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A cross-cutting approach to enhancing clinical trial site success: The Department of Veterans Affairs' Network of Dedicated Enrollment Sites (NODES) model

BACKGROUND: Recruitment into clinical trials remains a key determinant to study completion and success. While various strategies have been proposed, it is unclear how they apply across different populations, diseases, and/or study goals. The ability to effectively overcome challenges may require dif...

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Autores principales: Condon, Debra L., Beck, Danielle, Kenworthy-Heinige, Tawni, Bratcher, Karen, O'Leary, Meghan, Asghar, Aliya, Willis, Cyenthia, Johnson, Marcus R., Huang, Grant D.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5936861/
https://www.ncbi.nlm.nih.gov/pubmed/29740639
http://dx.doi.org/10.1016/j.conctc.2017.03.006
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author Condon, Debra L.
Beck, Danielle
Kenworthy-Heinige, Tawni
Bratcher, Karen
O'Leary, Meghan
Asghar, Aliya
Willis, Cyenthia
Johnson, Marcus R.
Huang, Grant D.
author_facet Condon, Debra L.
Beck, Danielle
Kenworthy-Heinige, Tawni
Bratcher, Karen
O'Leary, Meghan
Asghar, Aliya
Willis, Cyenthia
Johnson, Marcus R.
Huang, Grant D.
author_sort Condon, Debra L.
collection PubMed
description BACKGROUND: Recruitment into clinical trials remains a key determinant to study completion and success. While various strategies have been proposed, it is unclear how they apply across different populations, diseases, and/or study goals. The ability to effectively overcome challenges may require different approaches that more broadly focus on addressing obstacles among sites that cannot be overcome by individual studies. METHODS: The Department of Veterans Affairs (VA) Cooperative Studies Program (CSP) established the Network of Dedicated Enrollment Sites (NODES) as a consortium of sites to generate systematic site-level solutions to more efficiently recruit in CSP studies. Initial activities identified priorities and developed approaches through team-based efforts. Metrics were also developed to assess overall network performance. RESULTS: Network efforts produced several new strategies and best practices for common problems in CSP research. Recruitment strategies included bringing studies to patients and developing data programs using algorithms for finding eligible patients. Efficiency efforts focused on cross-training and standardizing performance reports. CONCLUSION: NODES addressed site challenges in clinical trial recruitment and management by taking an overall approach that looked at the system rather than individual studies. Practices and operational changes were implemented for CSP research related to recruitment, staff training and research methodology. The network activities suggest that team-based development of tools and insights may help better identify targets and increase efficiencies for clinical trials recruitment.
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spelling pubmed-59368612018-05-08 A cross-cutting approach to enhancing clinical trial site success: The Department of Veterans Affairs' Network of Dedicated Enrollment Sites (NODES) model Condon, Debra L. Beck, Danielle Kenworthy-Heinige, Tawni Bratcher, Karen O'Leary, Meghan Asghar, Aliya Willis, Cyenthia Johnson, Marcus R. Huang, Grant D. Contemp Clin Trials Commun Article BACKGROUND: Recruitment into clinical trials remains a key determinant to study completion and success. While various strategies have been proposed, it is unclear how they apply across different populations, diseases, and/or study goals. The ability to effectively overcome challenges may require different approaches that more broadly focus on addressing obstacles among sites that cannot be overcome by individual studies. METHODS: The Department of Veterans Affairs (VA) Cooperative Studies Program (CSP) established the Network of Dedicated Enrollment Sites (NODES) as a consortium of sites to generate systematic site-level solutions to more efficiently recruit in CSP studies. Initial activities identified priorities and developed approaches through team-based efforts. Metrics were also developed to assess overall network performance. RESULTS: Network efforts produced several new strategies and best practices for common problems in CSP research. Recruitment strategies included bringing studies to patients and developing data programs using algorithms for finding eligible patients. Efficiency efforts focused on cross-training and standardizing performance reports. CONCLUSION: NODES addressed site challenges in clinical trial recruitment and management by taking an overall approach that looked at the system rather than individual studies. Practices and operational changes were implemented for CSP research related to recruitment, staff training and research methodology. The network activities suggest that team-based development of tools and insights may help better identify targets and increase efficiencies for clinical trials recruitment. Elsevier 2017-03-29 /pmc/articles/PMC5936861/ /pubmed/29740639 http://dx.doi.org/10.1016/j.conctc.2017.03.006 Text en http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Article
Condon, Debra L.
Beck, Danielle
Kenworthy-Heinige, Tawni
Bratcher, Karen
O'Leary, Meghan
Asghar, Aliya
Willis, Cyenthia
Johnson, Marcus R.
Huang, Grant D.
A cross-cutting approach to enhancing clinical trial site success: The Department of Veterans Affairs' Network of Dedicated Enrollment Sites (NODES) model
title A cross-cutting approach to enhancing clinical trial site success: The Department of Veterans Affairs' Network of Dedicated Enrollment Sites (NODES) model
title_full A cross-cutting approach to enhancing clinical trial site success: The Department of Veterans Affairs' Network of Dedicated Enrollment Sites (NODES) model
title_fullStr A cross-cutting approach to enhancing clinical trial site success: The Department of Veterans Affairs' Network of Dedicated Enrollment Sites (NODES) model
title_full_unstemmed A cross-cutting approach to enhancing clinical trial site success: The Department of Veterans Affairs' Network of Dedicated Enrollment Sites (NODES) model
title_short A cross-cutting approach to enhancing clinical trial site success: The Department of Veterans Affairs' Network of Dedicated Enrollment Sites (NODES) model
title_sort cross-cutting approach to enhancing clinical trial site success: the department of veterans affairs' network of dedicated enrollment sites (nodes) model
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5936861/
https://www.ncbi.nlm.nih.gov/pubmed/29740639
http://dx.doi.org/10.1016/j.conctc.2017.03.006
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