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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...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2023
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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. |
format | Online Article Text |
id | pubmed-10631637 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
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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