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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...

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Autores principales: Sathe, Swati, Ware, Jen, Levey, Jamie, Neacy, Eileen, Blumenstein, Robi, Noble, Simon, Mühlbäck, Alzbeta, Rosser, Anne, Landwehrmeyer, G. Bernhard, Sampaio, Cristina
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
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.
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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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