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Challenges of drug development during the COVID-19 pandemic: key considerations for clinical trial designs
  • +4
  • Jun Shi,
  • Yubo Xiao,
  • Yiting Zhang,
  • Donghao Geng,
  • Danhua Cong,
  • Kevin X. Shi,
  • Richard J. Knapp
Jun Shi
dMed
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Yiting Zhang
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Donghao Geng
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Danhua Cong
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Kevin X. Shi
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Richard J. Knapp
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Abstract

There is an urgent need for targeted and effective COVID-19 treatment. A number of medications, including hydroxychloroquine, remdesivir, lopinavir-ritonavir, fapiravir, and tocilizumab, have been identified as potential treatments for COVID-19. Bringing these repurposed medications to the public for COVID-19 will require robust and high-quality clinical trials. This article reviews translational science principles and strategies for conducting clinical trials in a pandemic and evaluates recent trials for each drug candidate. We hope that this knowledge will help focus efforts during this crisis and lead to the expedited development and approval of COVID-19 therapy.

Peer review status:UNDER REVIEW

15 Apr 2020Submitted to British Journal of Clinical Pharmacology
16 Apr 2020Submission Checks Completed
16 Apr 2020Assigned to Editor
19 Apr 2020Reviewer(s) Assigned
04 May 2020Review(s) Completed, Editorial Evaluation Pending
12 May 2020Editorial Decision: Revise Major
14 Jul 20201st Revision Received
15 Jul 2020Submission Checks Completed
15 Jul 2020Assigned to Editor
15 Jul 2020Review(s) Completed, Editorial Evaluation Pending
06 Aug 2020Reviewer(s) Assigned