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

Author(s)
Berry, Donald A.; Berry, Scott; Hale, Peter; Isakov, Leah; Lo, Andrew W; Siah, Kien Wei; Wong, Chi Heem; ... Show more Show less
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Creative Commons Attribution 4.0 International license https://creativecommons.org/licenses/by/4.0/
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Abstract
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.
Date issued
2020-12
URI
https://hdl.handle.net/1721.1/130143
Department
Sloan School of Management; Massachusetts Institute of Technology. Department of Electrical Engineering and Computer Science
Journal
PLoS ONE
Publisher
Public Library of Science (PLoS)
Citation
Berry, Donald A."A cost/benefit analysis of clinical trial designs for COVID-19 vaccine candidates." PLoS ONE 15, 12 (December 2020): e0244418. © 2020 Berry et al.
Version: Final published version
ISSN
1932-6203

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