A cost/benefit analysis of clinical trial designs for COVID-19 vaccine candidates.

We compare and contrast the expected duration and number of infections and deaths averted among several designs for clinical trials of COVID-19 vaccine candidates, including traditional and adaptive randomized clinical trials and human challenge trials. Using epidemiological models calibrated to the...

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Main Authors: Donald A Berry, Scott Berry, Peter Hale, Leah Isakov, Andrew W Lo, Kien Wei Siah, Chi Heem Wong
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2020-01-01
Series:PLoS ONE
Online Access:https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0244418&type=printable
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author Donald A Berry
Scott Berry
Peter Hale
Leah Isakov
Andrew W Lo
Kien Wei Siah
Chi Heem Wong
author_facet Donald A Berry
Scott Berry
Peter Hale
Leah Isakov
Andrew W Lo
Kien Wei Siah
Chi Heem Wong
author_sort Donald A Berry
collection DOAJ
description We compare and contrast the expected duration and number of infections and deaths averted among several designs for clinical trials of COVID-19 vaccine candidates, including traditional and adaptive randomized clinical trials and human challenge trials. Using epidemiological models calibrated to the current pandemic, we simulate the time course of each clinical trial design for 756 unique combinations of parameters, allowing us to determine which trial design is most effective for a given scenario. A human challenge trial provides maximal net benefits-averting an additional 1.1M infections and 8,000 deaths in the U.S. compared to the next best clinical trial design-if its set-up time is short or the pandemic spreads slowly. In most of the other cases, an adaptive trial provides greater net benefits.
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institution Kabale University
issn 1932-6203
language English
publishDate 2020-01-01
publisher Public Library of Science (PLoS)
record_format Article
series PLoS ONE
spelling doaj-art-30e6ac668198414a8c970e0215f9ac9b2025-02-05T05:33:00ZengPublic Library of Science (PLoS)PLoS ONE1932-62032020-01-011512e024441810.1371/journal.pone.0244418A cost/benefit analysis of clinical trial designs for COVID-19 vaccine candidates.Donald A BerryScott BerryPeter HaleLeah IsakovAndrew W LoKien Wei SiahChi Heem WongWe compare and contrast the expected duration and number of infections and deaths averted among several designs for clinical trials of COVID-19 vaccine candidates, including traditional and adaptive randomized clinical trials and human challenge trials. Using epidemiological models calibrated to the current pandemic, we simulate the time course of each clinical trial design for 756 unique combinations of parameters, allowing us to determine which trial design is most effective for a given scenario. A human challenge trial provides maximal net benefits-averting an additional 1.1M infections and 8,000 deaths in the U.S. compared to the next best clinical trial design-if its set-up time is short or the pandemic spreads slowly. In most of the other cases, an adaptive trial provides greater net benefits.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0244418&type=printable
spellingShingle Donald A Berry
Scott Berry
Peter Hale
Leah Isakov
Andrew W Lo
Kien Wei Siah
Chi Heem Wong
A cost/benefit analysis of clinical trial designs for COVID-19 vaccine candidates.
PLoS ONE
title A cost/benefit analysis of clinical trial designs for COVID-19 vaccine candidates.
title_full A cost/benefit analysis of clinical trial designs for COVID-19 vaccine candidates.
title_fullStr A cost/benefit analysis of clinical trial designs for COVID-19 vaccine candidates.
title_full_unstemmed A cost/benefit analysis of clinical trial designs for COVID-19 vaccine candidates.
title_short A cost/benefit analysis of clinical trial designs for COVID-19 vaccine candidates.
title_sort cost benefit analysis of clinical trial designs for covid 19 vaccine candidates
url https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0244418&type=printable
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