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A Cost/Benefit Analysis of Clinical Trial Designs for COVID-19 Vaccine Candidates COVID-19候选疫苗临床试验设计的成本/效益分析
Pub Date : 2020-09-18 DOI: 10.1101/2020.09.15.20195495
D. Berry, S. Berry, P. Hale, L. Isakov, A. Lo, K. W. Siah, Chi Heem Wong
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 randomized clinical trials and adaptive and human challenge trials. Using epidemiological models calibrated to the current pandemic, we simulate the time course of each clinical trial design for 504 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.
我们比较和对比了几种COVID-19候选疫苗临床试验设计的预期持续时间和避免的感染和死亡人数,包括传统的随机临床试验和适应性和人体挑战试验。使用针对当前大流行校准的流行病学模型,我们模拟了504种独特参数组合的每个临床试验设计的时间过程,使我们能够确定哪种试验设计对给定情景最有效。人体挑战试验提供了最大的净效益——与第二好的临床试验设计相比,在美国避免了110万例感染和8000例死亡——如果它的准备时间短或大流行传播缓慢的话。在大多数其他情况下,适应性试验提供更大的净效益。
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引用次数: 13
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PharmSciRN: Clinical Trial Design & Protocols (Sub-Topic)
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