access the clinical datasets and biosamples from Enroll-HD and nested studies. Important operational features of Enroll-HD include a strong emphasis on standardization, data quality, and protecting participant identity, a single worldwide study protocol, a flexible EDC system capable of integrating multiple studies, a comprehensive monitoring infrastructure, an online portal to train and certify site personnel, and standardized study documents including informed consent forms and contractual agreements. |
format | Online Article Text |
id | pubmed-8416308 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-84163082021-09-04 Enroll-HD: An Integrated Clinical Research Platform and Worldwide Observational Study for Huntington's Disease Sathe, Swati Ware, Jen Levey, Jamie Neacy, Eileen Blumenstein, Robi Noble, Simon Mühlbäck, Alzbeta Rosser, Anne Landwehrmeyer, G. Bernhard Sampaio, Cristina Front Neurol Neurology Established in July 2012, Enroll-HD is both an integrated clinical research platform and a worldwide observational study designed to meet the clinical research requirements necessary to develop therapeutics for Huntington's disease (HD). The platform offers participants a low-burden entry into HD research, providing a large, well-characterized, research-engaged cohort with associated clinical data and biosamples that facilitates recruitment into interventional trials and other research studies. Additional studies that use Enroll-HD data and/or biosamples are built into the platform to further research on biomarkers and outcome measures. Enroll-HD is now operating worldwide in 21 countries at 159 clinical sites across four continents—Europe, North America, Latin America, and Australasia—and has recruited almost 25,000 participants, generating a large, rich clinical database with associated biosamples to expedite HD research; any researcher at a verifiable research organization can access the clinical datasets and biosamples from Enroll-HD and nested studies. Important operational features of Enroll-HD include a strong emphasis on standardization, data quality, and protecting participant identity, a single worldwide study protocol, a flexible EDC system capable of integrating multiple studies, a comprehensive monitoring infrastructure, an online portal to train and certify site personnel, and standardized study documents including informed consent forms and contractual agreements. Frontiers Media S.A. 2021-08-18 /pmc/articles/PMC8416308/ /pubmed/34484094 http://dx.doi.org/10.3389/fneur.2021.667420 Text en Copyright © 2021 Sathe, Ware, Levey, Neacy, Blumenstein, Noble, Mühlbäck, Rosser, Landwehrmeyer and Sampaio. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Neurology Sathe, Swati Ware, Jen Levey, Jamie Neacy, Eileen Blumenstein, Robi Noble, Simon Mühlbäck, Alzbeta Rosser, Anne Landwehrmeyer, G. Bernhard Sampaio, Cristina Enroll-HD: An Integrated Clinical Research Platform and Worldwide Observational Study for Huntington's Disease |
title | Enroll-HD: An Integrated Clinical Research Platform and Worldwide Observational Study for Huntington's Disease |
title_full | Enroll-HD: An Integrated Clinical Research Platform and Worldwide Observational Study for Huntington's Disease |
title_fullStr | Enroll-HD: An Integrated Clinical Research Platform and Worldwide Observational Study for Huntington's Disease |
title_full_unstemmed | Enroll-HD: An Integrated Clinical Research Platform and Worldwide Observational Study for Huntington's Disease |
title_short | Enroll-HD: An Integrated Clinical Research Platform and Worldwide Observational Study for Huntington's Disease |
title_sort | enroll-hd: an integrated clinical research platform and worldwide observational study for huntington's disease |
topic | Neurology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8416308/ https://www.ncbi.nlm.nih.gov/pubmed/34484094 http://dx.doi.org/10.3389/fneur.2021.667420 |
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