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Data-driven epidemiologic approach to conducting site feasibility for a global phase III tuberculosis vaccine clinical trial

An efficacious tuberculosis (TB) vaccine is critical to reducing the global burden of TB. TB vaccine trials require the identification of multiple sites globally that have both a high incidence of TB and the capacity to conduct a clinical trial. To expand the diversity of potential phase III TB vacc...

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Autores principales: Mui, Wai-Ling, Parekh, Falgunee K., Tseng, Ashley S., Toro, Joy, Craig, Taylor, Ndugga, Maggwa, Schmidt, Alexander C., Dagnew, Alemnew F., Penz, Craig, Belai, Ghiorghis
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10631637/
https://www.ncbi.nlm.nih.gov/pubmed/37939024
http://dx.doi.org/10.1371/journal.pgph.0002544
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author Mui, Wai-Ling
Parekh, Falgunee K.
Tseng, Ashley S.
Toro, Joy
Craig, Taylor
Ndugga, Maggwa
Schmidt, Alexander C.
Dagnew, Alemnew F.
Penz, Craig
Belai, Ghiorghis
author_facet Mui, Wai-Ling
Parekh, Falgunee K.
Tseng, Ashley S.
Toro, Joy
Craig, Taylor
Ndugga, Maggwa
Schmidt, Alexander C.
Dagnew, Alemnew F.
Penz, Craig
Belai, Ghiorghis
author_sort Mui, Wai-Ling
collection PubMed
description An efficacious tuberculosis (TB) vaccine is critical to reducing the global burden of TB. TB vaccine trials require the identification of multiple sites globally that have both a high incidence of TB and the capacity to conduct a clinical trial. To expand the diversity of potential phase III TB vaccine trial sites to be considered for inclusion, we describe a novel epidemiologic method that incorporates approaches from a variety of public health practices. Our approach incorporates analytic methodology to enable quantification and validation of qualitative information from disparate data sources, and epidemiologic analysis to systematically assess site-specific TB epidemiology. The integration of robust data-driven practices, and more quantitatively focused analysis, allowed for the objective evaluation of sites, which resulted in the identification of sites and catchment areas with high TB burden that may not have been previously considered. This suggests that an integrated epidemiologic methodology, not traditionally utilized for clinical trial site evaluations, could be integrated into site feasibility assessments as it results in more rapid site identification and reduces unintended bias.
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spelling pubmed-106316372023-11-08 Data-driven epidemiologic approach to conducting site feasibility for a global phase III tuberculosis vaccine clinical trial Mui, Wai-Ling Parekh, Falgunee K. Tseng, Ashley S. Toro, Joy Craig, Taylor Ndugga, Maggwa Schmidt, Alexander C. Dagnew, Alemnew F. Penz, Craig Belai, Ghiorghis PLOS Glob Public Health Research Article An efficacious tuberculosis (TB) vaccine is critical to reducing the global burden of TB. TB vaccine trials require the identification of multiple sites globally that have both a high incidence of TB and the capacity to conduct a clinical trial. To expand the diversity of potential phase III TB vaccine trial sites to be considered for inclusion, we describe a novel epidemiologic method that incorporates approaches from a variety of public health practices. Our approach incorporates analytic methodology to enable quantification and validation of qualitative information from disparate data sources, and epidemiologic analysis to systematically assess site-specific TB epidemiology. The integration of robust data-driven practices, and more quantitatively focused analysis, allowed for the objective evaluation of sites, which resulted in the identification of sites and catchment areas with high TB burden that may not have been previously considered. This suggests that an integrated epidemiologic methodology, not traditionally utilized for clinical trial site evaluations, could be integrated into site feasibility assessments as it results in more rapid site identification and reduces unintended bias. Public Library of Science 2023-11-08 /pmc/articles/PMC10631637/ /pubmed/37939024 http://dx.doi.org/10.1371/journal.pgph.0002544 Text en © 2023 Mui et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Mui, Wai-Ling
Parekh, Falgunee K.
Tseng, Ashley S.
Toro, Joy
Craig, Taylor
Ndugga, Maggwa
Schmidt, Alexander C.
Dagnew, Alemnew F.
Penz, Craig
Belai, Ghiorghis
Data-driven epidemiologic approach to conducting site feasibility for a global phase III tuberculosis vaccine clinical trial
title Data-driven epidemiologic approach to conducting site feasibility for a global phase III tuberculosis vaccine clinical trial
title_full Data-driven epidemiologic approach to conducting site feasibility for a global phase III tuberculosis vaccine clinical trial
title_fullStr Data-driven epidemiologic approach to conducting site feasibility for a global phase III tuberculosis vaccine clinical trial
title_full_unstemmed Data-driven epidemiologic approach to conducting site feasibility for a global phase III tuberculosis vaccine clinical trial
title_short Data-driven epidemiologic approach to conducting site feasibility for a global phase III tuberculosis vaccine clinical trial
title_sort data-driven epidemiologic approach to conducting site feasibility for a global phase iii tuberculosis vaccine clinical trial
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10631637/
https://www.ncbi.nlm.nih.gov/pubmed/37939024
http://dx.doi.org/10.1371/journal.pgph.0002544
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