The impact of the global COVID-19 pandemic on the conduct of clinical trials: Return to normalcy by considering the practical impact of a structured ethical analysis
Open accessAbstract
During the outbreak of the COVID-19 pandemic many clinical trials were abruptly halted. Measures to contain the pandemic are currently taking effect and societies in general and healthcare systems in particular are considering how to return to normalcy. This opens up the discussion when and how clinical trials should be restarted while the COVID-19 pandemic has not yet resolved, and what should happen in case of a resurgence of the virus in the coming months. This article uses the four ethical principles framework as a structured approach to come to a set of practical, ethically grounded guidelines for halting and relaunching clinical trials during the COVID-19 pandemic. The framework applied provides a structured approach for all clinical trials stakeholders and thereby prevents unclear reasoning in a complex situation. While it is essential to prevent the virus from resurging and focus on developing a COVID-19 treatment as soon as possible, it is just as important to our society that we continue developing new drugs for other conditions. In this article we argue that the situation for clinical trials is not essentially different from the pre-COVID-19 era and that an overcautious approach will have negative consequences.
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Although people who are at higher risk of infection could be more at-risk by participating in clinical trials during a pandemic, for certain areas like oncology, the potential benefits of taking part in a trial may outweigh the risks even where the pandemic makes individuals more vulnerable.
“It must be recognised that although people who are at higher risk of infection could be more at-risk by participating in clinical trials during a pandemic, for certain areas like oncology, the potential benefits of taking part in a trial may outweigh the risks even where the pandemic makes individuals more vulnerable [23].”
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- Authors
- Vissers, M. F. J. M., Cohen, A. F., Van Gerven, J. M. A., & Groeneveld, G. J.
- Affiliations
- Centre for Human Drug Research (NL)
- Leiden University Medical Center (NL)
- Leiden University Medical Center Albinusdreef 2 Leiden ZA 2333 The Netherlands
- Corresponding author
- Vissers, Maurits F.J.M.
- Venue
- British Journal of Clinical Pharmacology
- Publisher
- Wiley
- Published
- 2020-07-26
- Volume
- 87
- Issue
- 3
- Pages
- 837-844
- ISSN
- 0306-5251 (ISSN-L)
- 1365-2125
- OpenAlex
- W3043805919
- Cited by
- 25
- References
- 43
- Citations by year
- 2025: 2 · 2024: 8 · 2023: 3 · 2022: 3 · 2021: 9
- FWCI
- 0.63
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- British Journal of Clinical Pharmacology (publishedVersion)
- PubMed (publishedVersion)
- Leiden Repository (Leiden University) (submittedVersion, cc-by)
- Data Archiving and Networked Services (DANS) (submittedVersion, cc-by)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Medicine › Oncology › COVID-19 and healthcare impacts
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Keywords
- COVID-19 pandemic, research ethics, ethical analysis, pandemic containment measures, COVID-19 resurgence, drug development, research ethics guidelines
- MeSH terms
- COVID-19, Clinical Trials as Topic, Humans, Research Design, Ethical Analysis, Pandemics
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