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A cost/benefit analysis of clinical trial designs for COVID-19 vaccine candidates.
Berry, Donald A; Berry, Scott; Hale, Peter; Isakov, Leah; Lo, Andrew W; Siah, Kien Wei; Wong, Chi Heem.
  • Berry DA; Department of Biostatistics, University of Texas, Houston, Texas, United States of America.
  • Berry S; Berry Consultants, Austin, Texas, United States of America.
  • Hale P; Berry Consultants, Austin, Texas, United States of America.
  • Isakov L; The Foundation for Vaccine Research, Washington, D.C., United States of America.
  • Lo AW; Seqirus, Cambridge, Massachusetts, United States of America.
  • Siah KW; MIT Sloan School of Management, Cambridge, Massachusetts, United States of America.
  • Wong CH; Department of Electrical Engineering and Computer Science, Massachusetts Institute of Technology, Cambridge, Massachusetts, United States of America.
PLoS One ; 15(12): e0244418, 2020.
Article in English | MEDLINE | ID: covidwho-999841
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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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Cost-Benefit Analysis / COVID-19 Vaccines / SARS-CoV-2 / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: PLoS One Journal subject: Science / Medicine Year: 2020 Document Type: Article Affiliation country: Journal.pone.0244418

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Cost-Benefit Analysis / COVID-19 Vaccines / SARS-CoV-2 / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: PLoS One Journal subject: Science / Medicine Year: 2020 Document Type: Article Affiliation country: Journal.pone.0244418