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The Joint Mobile Emerging Disease Clinical Capability (JMEDICC) laboratory approach: Capabilities for high-consequence pathogen clinical research

Following the 2013–2016 Ebola virus outbreak in West Africa, numerous groups advocated for the importance of executing clinical trials in outbreak settings. The difficulties associated with obtaining reliable data to support regulatory approval of investigational vaccines and therapeutics during tha...

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Autores principales: Naluyima, Prossy, Kayondo, Willy, Ritchie, Chi, Wandege, Joseph, Kagabane, Sharon, Tumubeere, Lydia, Kusiima, Brenda, Kibombo, Daniel, Atukunda, Sharon, Nanteza, Christine, Nabirye, Harriet, Mugabi, Francis Bunjo, Namuyanja, Sarah, Hatcher, Christopher, Rauch, Hypaitia, Mukembo, Moses, Musinguzi, Patrick, Sanders, Nathan, Turesson, Elizabeth, Cando, Christian, Walwema, Richard, Mimbe, Derrick, Hepburn, Janice, Clark, Danielle, Lamorde, Mohammed, Kibuuka, Hannah, Zaman, Saima, Cardile, Anthony P., Martins, Karen A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6922336/
https://www.ncbi.nlm.nih.gov/pubmed/31856153
http://dx.doi.org/10.1371/journal.pntd.0007787
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author Naluyima, Prossy
Kayondo, Willy
Ritchie, Chi
Wandege, Joseph
Kagabane, Sharon
Tumubeere, Lydia
Kusiima, Brenda
Kibombo, Daniel
Atukunda, Sharon
Nanteza, Christine
Nabirye, Harriet
Mugabi, Francis Bunjo
Namuyanja, Sarah
Hatcher, Christopher
Rauch, Hypaitia
Mukembo, Moses
Musinguzi, Patrick
Sanders, Nathan
Turesson, Elizabeth
Cando, Christian
Walwema, Richard
Mimbe, Derrick
Hepburn, Janice
Clark, Danielle
Lamorde, Mohammed
Kibuuka, Hannah
Zaman, Saima
Cardile, Anthony P.
Martins, Karen A.
author_facet Naluyima, Prossy
Kayondo, Willy
Ritchie, Chi
Wandege, Joseph
Kagabane, Sharon
Tumubeere, Lydia
Kusiima, Brenda
Kibombo, Daniel
Atukunda, Sharon
Nanteza, Christine
Nabirye, Harriet
Mugabi, Francis Bunjo
Namuyanja, Sarah
Hatcher, Christopher
Rauch, Hypaitia
Mukembo, Moses
Musinguzi, Patrick
Sanders, Nathan
Turesson, Elizabeth
Cando, Christian
Walwema, Richard
Mimbe, Derrick
Hepburn, Janice
Clark, Danielle
Lamorde, Mohammed
Kibuuka, Hannah
Zaman, Saima
Cardile, Anthony P.
Martins, Karen A.
author_sort Naluyima, Prossy
collection PubMed
description Following the 2013–2016 Ebola virus outbreak in West Africa, numerous groups advocated for the importance of executing clinical trials in outbreak settings. The difficulties associated with obtaining reliable data to support regulatory approval of investigational vaccines and therapeutics during that outbreak were a disappointment on a research and product development level, as well as on a humanitarian level. In response to lessons learned from the outbreak, the United States Department of Defense established a multi-institute project called the Joint Mobile Emerging Disease Intervention Clinical Capability (JMEDICC). JMEDICC’s primary objective is to establish the technical capability in western Uganda to execute clinical trials during outbreaks of high-consequence pathogens such as the Ebola virus. A critical component of clinical trial execution is the establishment of laboratory operations. Technical, logistical, and political challenges complicate laboratory operations, and these challenges have been mitigated by JMEDICC to enable readiness for laboratory outbreak response operations.
