Challenges of drug development during the COVID-19 pandemic: Key considerations for clinical trial designs

Br J Clin Pharmacol. 2021 May;87(5):2170-2185. doi: 10.1111/bcp.14629. Epub 2020 Dec 10.

Abstract

There is an urgent need for targeted and effective COVID-19 treatments. Several medications, including hydroxychloroquine, remdesivir, lopinavir-ritonavir, favipiravir, tocilizumab and others have been identified as potential treatments for COVID-19. Bringing these repurposed medications to the public for COVID-19 requires robust and high-quality clinical trials that must be conducted under extremely challenging pandemic conditions. This article reviews translational science principles and strategies for conducting clinical trials in a pandemic and evaluates recent trials for different drug candidates. We hope that this knowledge will help focus efforts during this crisis and lead to the expedited development and approval of COVID-19 therapies.

Keywords: COVID-19; SARS-CoV-2; antiviral drugs; clinical trial design; drug development; translational science.

Publication types

  • Review

MeSH terms

  • Antiviral Agents / therapeutic use*
  • COVID-19 Drug Treatment*
  • Clinical Trials as Topic*
  • Drug Development*
  • Humans
  • Pandemics*
  • Translational Research, Biomedical

Substances

  • Antiviral Agents