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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Bibliographic Details
Published in:PloS one 2020-12, Vol.15 (12), p.e0244418-e0244418
Main Authors: Berry, Donald A, Berry, Scott, Hale, Peter, Isakov, Leah, Lo, Andrew W, Siah, Kien Wei, Wong, Chi Heem
Format: Article
Language:English
Subjects:
Analysis
Biology and Life Sciences
Clinical trials
Clinical Trials as Topic
Cost benefit analysis
COVID-19 - epidemiology
COVID-19 - prevention & control
COVID-19 - therapy
COVID-19 - virology
COVID-19 Vaccines - standards
COVID-19 Vaccines - therapeutic use
Experimental design
Humans
Medicine and Health Sciences
Pandemics
Research and Analysis Methods
SARS-CoV-2 - drug effects
SARS-CoV-2 - pathogenicity
Vaccination
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Summary: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.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0244418