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spelling pubmed-69223362020-01-07 The Joint Mobile Emerging Disease Clinical Capability (JMEDICC) laboratory approach: Capabilities for high-consequence pathogen clinical research Naluyima, Prossy Kayondo, Willy Ritchie, Chi Wandege, Joseph Kagabane, Sharon Tumubeere, Lydia Kusiima, Brenda Kibombo, Daniel Atukunda, Sharon Nanteza, Christine Nabirye, Harriet Mugabi, Francis Bunjo Namuyanja, Sarah Hatcher, Christopher Rauch, Hypaitia Mukembo, Moses Musinguzi, Patrick Sanders, Nathan Turesson, Elizabeth Cando, Christian Walwema, Richard Mimbe, Derrick Hepburn, Janice Clark, Danielle Lamorde, Mohammed Kibuuka, Hannah Zaman, Saima Cardile, Anthony P. Martins, Karen A. PLoS Negl Trop Dis Viewpoints Following the 2013–2016 Ebola virus outbreak in West Africa, numerous groups advocated for the importance of executing clinical trials in outbreak settings. The difficulties associated with obtaining reliable data to support regulatory approval of investigational vaccines and therapeutics during that outbreak were a disappointment on a research and product development level, as well as on a humanitarian level. In response to lessons learned from the outbreak, the United States Department of Defense established a multi-institute project called the Joint Mobile Emerging Disease Intervention Clinical Capability (JMEDICC). JMEDICC’s primary objective is to establish the technical capability in western Uganda to execute clinical trials during outbreaks of high-consequence pathogens such as the Ebola virus. A critical component of clinical trial execution is the establishment of laboratory operations. Technical, logistical, and political challenges complicate laboratory operations, and these challenges have been mitigated by JMEDICC to enable readiness for laboratory outbreak response operations. Public Library of Science 2019-12-19 /pmc/articles/PMC6922336/ /pubmed/31856153 http://dx.doi.org/10.1371/journal.pntd.0007787 Text en https://creativecommons.org/publicdomain/zero/1.0/ This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 (https://creativecommons.org/publicdomain/zero/1.0/) public domain dedication.
spellingShingle Viewpoints
Naluyima, Prossy
Kayondo, Willy
Ritchie, Chi
Wandege, Joseph
Kagabane, Sharon
Tumubeere, Lydia
Kusiima, Brenda
Kibombo, Daniel
Atukunda, Sharon
Nanteza, Christine
Nabirye, Harriet
Mugabi, Francis Bunjo
Namuyanja, Sarah
Hatcher, Christopher
Rauch, Hypaitia
Mukembo, Moses
Musinguzi, Patrick
Sanders, Nathan
Turesson, Elizabeth
Cando, Christian
Walwema, Richard
Mimbe, Derrick
Hepburn, Janice
Clark, Danielle
Lamorde, Mohammed
Kibuuka, Hannah
Zaman, Saima
Cardile, Anthony P.
Martins, Karen A.
The Joint Mobile Emerging Disease Clinical Capability (JMEDICC) laboratory approach: Capabilities for high-consequence pathogen clinical research
title The Joint Mobile Emerging Disease Clinical Capability (JMEDICC) laboratory approach: Capabilities for high-consequence pathogen clinical research
title_full The Joint Mobile Emerging Disease Clinical Capability (JMEDICC) laboratory approach: Capabilities for high-consequence pathogen clinical research
title_fullStr The Joint Mobile Emerging Disease Clinical Capability (JMEDICC) laboratory approach: Capabilities for high-consequence pathogen clinical research
title_full_unstemmed The Joint Mobile Emerging Disease Clinical Capability (JMEDICC) laboratory approach: Capabilities for high-consequence pathogen clinical research
title_short The Joint Mobile Emerging Disease Clinical Capability (JMEDICC) laboratory approach: Capabilities for high-consequence pathogen clinical research
title_sort joint mobile emerging disease clinical capability (jmedicc) laboratory approach: capabilities for high-consequence pathogen clinical research
topic Viewpoints
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6922336/
https://www.ncbi.nlm.nih.gov/pubmed/31856153
http://dx.doi.org/10.1371/journal.pntd.0007787
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