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The impact of COVID-19 on the clinical trial.
Open accessAbstract
The objective of this study was to explore the impact of the coronavirus disease 2019 epidemic on ongoing and upcoming drug clinical trials. Qualitative semi-structured interviews were conducted with clinical trial staff and clinical trial subjects were surveyed by questionnaire in this study. The results of interviews and questionnaire showed that coronavirus disease 2019 pandemic has led to many changes in the implementation of drug clinical trials, including: a variety of meetings being held online webinars using various platforms, telemedicine and follow-up by video, A large number of deviations from protocol and losses of follow-up, delivery of clinical trial drugs by express, additional workload caused by screening for coronavirus, and anxiety of subjects. These results suggest that the coronavirus disease 2019 outbreak has hindered the progress and damaged the quality of clinical trials. The online meeting, remote follow-up, express delivery of drugs and remote monitoring in the epidemic environment can ensure the progress of clinical trials to a certain extent, but they cannot fully guarantee the quality as before.
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Concerns during the pandemic included worry that visiting health settings could pose a threat to the participant's health from infection of Covid-19.
“difficulties understanding safety protocols or perceptions that health sites were not stringent enough and [2] worry that visiting health settings could pose a threat to the participant’s health from infection of Covid-19 [6,9].”
From Legacy lessons from the COVID-19 era to improve trial participation and retention: Views from trial participants, PPIE contributors and trial staff across the NIHR portfolio (2024) · cites this paper as [9]
The Results questionnaire table (page not provided) reports pandemic-related anxiety and difficulty getting to hospital among trial participants. The Results section on changes in subjects’ emotions links anxiety to transport difficulties and isolation requirements, but neither passage says participants worried that visiting health settings would expose them to COVID-19 infection. (LLM, conf=0.81)
Experimental — accuracy not yet measuredConcerns during the pandemic included difficulties understanding safety protocols or perceptions that health sites were not stringent enough.
“difficulties understanding safety protocols or perceptions that health sites were not stringent enough and [2] worry that visiting health settings could pose a threat to the participant’s health from infection of Covid-19 [6,9].”
From Legacy lessons from the COVID-19 era to improve trial participation and retention: Views from trial participants, PPIE contributors and trial staff across the NIHR portfolio (2024) · cites this paper as [9]
The Results questionnaire reports anxiety and difficulty getting to hospital during COVID-19, but does not identify difficulty understanding safety protocols or perceptions that health sites were insufficiently stringent. The Discussion likewise addresses trial procedures and subject safety without reporting those specific concerns; searches for safety-protocol understanding and perceived site precautions found no supporting passage. Our copy provides no page numbers for these passages. (LLM, conf=0.73)
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Metadata
- Authors
- Chen, Z., Chen, L., & Chen, H.
- Affiliations
- First Affiliated Hospital of Wenzhou Medical University (CN)
- Corresponding author
- Chen, Zhimin
- Venue
- PLoS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2021-05-11
- Volume
- 16
- Issue
- 5
- Pages
- e0251410
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC8112689
- OpenAlex
- W3160918054
- Cited by
- 43
- References
- 15
- Citations by year
- 2026: 3 · 2025: 6 · 2024: 8 · 2023: 11 · 2022: 12 · 2021: 3
- FWCI
- 3.10
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- PLoS ONE (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Tang Wealth Investment Management Co.
- Topics
- Health Sciences › Medicine › Oncology › COVID-19 and healthcare impacts
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Social Sciences › Education › Education during COVID-19 pandemic
- Keywords
- COVID-19 pandemic, clinical trials, clinical drug trials, loss to follow-up, remote follow-up, telemedicine, virtual meetings, clinical trial quality
- MeSH terms
- COVID-19, SARS-CoV-2, COVID-19 Drug Treatment, Adult, Antiviral Agents, Anxiety, Clinical Trials as Topic, Humans, Interviews as Topic, Middle Aged, Patients, Surveys and Questionnaires, Research Personnel, Telemedicine, Young Adult, Pandemics
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