Literature DB >> 33119136

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

Jun Shi1, Yubo Xiao1, Yiting Zhang1, Donghao Geng1, Danhua Cong1, Kevin X Shi2, Richard J Knapp3.   

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.
© 2020 British Pharmacological Society.

Entities:  

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

Year:  2020        PMID: 33119136     DOI: 10.1111/bcp.14629

Source DB:  PubMed          Journal:  Br J Clin Pharmacol        ISSN: 0306-5251            Impact factor:   4.335


  4 in total

1.  Key Considerations for Phase 2 or 3 Clinical Study Design of Anti-Inflammatory Agent for COVID-19 Treatment.

Authors:  Yewon Park; Joo Young Na; Joo-Youn Cho; Jaeseong Oh; Su-Jin Rhee
Journal:  Front Pharmacol       Date:  2022-06-02       Impact factor: 5.988

2.  Pineal hormone melatonin as an adjuvant treatment for COVID‑19 (Review).

Authors:  Marilena Vlachou; Angeliki Siamidi; Aikaterini Dedeloudi; Sofia K Konstantinidou; Ioannis P Papanastasiou
Journal:  Int J Mol Med       Date:  2021-02-12       Impact factor: 4.101

3.  Calibration and Validation of a Mechanistic COVID-19 Model for Translational Quantitative Systems Pharmacology - A Proof-of-Concept Model Development for Remdesivir.

Authors:  Mohammadreza Samieegohar; James L Weaver; Kristina E Howard; Anik Chaturbedi; John Mann; Xiaomei Han; Joel Zirkle; Ghazal Arabidarrehdor; Rodney Rouse; Jeffry Florian; David G Strauss; Zhihua Li
Journal:  Clin Pharmacol Ther       Date:  2022-06-29       Impact factor: 6.903

Review 4.  Translational precision medicine: an industry perspective.

Authors:  Dominik Hartl; Valeria de Luca; Anna Kostikova; Jason Laramie; Scott Kennedy; Enrico Ferrero; Richard Siegel; Martin Fink; Sohail Ahmed; John Millholland; Alexander Schuhmacher; Markus Hinder; Luca Piali; Adrian Roth
Journal:  J Transl Med       Date:  2021-06-05       Impact factor: 5.531

  4 in total

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