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Reviews on Recent Clinical Trials

Editor-in-Chief

ISSN (Print): 1574-8871
ISSN (Online): 1876-1038

Review Article

COVID-19 and Clinical Trials: Current Challenges and Future Directions

Author(s): Vinay Singh*, Sandeep Garg, Monika Klimek, Rajeev Ranjan Sinha and Dinesh Dhanwal

Volume 16, Issue 3, 2021

Published on: 22 January, 2021

Page: [258 - 261] Pages: 4

DOI: 10.2174/1574887116666210122160705

Price: $65

Abstract

Background: The outbreak of coronavirus disease (COVID-19) has posed a major threat to people's lives across the globe. It has drastically changed the way we perceive this world. A paradigm shift was observed globally as the world’s emphasis shifted to testing, diagnosis, treatment, and developing a coronavirus cure. Clinical trials were also not untouched by this. The coronavirus pandemic has abhorrently affected the day-to-day clinical trial activities at sites.

Methods: The status of various ongoing clinical trials was assessed through a literature search, which also includes clinical trial portals. Our evaluations were based on these observations.

Results: Multiple challenges were present in clinical trials as recruitment, retention, the safety of trial subjects, protocol compliance, and this made the world to re-think to incorporate newer strategies and to cope with this untoward situation.

Conclusion: Digitalization of clinical trials as virtual management of adverse events, remote monitoring visits, and web-based consulting with trial subjects are potential directions that can be applied to better manage clinical trials worldwide.

Keywords: Clinical trials, challenges, coronavirus, COVID-19, strategies, digitalization.

Graphical Abstract

[1]
Wu Yi-Chia, Chen Ching-Sunga, Chan Yu-Jiun. The outbreak of COVID-19: An overview. J Chin Med Assoc 2020; 83(3): 217-20.
[2]
Hui DS, I, Azhar E, Madani TA, et al. The continuing 2019-nCoV epidemic threat of novel coronaviruses to global health: The latest 2019 novel coronavirus outbreak in Wuhan, China. Int J Infect Dis 2020; 91: 264-6.
[3]
[4]
Cui J, Li F, Shi Z-L. Origin and evolution of pathogenic coronaviruses. Nat Rev Microbiol 2019; 17(3): 181-92.
[http://dx.doi.org/10.1038/s41579-018-0118-9] [PMID: 30531947]
[5]
Lai C-C, Shih T-P, Ko W-C, Tang H-J, Hsueh PR. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents 2020; 55(3)
[http://dx.doi.org/10.1016/j.ijantimicag.2020.105924] [PMID: 32081636]
[6]
Organization W.H.. Laboratory testing for coronavirus disease 2019 (COVID-19) in suspected human cases: interim guidance 2020.
[7]
Poongothai S, Anjana RM, Aarthy R, et al. Strategies adopted in conduct of clinical trials amidst coronavirus disease-2019 (COVID-19). J Diabetol 2020; 11: 81-5.
[8]
Bhatt A. Clinical trials during the COVID-19 pandemic: Challenges of putting scientific and ethical principles into practice. Perspect Clin Res 2020; 11(2): 59-63.
[http://dx.doi.org/10.4103/picr.PICR_77_20] [PMID: 32670829]
[9]
CDSCO. Announced clinical trials conduct rules during COVID-19 outbreak https://cliniexperts.com/
[10]
European Medicines Agency. 2020.Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic, Version 3 https://ec.europa.eu/ health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_ covid19_en.pdf
[11]
FDA (Food and Drug Administration). FDA guidance on conduct of clinical trials of medical products during COVID19 public health emergency; guidance for industry, investigators, and institutional review boards 2020.https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/fda-guidance-conduct-clinical-trials-medicalproducts-during-covid-19-public-health-emergency
[12]
Health Canada Notification on Clinical Trial Management During COVID-19 Pandemic https://www.advarra.com/about-advarra/news/health-canada-clinical-trials-covid-19
[13]
COVID-19: Guidance on clinical trials for institutions, HRECs, researchers and sponsors https://www.nhmrc.gov.au/sites/default/files/documents/attachments/ctprg-statement-clinical-trials- covid.pdf
[15]
Fareed Melhem Medidata. The Global Impact of COVID-19 on Clinical Trials and the Way Forward. Industry Insight 2020.
[16]
Crystal M. North, Michael L. Dougan and Chana A. Sacks. Improving Clinical Trial Enrollment- In the Covid-19 Era and Beyond. N Engl J Med 2020; 15(383): 1406-8.
[http://dx.doi.org/10.1056/NEJMp2019989]
[17]
Khanna RC, Cicinelli MV, Gilbert SS, Honavar SG, Murthy GSV. COVID-19 pandemic: Lessons learned and future directions. Indian J Ophthalmol 2020; 68(5): 703-10.
[http://dx.doi.org/10.4103/ijo.IJO_843_20] [PMID: 32317432]
[18]
Baigent C, Harrell FE, Buyse M, Emberson JR, Altman DG. Ensuring trial validity by data quality assurance and diversification of monitoring methods. Clin Trials 2008; 5(1): 49-55.
[http://dx.doi.org/10.1177/1740774507087554] [PMID: 18283080]
[19]
Madhuri P. Remote Site Monitoring: The Future of Clinical Research. Curr Trends Biomedical Eng & Biosci 2017; 9(5)
[http://dx.doi.org/10.19080/CTBEB.2017.09.555771]
[20]
Muller MP, McGeer A, Straus SE, Hawryluck L, Gold WL. Clinical trials and novel pathogens: lessons learned from SARS. Emerg Infect Dis 2004; 10(3): 389-94.
[http://dx.doi.org/10.3201/eid1003.030702] [PMID: 15109402]

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