Cargando…
Conventional Wisdom versus Actual Outcomes: Challenges in the Conduct of an Ebola Vaccine Trial in Liberia during the International Public Health Emergency
Clinical trials are challenging endeavors. Planning and implementing an investigational vaccine trial in Liberia, in the midst of an Ebola virus disease (EVD) epidemic that World Health Organization classified a public health emergency of international concern, presented extraordinary challenges. No...
Autores principales: | , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
The American Society of Tropical Medicine and Hygiene
2017
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5508914/ https://www.ncbi.nlm.nih.gov/pubmed/28719299 http://dx.doi.org/10.4269/ajtmh.16-1015 |
_version_ | 1783249946833584128 |
---|---|
author | Larson, Gregg S. Baseler, Beth R. Hoover, Marie L. Pierson, Jerome F. Tegli, Jemee K. Johnson, Melvin P. Kieh, Mark W. S. McNay, Laura A. Njoh, Wissedi Sio |
author_facet | Larson, Gregg S. Baseler, Beth R. Hoover, Marie L. Pierson, Jerome F. Tegli, Jemee K. Johnson, Melvin P. Kieh, Mark W. S. McNay, Laura A. Njoh, Wissedi Sio |
author_sort | Larson, Gregg S. |
collection | PubMed |
description | Clinical trials are challenging endeavors. Planning and implementing an investigational vaccine trial in Liberia, in the midst of an Ebola virus disease (EVD) epidemic that World Health Organization classified a public health emergency of international concern, presented extraordinary challenges. Normally, years of preparation and a litany of tasks lay the groundwork for a successful, randomized, blinded, placebo-controlled trial focused on safety and efficacy. Difficult research settings, unpredictable events, and other unique circumstances can add complexity. The setting in Liberia was especially problematic due to an infrastructure still badly damaged following a lengthy civil war and a very fragile health-care system that was further devastated by the EVD outbreak. The Partnership for Research on Vaccines in Liberia I EVD vaccine trial was planned and implemented in less than 3 months by a Liberian and U.S. research partnership, and its Phase II substudy was fully enrolled 3 months later. Contrasting conventional wisdom with trial outcomes offers an opportunity to compare early assumptions, barriers encountered, and adaptive strategies used, with end results. Understanding what was learned can inform future trial responses when disease outbreaks, especially in resource-poor locations with minimal infrastructure, pose a significant threat to public health. |
format | Online Article Text |
id | pubmed-5508914 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | The American Society of Tropical Medicine and Hygiene |
record_format | MEDLINE/PubMed |
spelling | pubmed-55089142017-07-25 Conventional Wisdom versus Actual Outcomes: Challenges in the Conduct of an Ebola Vaccine Trial in Liberia during the International Public Health Emergency Larson, Gregg S. Baseler, Beth R. Hoover, Marie L. Pierson, Jerome F. Tegli, Jemee K. Johnson, Melvin P. Kieh, Mark W. S. McNay, Laura A. Njoh, Wissedi Sio Am J Trop Med Hyg Perspective Pieces Clinical trials are challenging endeavors. Planning and implementing an investigational vaccine trial in Liberia, in the midst of an Ebola virus disease (EVD) epidemic that World Health Organization classified a public health emergency of international concern, presented extraordinary challenges. Normally, years of preparation and a litany of tasks lay the groundwork for a successful, randomized, blinded, placebo-controlled trial focused on safety and efficacy. Difficult research settings, unpredictable events, and other unique circumstances can add complexity. The setting in Liberia was especially problematic due to an infrastructure still badly damaged following a lengthy civil war and a very fragile health-care system that was further devastated by the EVD outbreak. The Partnership for Research on Vaccines in Liberia I EVD vaccine trial was planned and implemented in less than 3 months by a Liberian and U.S. research partnership, and its Phase II substudy was fully enrolled 3 months later. Contrasting conventional wisdom with trial outcomes offers an opportunity to compare early assumptions, barriers encountered, and adaptive strategies used, with end results. Understanding what was learned can inform future trial responses when disease outbreaks, especially in resource-poor locations with minimal infrastructure, pose a significant threat to public health. The American Society of Tropical Medicine and Hygiene 2017-07-12 2017-05-01 /pmc/articles/PMC5508914/ /pubmed/28719299 http://dx.doi.org/10.4269/ajtmh.16-1015 Text en © The American Society of Tropical Medicine and Hygiene This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://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 | Perspective Pieces Larson, Gregg S. Baseler, Beth R. Hoover, Marie L. Pierson, Jerome F. Tegli, Jemee K. Johnson, Melvin P. Kieh, Mark W. S. McNay, Laura A. Njoh, Wissedi Sio Conventional Wisdom versus Actual Outcomes: Challenges in the Conduct of an Ebola Vaccine Trial in Liberia during the International Public Health Emergency |
title | Conventional Wisdom versus Actual Outcomes: Challenges in the Conduct of an Ebola Vaccine Trial in Liberia during the International Public Health Emergency |
title_full | Conventional Wisdom versus Actual Outcomes: Challenges in the Conduct of an Ebola Vaccine Trial in Liberia during the International Public Health Emergency |
title_fullStr | Conventional Wisdom versus Actual Outcomes: Challenges in the Conduct of an Ebola Vaccine Trial in Liberia during the International Public Health Emergency |
title_full_unstemmed | Conventional Wisdom versus Actual Outcomes: Challenges in the Conduct of an Ebola Vaccine Trial in Liberia during the International Public Health Emergency |
title_short | Conventional Wisdom versus Actual Outcomes: Challenges in the Conduct of an Ebola Vaccine Trial in Liberia during the International Public Health Emergency |
title_sort | conventional wisdom versus actual outcomes: challenges in the conduct of an ebola vaccine trial in liberia during the international public health emergency |
topic | Perspective Pieces |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5508914/ https://www.ncbi.nlm.nih.gov/pubmed/28719299 http://dx.doi.org/10.4269/ajtmh.16-1015 |
work_keys_str_mv | AT larsongreggs conventionalwisdomversusactualoutcomeschallengesintheconductofanebolavaccinetrialinliberiaduringtheinternationalpublichealthemergency AT baselerbethr conventionalwisdomversusactualoutcomeschallengesintheconductofanebolavaccinetrialinliberiaduringtheinternationalpublichealthemergency AT hoovermariel conventionalwisdomversusactualoutcomeschallengesintheconductofanebolavaccinetrialinliberiaduringtheinternationalpublichealthemergency AT piersonjeromef conventionalwisdomversusactualoutcomeschallengesintheconductofanebolavaccinetrialinliberiaduringtheinternationalpublichealthemergency AT teglijemeek conventionalwisdomversusactualoutcomeschallengesintheconductofanebolavaccinetrialinliberiaduringtheinternationalpublichealthemergency AT johnsonmelvinp conventionalwisdomversusactualoutcomeschallengesintheconductofanebolavaccinetrialinliberiaduringtheinternationalpublichealthemergency AT kiehmarkws conventionalwisdomversusactualoutcomeschallengesintheconductofanebolavaccinetrialinliberiaduringtheinternationalpublichealthemergency AT mcnaylauraa conventionalwisdomversusactualoutcomeschallengesintheconductofanebolavaccinetrialinliberiaduringtheinternationalpublichealthemergency AT njohwissedisio conventionalwisdomversusactualoutcomeschallengesintheconductofanebolavaccinetrialinliberiaduringtheinternationalpublichealthemergency |