Selected article for: "clinical trial and epidemic outbreak duration"
Author: Qingyang Xu; Shomesh Chaudhuri; Danying Xiao; Andrew W Lo
Title: Bayesian Adaptive Clinical Trials for Anti-Infective Therapeutics during Epidemic Outbreaks
  • Document date: 2020_4_14
    • ID: 20hk99h4_1
    Snippet: With growing public concern over the outbreak of Coronavirus Disease 2019 (COVID-19), significant efforts have been undertaken by global biomedical stakeholders to develop effective diagnostics, vaccines, anti-viral drugs, medical devices, and other therapeutics against this highly infectious and deadly pandemic. While in the past, the traditional randomized clinical trial (RCT) and regulatory approval process often took several years (U.S. Food .....
    Document: With growing public concern over the outbreak of Coronavirus Disease 2019 (COVID-19), significant efforts have been undertaken by global biomedical stakeholders to develop effective diagnostics, vaccines, anti-viral drugs, medical devices, and other therapeutics against this highly infectious and deadly pandemic. While in the past, the traditional randomized clinical trial (RCT) and regulatory approval process often took several years (U.S. Food & Drug Administration, 2018)-longer than the typical duration of an epidemic outbreak (Pronker et al. 2013 )-recently the FDA has responded with actions such as the Breakthrough Devices Program, Emergency Use Authorization (EUA) authority, and Immediately in Effect guidance documents to prevent novel diagnostics and therapeutics from lagging behind the urgent needs of the population. In this paper, we propose adapting yet another tool that the FDA has already been exploring for medical devices (Chaudhuri et al. , 2019 to therapeutics for treating COVID-19 that are currently under development.

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