Challenges of drug development during the COVID-19 pandemic: key
considerations for clinical trial designs
- Jun Shi,
- Yubo Xiao,
- Yiting Zhang,
- Donghao Geng,
- Danhua Cong,
- Kevin X. Shi,
- Richard J. Knapp
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.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
14 Oct 2020Editorial Decision: Accept